From fbf35a3209654b484264466c5676bb2af23d7efc Mon Sep 17 00:00:00 2001 From: AtomicQMS Service Date: Sat, 27 Dec 2025 11:24:13 -0500 Subject: [PATCH] Sync template from atomicqms-style deployment --- .gitea/workflows/atomicai.yml | 90 +++++ ...-LIC-001-License-Requirements-Checklist.md | 145 ++++++++ .../FRM-LIC-002-License-Tracking-Database.md | 113 ++++++ Forms/Scoring/.gitkeep | 0 .../FRM-SCR-001-Scoring-Algorithm-Template.md | 281 +++++++++++++++ Forms/Training/.gitkeep | 0 ...M-TRN-001-Administrator-Training-Record.md | 185 ++++++++++ .../FRM-VAL-001-Validation-Study-Protocol.md | 315 +++++++++++++++++ Policies/POL-001-Quality-Policy.md | 104 ++++++ README.md | 118 ++++++- .../SOP-ADM-001-Measure-Administration.md | 312 ++++++++++++++++ SOPs/Data-Management/.gitkeep | 0 SOPs/General/.gitkeep | 0 SOPs/General/SOP-GEN-001-Document-Control.md | 219 ++++++++++++ .../SOP-GEN-002-Training-Competence.md | 317 +++++++++++++++++ .../SOP-LIC-001-License-Management.md | 189 ++++++++++ ...N-001-Translation-Linguistic-Validation.md | 333 ++++++++++++++++++ .../SOP-VAL-001-Psychometric-Validation.md | 259 ++++++++++++++ Templates/SOP-Template.md | 69 ++++ Work Instructions/WI-001-Template.md | 104 ++++++ 20 files changed, 3151 insertions(+), 2 deletions(-) create mode 100644 .gitea/workflows/atomicai.yml create mode 100644 Forms/License-Tracking/FRM-LIC-001-License-Requirements-Checklist.md create mode 100644 Forms/License-Tracking/FRM-LIC-002-License-Tracking-Database.md create mode 100644 Forms/Scoring/.gitkeep create mode 100644 Forms/Scoring/FRM-SCR-001-Scoring-Algorithm-Template.md create mode 100644 Forms/Training/.gitkeep create mode 100644 Forms/Training/FRM-TRN-001-Administrator-Training-Record.md create mode 100644 Forms/Validation-Records/FRM-VAL-001-Validation-Study-Protocol.md create mode 100644 Policies/POL-001-Quality-Policy.md create mode 100644 SOPs/Administration/SOP-ADM-001-Measure-Administration.md create mode 100644 SOPs/Data-Management/.gitkeep create mode 100644 SOPs/General/.gitkeep create mode 100644 SOPs/General/SOP-GEN-001-Document-Control.md create mode 100644 SOPs/General/SOP-GEN-002-Training-Competence.md create mode 100644 SOPs/Licensing/SOP-LIC-001-License-Management.md create mode 100644 SOPs/Translation/SOP-TRN-001-Translation-Linguistic-Validation.md create mode 100644 SOPs/Validation/SOP-VAL-001-Psychometric-Validation.md create mode 100644 Templates/SOP-Template.md create mode 100644 Work Instructions/WI-001-Template.md diff --git a/.gitea/workflows/atomicai.yml b/.gitea/workflows/atomicai.yml new file mode 100644 index 0000000..2c9e7dd --- /dev/null +++ b/.gitea/workflows/atomicai.yml @@ -0,0 +1,90 @@ +name: AtomicAI Clinical Measure Repository Assistant + +on: + issue_comment: + types: [created] + issues: + types: [opened, assigned] + pull_request: + types: [opened, synchronize, assigned] + pull_request_review_comment: + types: [created] + +jobs: + claude-assistant: + runs-on: ubuntu-latest + if: | + github.actor != 'atomicqms-service' && + ( + (github.event_name == 'issue_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') || + (github.event_name == 'issues' && github.event.action == 'opened' && contains(github.event.issue.body, '@atomicai')) || + (github.event_name == 'pull_request' && github.event.action == 'opened' && contains(github.event.pull_request.body, '@atomicai')) || + (github.event_name == 'pull_request_review_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') || + (github.event.action == 'assigned' && github.event.assignee.login == 'atomicai') + + ) + permissions: + contents: write + issues: write + pull-requests: write + + steps: + - uses: actions/checkout@v4 + with: + fetch-depth: 0 + + - name: Run AtomicAI Clinical Measure Repository Assistant + uses: https://beta.atomicqms.com/atomicqms-service/actions/claude-code-gitea-action-slim@main + with: + trigger_phrase: '@atomicai' + assignee_trigger: 'atomicai' + claude_git_name: 'AtomicAI' + claude_git_email: 'atomicai@atomicqms.local' + custom_instructions: | + You are AtomicAI, an AI assistant specialized in Clinical Outcome Measures and Patient-Reported Outcomes Quality Management. + + ## Your Expertise + - Clinical outcome measure development and validation + - Patient-Reported Outcomes (PROs), Clinician-Reported Outcomes (ClinROs), Observer-Reported Outcomes (ObsROs) + - Performance Outcomes (PerfOs) and objective assessments + - FDA PRO Guidance and BEST (Biomarkers, EndpointS, and other Tools) Framework + - Psychometric validation: reliability, validity, responsiveness, interpretability + - Measure licensing, copyright, and intellectual property management + - Translation and linguistic validation (ISPOR guidelines) + - Electronic Clinical Outcome Assessment (eCOA) protocols + - Scoring algorithms and normative data interpretation + - Measure administration training and certification requirements + - PROMIS (Patient-Reported Outcomes Measurement Information System) + - NIH Toolbox, COSMIN guidelines, Consensus-based Standards for the selection of health Measurement Instruments + + ## Document Creation Guidelines + - Place Licensing SOPs in SOPs/Licensing/ + - Place Validation SOPs in SOPs/Validation/ + - Place Administration SOPs in SOPs/Administration/ + - Place Translation SOPs in SOPs/Translation/ + - Place Data Management SOPs in SOPs/Data-Management/ + - Place General SOPs in SOPs/General/ + - Place License tracking forms in Forms/License-Tracking/ + - Place Validation records in Forms/Validation-Records/ + - Place Training records in Forms/Training/ + - Place Scoring documentation in Forms/Scoring/ + - Place Work Instructions in Work Instructions/ + + ## Numbering Convention + - POL-XXX for Policies + - SOP-LIC-XXX for Licensing SOPs + - SOP-VAL-XXX for Validation SOPs + - SOP-ADM-XXX for Administration SOPs + - SOP-TRN-XXX for Translation SOPs + - SOP-DM-XXX for Data Management SOPs + - SOP-GEN-XXX for General SOPs + - WI-XXX for Work Instructions + - FRM-XXX for Forms + - LIC-XXX for License Agreements/Tracking + - VAL-XXX for Validation Reports + - SCR-XXX for Scoring Algorithms + + Always create branches and submit changes as Pull Requests for review. + Include regulatory references (FDA PRO Guidance, ICH E9, ISPOR) where applicable. + allowed_tools: 'Read,Edit,Grep,Glob,Write' + disallowed_tools: 'Bash,WebSearch' diff --git a/Forms/License-Tracking/FRM-LIC-001-License-Requirements-Checklist.md b/Forms/License-Tracking/FRM-LIC-001-License-Requirements-Checklist.md new file mode 100644 index 0000000..97a8891 --- /dev/null +++ b/Forms/License-Tracking/FRM-LIC-001-License-Requirements-Checklist.md @@ -0,0 +1,145 @@ +# License Requirements Checklist + +| Form ID | FRM-LIC-001 | +|---------|-------------| +| Form Title | License Requirements Checklist | +| Version | 1.0 | +| Effective Date | [DATE] | + +--- + +## Measure Information + +| Field | Information | +|-------|-------------| +| Measure Name | | +| Version/Form | | +| Measure Type | ☐ PRO ☐ ClinRO ☐ ObsRO ☐ PerfO | +| Purpose/Study | | +| Protocol Number | | + +## Copyright Status + +| Field | Response | +|-------|----------| +| Copyright Holder | | +| Copyright Holder Contact | | +| Website | | + +### Copyright Classification + +☐ **Public Domain** +- No copyright restrictions +- Free to use without permission +- No license required + +☐ **Open Access with Attribution** +- Free to use +- Attribution required +- Specific citation format: _____________________ + +☐ **Proprietary - License Required** +- Paid license required +- License type needed: ☐ Academic ☐ Commercial ☐ Clinical +- Proceed to License Requirements section + +☐ **Special Permission Required** +- Must contact copyright holder for permission +- Restrictions on use: _____________________ + +## License Requirements (if applicable) + +### License Type Options + +| License Type | Cost | Terms | Notes | +|--------------|------|-------|-------| +| Single Study | | | | +| Multi-Study | | | | +| Institutional | | | | +| Commercial | | | | + +### Scope of Use + +Number of Participants: _________ + +Study Sites/Locations: _________________________________________ + +Countries: ___________________________________________________ + +Study Duration: From __________ to __________ + +### Administration Mode + +☐ Paper-based +☐ Electronic (eCOA) + - Platform: _____________________ + - Additional fees for electronic use? ☐ Yes ☐ No + +### Translation Requirements + +Languages needed: _____________________________________________ + +☐ Official translations available +☐ New translation required (see SOP-TRN-001) +☐ Translation included in license +☐ Translation requires additional fee + +### Special Requirements/Restrictions + +☐ Training/certification required for administrators +☐ Restrictions on modifications +☐ Requirements for result reporting to copyright holder +☐ Publication acknowledgment required +☐ Royalty fees for commercial use + +Details: ________________________________________________________ +________________________________________________________________ +________________________________________________________________ + +## Action Items + +| Action | Responsible | Target Date | Status | +|--------|-------------|-------------|--------| +| Contact copyright holder | | | | +| Obtain license application | | | | +| Complete application | | | | +| Legal review | | | | +| Obtain approval signatures | | | | +| Submit payment | | | | +| File executed license | | | | + +## Documentation Checklist + +☐ Copyright holder contact information verified +☐ License application obtained +☐ License terms reviewed +☐ Legal review completed (if required) +☐ Budget approved for license fees +☐ License application submitted +☐ License agreement received and executed +☐ Payment processed +☐ License filed in License Tracking Database (FRM-LIC-002) +☐ Project team notified of license status + +## Notes/Additional Information + +________________________________________________________________ +________________________________________________________________ +________________________________________________________________ +________________________________________________________________ + +--- + +## Signatures + +| Role | Name | Signature | Date | +|------|------|-----------|------| +| Completed By | | | | +| Reviewed By | | | | + +--- + +**Related Documents:** +- SOP-LIC-001: License Management for Proprietary Outcome Measures +- FRM-LIC-002: License Tracking Database +- SOP-VAL-001: Measure Selection and Validation diff --git a/Forms/License-Tracking/FRM-LIC-002-License-Tracking-Database.md b/Forms/License-Tracking/FRM-LIC-002-License-Tracking-Database.md new file mode 100644 index 0000000..4287cc9 --- /dev/null +++ b/Forms/License-Tracking/FRM-LIC-002-License-Tracking-Database.md @@ -0,0 +1,113 @@ +# License Tracking Database + +| Form ID | FRM-LIC-002 | +|---------|-------------| +| Form Title | License Tracking Database | +| Version | 1.0 | +| Effective Date | [DATE] | + +--- + +## Purpose + +This database tracks all active licenses for proprietary clinical outcome measures to ensure compliance with license terms and timely renewals. + +## Instructions + +1. Create a new entry for each measure license +2. Update status as actions are completed +3. Set calendar reminders for renewal dates (90 days, 30 days, expiration) +4. Review quarterly for accuracy and upcoming renewals +5. Archive completed entries when measures are no longer in use + +--- + +## License Tracking Table + +| Measure Name | Copyright Holder | License Number | License Type | Execution Date | Expiration Date | Covered Studies/Protocols | Cost | Payment Status | Renewal Status | File Location | Notes | +|--------------|------------------|----------------|--------------|----------------|-----------------|---------------------------|------|----------------|----------------|---------------|-------| +| | | | | | | | | | | | | +| | | | | | | | | | | | | +| | | | | | | | | | | | | +| | | | | | | | | | | | | +| | | | | | | | | | | | | +| | | | | | | | | | | | | +| | | | | | | | | | | | | + +## Field Definitions + +**Measure Name:** Full name and version of outcome measure + +**Copyright Holder:** Name of organization or individual holding copyright + +**License Number:** Unique identifier assigned by copyright holder + +**License Type:** +- Single Study +- Multi-Study +- Institutional +- Commercial +- Other + +**Execution Date:** Date license agreement was signed + +**Expiration Date:** Date license expires (leave blank for perpetual licenses) + +**Covered Studies/Protocols:** List of protocols covered under this license + +**Cost:** Total license fee + +**Payment Status:** +- Pending +- Paid +- Overdue + +**Renewal Status:** +- Active +- Renewal in Progress +- Renewal Needed (90 days) +- Renewal Urgent (30 days) +- Expired +- Discontinued + +**File Location:** Where executed license agreement is stored + +**Notes:** Restrictions, special terms, administrator requirements, etc. + +--- + +## Quarterly Review + +Review Date: __________ Reviewed By: __________ + +### Licenses Expiring in Next 90 Days + +| Measure | Expiration Date | Action Plan | +|---------|----------------|-------------| +| | | | +| | | | + +### Issues Identified + +| Issue | Measure | Resolution Plan | Target Date | +|-------|---------|----------------|-------------| +| | | | | +| | | | | + +### Action Items + +☐ Renewal reminders sent +☐ All licenses current and compliant +☐ Payment status verified +☐ File locations confirmed accessible +☐ New measures added to tracking +☐ Discontinued measures archived + +Reviewer Signature: ________________ Date: __________ + +--- + +**Related Documents:** +- SOP-LIC-001: License Management for Proprietary Outcome Measures +- FRM-LIC-001: License Requirements Checklist +- FRM-LIC-003: License Renewal Request Form diff --git a/Forms/Scoring/.gitkeep b/Forms/Scoring/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Scoring/FRM-SCR-001-Scoring-Algorithm-Template.md b/Forms/Scoring/FRM-SCR-001-Scoring-Algorithm-Template.md new file mode 100644 index 0000000..8e55dba --- /dev/null +++ b/Forms/Scoring/FRM-SCR-001-Scoring-Algorithm-Template.md @@ -0,0 +1,281 @@ +# Scoring Algorithm Documentation + +| Form ID | SCR-XXX | +|---------|-------------| +| Measure Name | | +| Measure Version | | +| Algorithm Version | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | + +--- + +## 1. Measure Overview + +| Field | Information | +|-------|-------------| +| Full Measure Name | | +| Measure Type | ☐ PRO ☐ ClinRO ☐ ObsRO ☐ PerfO | +| Copyright Holder | | +| License Status | | +| Number of Items | | +| Subscales | | +| Recall Period | | +| Administration Time | | + +## 2. Item Response Coding + +### Response Format + +☐ Likert Scale +☐ Visual Analog Scale (VAS) +☐ Binary (Yes/No) +☐ Numeric Rating Scale +☐ Other: _____________________ + +### Item Coding Table + +| Item Number | Item Content Summary | Response Options | Numeric Coding | Reverse Scored | +|-------------|---------------------|------------------|----------------|----------------| +| 1 | | | | ☐ Yes ☐ No | +| 2 | | | | ☐ Yes ☐ No | +| 3 | | | | ☐ Yes ☐ No | +| 4 | | | | ☐ Yes ☐ No | +| 5 | | | | ☐ Yes ☐ No | + +[Continue for all items] + +## 3. Scoring Procedures + +### 3.1 Item-Level Scoring + +#### Step 1: Code Raw Responses +- Convert response selections to numeric values per coding table +- For VAS items: measure distance from anchor (usually in mm, 0-100) +- For open-ended items: follow specific coding instructions + +#### Step 2: Reverse Score Items (if applicable) + +**Reverse-Scored Items:** [List item numbers] + +**Reverse Scoring Formula:** +- For X-point scale: Reversed Score = (X + 1) - Raw Score +- Example for 5-point scale: Reversed Score = 6 - Raw Score + +#### Step 3: Handle Missing Data + +**Missing Data Rules:** + +☐ **Prorated Scoring:** If ≥ ___% of items completed, prorate missing values + Formula: Scale Score = (Sum of completed items / Number of completed items) × Number of items in scale + +☐ **Person-Specific Mean Substitution:** Replace missing with person's mean on completed items + +☐ **No Imputation:** Score only if all items completed + +☐ **Copyright Holder Specified Rule:** ________________________________ + +**Maximum Allowable Missing Data:** +- Total scale: _____ items or _____% +- Per subscale: _____ items or _____% + +### 3.2 Subscale Scoring + +| Subscale Name | Items Included | Scoring Formula | Possible Range | Higher Score Means | +|---------------|----------------|-----------------|----------------|-------------------| +| | | | | | +| | | | | | +| | | | | | + +**Subscale Calculation Steps:** +1. Sum or average item scores per subscale +2. Apply any subscale-specific transformations +3. Round to _____ decimal places (specify) + +### 3.3 Total Score Calculation + +**Total Score Formula:** +________________________________________________________________ + +**Calculation Method:** +☐ Sum of all items +☐ Average of all items +☐ Sum of subscales +☐ Weighted sum: ______________________________________________ +☐ Other: ____________________________________________________ + +**Possible Score Range:** Minimum: _____ Maximum: _____ + +### 3.4 Transformations (if applicable) + +☐ **Linear Transformation** +Formula: Transformed Score = ___________________________________ + +☐ **T-Score Transformation** +Formula: T = 50 + 10 × (Raw Score - Mean) / SD +Population norms: Mean = _____ SD = _____ + +☐ **Percentile Conversion** +Reference normative data: _____________________________________ + +☐ **IRT-Based Scoring** +Scoring method: _______________________________________________ +Scoring software/table: ________________________________________ + +## 4. Score Interpretation + +### 4.1 Descriptive Statistics + +**General Population Norms:** +- Mean: _____ +- Standard Deviation: _____ +- Median: _____ +- Range: _____ + +**Clinical Population Norms:** +- Mean: _____ +- Standard Deviation: _____ + +### 4.2 Clinical Cutoffs + +| Score Range | Severity Level | Clinical Interpretation | +|-------------|---------------|------------------------| +| | None/Minimal | | +| | Mild | | +| | Moderate | | +| | Severe | | + +### 4.3 Minimal Clinically Important Difference (MCID) + +**Distribution-Based Estimates:** +- 0.5 SD = _____ +- 1 SEM = _____ + +**Anchor-Based Estimates:** +- Based on [anchor]: MCID = _____ +- 95% CI: [_____ to _____] + +**Recommended MCID for Clinical Use:** _____ + +Reference: ________________________________________________________ + +### 4.4 Subscale Interpretation + +**Subscale 1: [Name]** +- Score range: _____ to _____ +- Interpretation: ______________________________________________ + +**Subscale 2: [Name]** +- Score range: _____ to _____ +- Interpretation: ______________________________________________ + +## 5. Quality Control Checks + +### 5.1 Data Quality Flags + +☐ All items within valid range +☐ Required items completed +☐ Logical consistency checks passed +☐ Response patterns not suspicious (e.g., all same value) +☐ Missing data within acceptable limits + +### 5.2 Common Scoring Errors to Avoid + +- [ ] Forgetting to reverse score applicable items +- [ ] Incorrect handling of missing data +- [ ] Using wrong subscale item groupings +- [ ] Misinterpreting response codes +- [ ] Applying transformations incorrectly +- [ ] Using outdated scoring algorithms + +## 6. Implementation + +### 6.1 Manual Scoring + +**Required Materials:** +- Completed measure form +- Scoring template/worksheet +- Calculator +- Reverse scoring reference + +**Estimated Time:** _____ minutes per assessment + +### 6.2 Automated Scoring + +**Available Software/Systems:** +- [ ] REDCap scoring module +- [ ] eCOA platform automated scoring +- [ ] Statistical software (SAS/R/SPSS) script +- [ ] Excel scoring template +- [ ] Copyright holder proprietary software +- [ ] Other: _____________________ + +**Software Version:** _____________ + +**Validation Status:** ☐ Validated against manual scoring ☐ Not validated + +### 6.3 eCOA Considerations + +☐ Real-time scoring at completion +☐ Delayed scoring after data review +☐ Immediate feedback to participant: ☐ Yes ☐ No +☐ Score visibility to clinician: ☐ Yes ☐ No + +## 7. Documentation Requirements + +### 7.1 Scoring Records + +For each completed measure, maintain: +- [ ] Original completed measure form (source document) +- [ ] Scoring worksheet if manual scoring +- [ ] Computed scores (all subscales and total) +- [ ] Missing data documentation +- [ ] Quality control verification +- [ ] Scorer name/ID and date + +### 7.2 Algorithm Updates + +**Version Control:** +- Document all changes to scoring algorithm +- Maintain version history +- Specify effective date for each version +- Map to measure version +- Obtain copyright holder approval if required + +## 8. References + +**Primary Source:** +[Measure developer's manual or primary publication] + +**Validation Evidence:** +[Key validation publications] + +**Normative Data:** +[Sources for population norms] + +**MCID Evidence:** +[Publications establishing MCID] + +## 9. Contact Information + +**For Scoring Questions:** +[Internal expert contact] + +**Copyright Holder Support:** +[Copyright holder contact information] + +--- + +## Revision History + +| Version | Date | Changes | Approved By | +|---------|------|---------|-------------| +| 1.0 | [DATE] | Initial release | [APPROVER] | + +--- + +**Related Documents:** +- SOP-ADM-001: Clinical Outcome Measure Administration +- WI-XXX: [Measure-Specific Work Instruction] +- License Agreement: [License number] diff --git a/Forms/Training/.gitkeep b/Forms/Training/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Training/FRM-TRN-001-Administrator-Training-Record.md b/Forms/Training/FRM-TRN-001-Administrator-Training-Record.md new file mode 100644 index 0000000..9690290 --- /dev/null +++ b/Forms/Training/FRM-TRN-001-Administrator-Training-Record.md @@ -0,0 +1,185 @@ +# Administrator Training Record + +| Form ID | FRM-TRN-001 | +|---------|-------------| +| Form Title | Administrator Training Record | +| Version | 1.0 | +| Effective Date | [DATE] | + +--- + +## Trainee Information + +| Field | Information | +|-------|-------------| +| Name | | +| Employee/Study ID | | +| Department/Site | | +| Job Title/Role | | +| Education Level | | +| Clinical Credentials (if applicable) | | + +## Training Session Information + +| Field | Information | +|-------|-------------| +| Measure Name | | +| Measure Version | | +| Measure Type | ☐ PRO ☐ ClinRO ☐ ObsRO ☐ PerfO | +| Training Date | | +| Training Duration | | +| Training Location | ☐ In-Person ☐ Virtual ☐ Self-Study | +| Training Materials Version | | + +## Trainer Information + +| Field | Information | +|-------|-------------| +| Trainer Name | | +| Trainer Qualifications | | +| Trainer Certification (if required) | | + +## Training Content Covered + +### General Training Topics + +☐ PRO/ClinRO/ObsRO/PerfO concepts and definitions +☐ FDA PRO Guidance principles +☐ Standardized administration techniques +☐ Avoiding interviewer bias and response influence +☐ Handling participant questions appropriately +☐ Missing data minimization strategies +☐ Data quality and integrity requirements +☐ Good Clinical Practice (GCP) principles +☐ Informed consent and research ethics +☐ Privacy and confidentiality (HIPAA) + +### Measure-Specific Topics + +☐ Measure purpose and theoretical construct +☐ Target population and intended use +☐ Item content and response format +☐ Recall period specification +☐ Administration instructions (verbatim) +☐ Timing and scheduling requirements +☐ Scoring procedures and calculations +☐ Score interpretation and clinical meaning +☐ Handling incomplete responses +☐ Common administration errors to avoid +☐ Special considerations for this measure + +### Additional Training (check all that apply) + +☐ Electronic administration (eCOA platform training) +☐ Paper backup procedures +☐ Translation and language-specific considerations +☐ Cultural adaptation considerations +☐ Safety procedures (for PerfO) +☐ Equipment operation (for PerfO) +☐ Inter-rater reliability procedures (for ClinRO) + +## Practical Components Completed + +☐ Review of measure items and instructions +☐ Observation of demonstration administration +☐ Mock administration with standardized participant +☐ Role-play practice with feedback +☐ Video review of administration technique +☐ Inter-rater reliability exercise (for ClinRO) +☐ Scoring practice with sample data +☐ eCOA system navigation practice + +## Knowledge Assessment + +### Written Test + +Test Version: __________ + +Number of Questions: __________ + +Score: __________ / __________ Percentage: __________% + +☐ Pass (≥80%) ☐ Fail (<80%) + +If failed: Remediation plan and retest date: _________________________ + +### Practical Assessment + +☐ Pass - Demonstrated competent administration +☐ Fail - Additional training needed + +Specific areas needing improvement: _________________________________ +________________________________________________________________ +________________________________________________________________ + +## Competency Determination + +☐ **COMPETENT** - May administer measure independently +☐ **NOT YET COMPETENT** - Additional training/supervision required + +Competency achieved on: __________ + +Specific limitations or supervision requirements: _____________________ +________________________________________________________________ + +## Copyright Holder Certification (if applicable) + +Certification Required: ☐ Yes ☐ No + +If Yes: +Certification Program: ___________________________________________ +Certification Number: ___________________________________________ +Certification Date: __________ +Expiration Date: __________ +Certificate on file: ☐ Yes ☐ No + +## Study/Protocol Assignment + +This training qualifies the administrator for the following studies/protocols: + +| Protocol Number | Protocol Title | Principal Investigator | +|----------------|----------------|----------------------| +| | | | +| | | | +| | | | + +## Signatures + +**I certify that I have completed the training described above and understand the requirements for administering this outcome measure. I will follow all procedures as trained and seek guidance when uncertain.** + +Trainee Signature: ______________________ Date: __________ + +**I certify that the trainee named above has successfully completed training and demonstrated competence in administering this outcome measure.** + +Trainer Signature: ______________________ Date: __________ + +**I approve this individual to independently administer this outcome measure in the assigned studies/protocols.** + +Supervisor Signature: ______________________ Date: __________ + +--- + +## Retraining/Recertification Record + +| Date | Reason for Retraining | Trainer | Result | +|------|----------------------|---------|--------| +| | ☐ Measure update ☐ Performance issue ☐ Extended absence ☐ Certification renewal ☐ Other: _____ | | ☐ Pass ☐ Fail | +| | | | | +| | | | | + +--- + +## Distribution + +Original: Personnel Training File +Copy: Study File +Copy: Training Database + +**Record Retention:** Duration of employment + 3 years minimum; per study protocol requirements + +--- + +**Related Documents:** +- SOP-GEN-002: Training and Competence for Measure Administration +- SOP-ADM-001: Clinical Outcome Measure Administration +- FRM-TRN-002: Competency Assessment Form diff --git a/Forms/Validation-Records/FRM-VAL-001-Validation-Study-Protocol.md b/Forms/Validation-Records/FRM-VAL-001-Validation-Study-Protocol.md new file mode 100644 index 0000000..2db1c08 --- /dev/null +++ b/Forms/Validation-Records/FRM-VAL-001-Validation-Study-Protocol.md @@ -0,0 +1,315 @@ +# Psychometric Validation Study Protocol + +| Form ID | FRM-VAL-001 | +|---------|-------------| +| Form Title | Psychometric Validation Study Protocol | +| Version | 1.0 | +| Effective Date | [DATE] | + +--- + +## 1. Study Identification + +| Field | Information | +|-------|-------------| +| Protocol Title | | +| Protocol Number | | +| Protocol Version | | +| Protocol Date | | +| Principal Investigator | | +| Biostatistician | | +| Sponsor | | + +## 2. Outcome Measure Information + +| Field | Information | +|-------|-------------| +| Measure Name | | +| Measure Type | ☐ PRO ☐ ClinRO ☐ ObsRO ☐ PerfO | +| Version/Form | | +| Number of Items | | +| Subscales | | +| Recall Period | | +| Response Format | | +| Copyright Status | | +| License Status | | + +## 3. Background and Rationale + +### 3.1 Construct Being Measured +[Describe the concept or construct the measure assesses] + +________________________________________________________________ +________________________________________________________________ +________________________________________________________________ + +### 3.2 Target Population +[Define the intended respondent population] + +________________________________________________________________ +________________________________________________________________ +________________________________________________________________ + +### 3.3 Intended Use +[Describe how the measure will be used - e.g., clinical trials endpoint, clinical assessment, screening tool] + +________________________________________________________________ +________________________________________________________________ +________________________________________________________________ + +### 3.4 Rationale for Validation Study +[Explain why validation is needed - new measure, new population, new context, etc.] + +________________________________________________________________ +________________________________________________________________ +________________________________________________________________ + +### 3.5 Existing Evidence +[Summarize any existing validation evidence] + +________________________________________________________________ +________________________________________________________________ +________________________________________________________________ + +## 4. Validation Objectives + +### 4.1 Primary Objectives + +☐ Assess reliability + - ☐ Internal consistency + - ☐ Test-retest reliability + - ☐ Inter-rater reliability + +☐ Assess validity + - ☐ Content validity + - ☐ Construct validity (convergent/discriminant) + - ☐ Known-groups validity + - ☐ Criterion validity + +☐ Assess responsiveness + - ☐ Sensitivity to change + - ☐ Minimal clinically important difference (MCID) + +☐ Assess interpretability + - ☐ Score distributions + - ☐ Floor/ceiling effects + - ☐ Clinical cutoffs + +### 4.2 Secondary Objectives + +________________________________________________________________ +________________________________________________________________ + +## 5. Study Design + +| Design Element | Description | +|----------------|-------------| +| Study Type | ☐ Cross-sectional ☐ Longitudinal ☐ Test-retest ☐ Other: _____ | +| Number of Timepoints | | +| Duration of Follow-up | | +| Study Settings | | + +## 6. Study Population + +### 6.1 Inclusion Criteria +1. ___________________________________________________________ +2. ___________________________________________________________ +3. ___________________________________________________________ +4. ___________________________________________________________ + +### 6.2 Exclusion Criteria +1. ___________________________________________________________ +2. ___________________________________________________________ +3. ___________________________________________________________ +4. ___________________________________________________________ + +## 7. Sample Size + +### 7.1 Reliability Analyses + +| Analysis | Minimum N | Target N | Rationale | +|----------|-----------|----------|-----------| +| Internal Consistency | | | | +| Test-Retest | | | | +| Inter-Rater | | | | + +### 7.2 Validity Analyses + +| Analysis | Minimum N | Target N | Rationale | +|----------|-----------|----------|-----------| +| Factor Analysis | | | | +| Known-Groups | | | | +| Convergent Validity | | | | + +### 7.3 Responsiveness Analyses + +| Analysis | Minimum N | Target N | Rationale | +|----------|-----------|----------|-----------| +| Change Over Time | | | | +| MCID Determination | | | | + +## 8. Comparison Measures + +### 8.1 For Construct Validity + +| Measure Name | Construct Assessed | Expected Correlation | Rationale | +|--------------|-------------------|---------------------|-----------| +| | | Convergent (r ≥ 0.50) | | +| | | Discriminant (r < 0.30) | | +| | | | | + +### 8.2 For Criterion Validity + +| Criterion Measure | Type | Expected Agreement | Rationale | +|------------------|------|-------------------|-----------| +| | ☐ Gold Standard ☐ Anchor | | | + +### 8.3 For Responsiveness + +| Anchor Measure | Purpose | Expected Correlation | Rationale | +|----------------|---------|---------------------|-----------| +| | Patient global rating | | | +| | Clinician global rating | | | + +## 9. Data Collection Schedule + +| Timepoint | Window | Measures to Administer | Purpose | +|-----------|--------|------------------------|---------| +| Baseline | | | | +| | | | | +| | | | | + +## 10. Administration Procedures + +### 10.1 Training Requirements +________________________________________________________________ +________________________________________________________________ + +### 10.2 Administration Mode +☐ Self-administered paper +☐ Interviewer-administered +☐ Electronic (eCOA) +☐ Other: _____________________ + +### 10.3 Administration Order +________________________________________________________________ +________________________________________________________________ + +## 11. Statistical Analysis Plan + +### 11.1 Reliability Analyses + +#### Internal Consistency +- Cronbach's alpha (target ≥ 0.70) +- Item-total correlations +- Factor analysis (exploratory or confirmatory) + +#### Test-Retest Reliability +- Intraclass correlation coefficient (target ≥ 0.70) +- Standard error of measurement +- Bland-Altman plots +- Time between assessments: __________ + +#### Inter-Rater Reliability (if applicable) +- ICC or weighted kappa (target ≥ 0.70) +- Percent agreement + +### 11.2 Validity Analyses + +#### Construct Validity +- Convergent validity: Pearson correlations (target r ≥ 0.50) +- Discriminant validity: Pearson correlations (target r < 0.30) +- Confirmatory factor analysis: CFI > 0.90, RMSEA < 0.08 +- Known-groups validity: t-tests or ANOVA with effect sizes + +#### Content Validity (if applicable) +- Qualitative methods +- Sample size: __________ +- Analysis approach: ___________________________________ + +### 11.3 Responsiveness Analyses + +- Effect sizes: Cohen's d, standardized response mean +- Correlation with change in anchors +- ROC analysis for MCID +- Distribution-based methods: 0.5 SD, 1 SEM + +### 11.4 Interpretability Analyses + +- Floor/ceiling effects (>15% at extremes) +- Score distributions (mean, SD, skewness, kurtosis) +- Clinical cutoffs (if applicable) +- Normative data (if applicable) + +### 11.5 Missing Data Handling + +Strategy: ___________________________________________________ +____________________________________________________________ + +### 11.6 Software + +☐ SAS Version: __________ +☐ R Version: __________ +☐ SPSS Version: __________ +☐ Mplus Version: __________ +☐ Other: ________________ + +## 12. Success Criteria + +[Define criteria for considering the measure adequately validated] + +| Measurement Property | Success Criterion | +|---------------------|------------------| +| Internal Consistency | | +| Test-Retest Reliability | | +| Construct Validity | | +| Responsiveness | | + +## 13. Timeline + +| Milestone | Target Date | Responsible | +|-----------|-------------|-------------| +| Protocol finalization | | | +| Ethics approval | | | +| Participant recruitment start | | | +| Baseline data collection complete | | | +| Follow-up data collection complete | | | +| Data analysis complete | | | +| Validation report draft | | | +| Validation report final | | | + +## 14. Ethical Considerations + +| Element | Status/Details | +|---------|----------------| +| IRB/Ethics Committee | | +| IRB Protocol Number | | +| Informed Consent | ☐ Required ☐ Waived | +| HIPAA Authorization | ☐ Required ☐ Not applicable | + +## 15. Data Management + +| Element | Specification | +|---------|--------------| +| Database System | | +| Data Entry Method | ☐ Single ☐ Double | +| Quality Control Procedures | | +| Data Storage Location | | +| Data Retention Period | | + +--- + +## Protocol Signatures + +| Role | Name | Signature | Date | +|------|------|-----------|------| +| Principal Investigator | | | | +| Biostatistician | | | | +| Quality Manager | | | | + +--- + +**Related Documents:** +- SOP-VAL-001: Psychometric Validation of Clinical Outcome Measures +- FRM-VAL-002: Psychometric Validation Report Template +- SOP-DM-001: Data Management for Validation Studies diff --git a/Policies/POL-001-Quality-Policy.md b/Policies/POL-001-Quality-Policy.md new file mode 100644 index 0000000..16d62fc --- /dev/null +++ b/Policies/POL-001-Quality-Policy.md @@ -0,0 +1,104 @@ +# Quality Policy - Clinical Outcome Measures Management + +| Document ID | POL-001 | +|-------------|---------| +| Title | Quality Policy - Clinical Outcome Measures Management | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | + +--- + +## 1. Policy Statement + +[ORGANIZATION NAME] is committed to maintaining the highest standards in clinical outcome measure development, validation, implementation, and data management. We ensure that all patient-reported outcomes (PROs), clinician-reported outcomes (ClinROs), observer-reported outcomes (ObsROs), and performance outcomes (PerfOs) used in our research and clinical programs meet rigorous psychometric standards and regulatory requirements. + +## 2. Quality Objectives + +Our organization commits to: + +1. **Scientific Rigor**: Ensuring all outcome measures demonstrate appropriate reliability, validity, responsiveness, and interpretability +2. **Regulatory Compliance**: Maintaining compliance with FDA PRO Guidance, ICH guidelines, and other applicable regulations +3. **Intellectual Property Protection**: Respecting copyright, licensing requirements, and intellectual property rights for all proprietary measures +4. **Cultural Sensitivity**: Ensuring proper translation and linguistic validation for international use +5. **Data Integrity**: Maintaining accurate scoring, data collection, and outcome assessment procedures +6. **Training Excellence**: Ensuring all personnel are appropriately trained and certified in measure administration +7. **Continuous Improvement**: Regularly reviewing and updating measure selection, validation, and implementation procedures + +## 3. Management Commitment + +Top management demonstrates commitment to clinical outcome measure quality by: + +- Ensuring adequate resources for psychometric validation studies +- Supporting proper licensing and intellectual property management +- Promoting evidence-based measure selection aligned with study objectives +- Ensuring translation and linguistic validation follow ISPOR guidelines +- Maintaining separation between clinical care and research assessments where appropriate +- Supporting training and certification programs for measure administrators +- Ensuring electronic clinical outcome assessment (eCOA) systems meet 21 CFR Part 11 requirements +- Engaging with measure developers, copyright holders, and licensing organizations appropriately +- Reviewing measure performance data and validation evidence regularly + +## 4. Scope + +This policy applies to: +- All clinical outcome measures used in research studies +- Patient-reported, clinician-reported, observer-reported, and performance outcomes +- Psychometric validation activities +- Measure licensing and copyright management +- Translation and linguistic validation projects +- Training and certification of measure administrators +- Electronic and paper-based outcome assessment systems +- Scoring algorithms and data interpretation procedures + +## 5. Key Principles + +### 5.1 Measure Selection +- Select measures with demonstrated psychometric properties appropriate to the study population and objectives +- Consider respondent burden, literacy requirements, and cultural appropriateness +- Document rationale for measure selection with reference to published validation evidence +- Obtain necessary licenses and permissions before use + +### 5.2 Psychometric Validation +- Conduct validation studies following established methodologies (COSMIN, FDA PRO Guidance) +- Document reliability (internal consistency, test-retest, inter-rater) +- Establish validity (content, construct, criterion) +- Assess responsiveness and minimal clinically important difference (MCID) +- Generate normative data or reference values when appropriate + +### 5.3 Licensing & Copyright +- Identify and track all proprietary measures requiring licenses +- Maintain current license agreements and ensure compliance with terms +- Track license renewal dates and usage restrictions +- Document copyright attributions and obtain permissions for modifications +- Manage royalty payments for commercial use + +### 5.4 Translation & Linguistic Validation +- Follow ISPOR principles of good practice for translation and linguistic validation +- Use forward-backward translation methodology +- Conduct cognitive debriefing with target population +- Obtain linguistic validation certificates +- Maintain version control for all language versions + +### 5.5 Training & Certification +- Ensure administrators are trained in measure-specific procedures +- Document training completion and certification status +- Maintain competency through periodic refresher training +- Follow measure developer requirements for administrator qualifications + +## 6. Communication + +This policy shall be: +- Communicated to all personnel involved in outcome measure activities +- Available to study sponsors, regulatory authorities, and other stakeholders as appropriate +- Reviewed annually for continuing suitability +- Updated to reflect changes in regulatory requirements and scientific best practices + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/README.md b/README.md index e9fb9d4..9c5ffc9 100644 --- a/README.md +++ b/README.md @@ -1,3 +1,117 @@ -# measure-repository +# Clinical Measure Repository Quality Management System -This repository contains template documents for implementing a Quality Management System (QMS) specifically designed for **Clinical Outcome Measures** and **Patient-Reported Outcomes (PRO)** repositories. \ No newline at end of file +This repository contains template documents for implementing a Quality Management System (QMS) specifically designed for **Clinical Outcome Measures** and **Patient-Reported Outcomes (PRO)** repositories. + +## 📊 Designed For + +- Clinical Research Organizations managing outcome measures +- Academic Medical Centers with measure development programs +- Healthcare Quality Improvement departments +- Psychometric Validation Teams +- PRO/eCOA Implementation Teams +- Clinical Trial Operations using validated measures +- Registry Programs tracking clinical outcomes +- Health Economics and Outcomes Research (HEOR) groups + +## Repository Structure + +``` +measure-repository/ +├── Policies/ # Quality policies for measure management +├── SOPs/ # Standard Operating Procedures +│ ├── Licensing/ # License agreements & copyright management +│ ├── Validation/ # Psychometric validation procedures +│ ├── Administration/ # Measure administration protocols +│ ├── Translation/ # Translation & linguistic validation +│ ├── Data-Management/ # Data collection, scoring, storage +│ └── General/ # General quality operations +├── Work Instructions/ # Detailed protocols and procedures +├── Forms/ # Record forms and templates +│ ├── License-Tracking/ # License agreements & renewals +│ ├── Validation-Records/ # Validation study documentation +│ ├── Training/ # Administrator training records +│ └── Scoring/ # Scoring algorithms & interpretations +└── Templates/ # Document templates +``` + +## Outcome Measure Types Covered + +- **PRO** - Patient-Reported Outcomes (e.g., SF-36, PROMIS, PHQ-9) +- **ClinRO** - Clinician-Reported Outcomes (e.g., CGI-S, YBOCS) +- **ObsRO** - Observer-Reported Outcomes (caregiver/proxy reports) +- **PerfO** - Performance Outcomes (objective assessments, e.g., 6MWT, cognitive tests) + +## Document Numbering Convention + +- **POL-XXX**: Policies +- **SOP-LIC-XXX**: Licensing SOPs +- **SOP-VAL-XXX**: Validation SOPs +- **SOP-ADM-XXX**: Administration SOPs +- **SOP-TRN-XXX**: Translation SOPs +- **SOP-DM-XXX**: Data Management SOPs +- **SOP-GEN-XXX**: General SOPs +- **WI-XXX**: Work Instructions / Protocols +- **FRM-XXX**: Forms and Records +- **LIC-XXX**: License Agreements/Tracking +- **VAL-XXX**: Validation Reports +- **SCR-XXX**: Scoring Algorithms + +## 🤖 AI-Powered Document Creation + +This template includes **AtomicAI** integration. Create an issue and mention `@atomicai` to: +- Generate SOPs for measure licensing and copyright management +- Create validation study protocols and documentation +- Draft training materials for measure administrators +- Develop scoring algorithms and interpretation guides +- Create translation and linguistic validation procedures +- Generate electronic vs paper administration protocols + +## Getting Started + +1. Create a new repository using this template +2. Customize documents with your organization's information +3. Add your validated measures to appropriate directories +4. Create issues with `@atomicai` to generate new documents +5. Review and approve AI-generated content via Pull Requests + +## Compliance & Best Practices + +These templates support compliance with: +- **FDA PRO Guidance** (2009) - Patient-Reported Outcome Measures +- **FDA BEST Framework** - Biomarkers, EndpointS, and other Tools +- **ICH E9** - Statistical Principles for Clinical Trials +- **ISPOR Guidelines** - Translation and Linguistic Validation +- **COSMIN** - COnsensus-based Standards for the selection of health Measurement INstruments +- **PROMIS** Standards - Patient-Reported Outcomes Measurement Information System +- **21 CFR Part 11** - Electronic Records (for eCOA) +- **HIPAA** - Health Information Privacy +- **GDPR** - Data Protection (international studies) + +## Key Quality Considerations + +### Psychometric Properties +- **Reliability**: Internal consistency, test-retest, inter-rater +- **Validity**: Content, construct, criterion, known-groups +- **Responsiveness**: Ability to detect meaningful change +- **Interpretability**: Minimal clinically important difference (MCID), normative data + +### Licensing & Copyright +- Track proprietary measure licenses and renewals +- Maintain permissions for use, modification, and translation +- Document copyright restrictions and attribution requirements +- Manage royalty agreements for commercial use + +### Translation Management +- Forward-backward translation methodology +- Cultural adaptation and cognitive debriefing +- Linguistic validation certificates +- Version control for multi-language instruments + +### Administration Standards +- Training and certification requirements for administrators +- Paper vs electronic administration equivalence +- Recall period and timing specifications +- Instructions and response option standardization + +--- +*Powered by AtomicQMS - AI-Enhanced Clinical Measure Quality Management* diff --git a/SOPs/Administration/SOP-ADM-001-Measure-Administration.md b/SOPs/Administration/SOP-ADM-001-Measure-Administration.md new file mode 100644 index 0000000..50a702f --- /dev/null +++ b/SOPs/Administration/SOP-ADM-001-Measure-Administration.md @@ -0,0 +1,312 @@ +# Standard Operating Procedure: Clinical Outcome Measure Administration + +| Document ID | SOP-ADM-001 | +|-------------|---------| +| Title | Clinical Outcome Measure Administration | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Clinical Operations | + +--- + +## 1. Purpose + +This procedure establishes standardized requirements for administering clinical outcome measures to ensure data quality, consistency, and validity across all assessments. + +## 2. Scope + +This procedure applies to: +- Patient-Reported Outcomes (PROs) +- Clinician-Reported Outcomes (ClinROs) +- Observer-Reported Outcomes (ObsROs) +- Performance Outcomes (PerfOs) + +Administered in any setting (clinic, home, remote) using paper or electronic formats. + +## 3. Responsibilities + +### 3.1 Study Coordinator/Clinical Research Associate +- Schedule outcome assessments +- Ensure measures are administered according to protocol +- Maintain assessment materials and equipment +- Document completion and data quality + +### 3.2 Measure Administrator +- Complete required training for each measure +- Follow standardized administration procedures +- Respond to participant questions appropriately +- Maintain certification as required + +### 3.3 Quality Assurance +- Monitor administration compliance +- Review assessment data for quality issues +- Provide feedback and retraining as needed + +## 4. Definitions + +| Term | Definition | +|------|------------| +| PRO | Patient-Reported Outcome - Self-reported by patient without interpretation by clinician or observer | +| ClinRO | Clinician-Reported Outcome - Based on clinician observation and professional judgment | +| ObsRO | Observer-Reported Outcome - Based on caregiver/proxy observation without clinical interpretation | +| PerfO | Performance Outcome - Based on standardized task performed by patient (e.g., timed walk test) | +| Recall Period | The timeframe patients consider when responding (e.g., "in the past week") | +| Response Options | The available choices for answering items (e.g., Likert scale, visual analog scale) | +| Missing Data | Items not completed or answered "don't know/not applicable" | + +## 5. Procedure + +### 5.1 Pre-Administration Preparation + +5.1.1. Verify administrator training and certification: + - Review measure-specific training requirements + - Confirm completion in training database + - Check certification expiration dates + - Complete refresher training if needed + +5.1.2. Verify active license for proprietary measures: + - Check License Tracking Database + - Ensure protocol is covered under current license + - Review any license restrictions or requirements + +5.1.3. Gather required materials: + - Current version of measure + - Administration manual/instructions + - Response forms or electronic device + - Scoring materials if immediate scoring required + - Equipment for performance measures + +5.1.4. Review protocol-specific requirements: + - Timing of assessment (visit window) + - Order of measures if multiple assessments + - Special population considerations + - Conditions for assessment (fasting, medication timing, etc.) + +5.1.5. Prepare assessment environment: + - Private, quiet location + - Adequate lighting + - Comfortable seating + - Free from interruptions + +### 5.2 Patient-Reported Outcomes (PRO) Administration + +#### 5.2.1 Self-Administered PROs + +5.2.1.1. Provide standardized introduction: + - Explain purpose of assessment + - Emphasize there are no right or wrong answers + - Clarify that responses are confidential + - Ask participant to complete independently + +5.2.1.2. Provide written or verbal instructions: + - Read recall period carefully + - Indicate how to mark responses + - Complete all items unless instructed otherwise + - Ask questions if anything is unclear + +5.2.1.3. Allow participant to complete independently: + - Remain available for questions + - Do not observe or read over shoulder + - Provide clarification only on instructions, not items + - Do not influence responses + +5.2.1.4. Check for completeness: + - Review for missing items + - Ask participant to complete skipped items if appropriate + - Document reason if items remain incomplete + - Do not query or suggest changes to responses + +#### 5.2.2 Interviewer-Administered PROs + +5.2.2.1. Read standardized introduction script + +5.2.2.2. Read items verbatim: + - Do not paraphrase or explain items + - Repeat item if participant did not hear or understand + - If participant still unclear, document as "unable to understand" + +5.2.2.3. Read response options clearly: + - Present all available response options + - May use response cards for visual reference + - Allow participant to answer in their own words, then map to options + +5.2.2.4. Record responses accurately: + - Mark participant's initial response + - Do not query or seek clarification of responses + - If participant changes answer, record final response + +5.2.2.5. Handle participant questions: + - Questions about instructions: answer clearly + - Questions about item meaning: repeat item only + - Questions about which response to choose: "whatever is most accurate for you" + +### 5.3 Clinician-Reported Outcomes (ClinRO) Administration + +5.3.1. Review available clinical information: + - Recent medical records + - Laboratory/diagnostic results + - Previous ClinRO scores for comparison + +5.3.2. Conduct clinical evaluation: + - Patient interview if required + - Physical examination if required + - Review of symptoms and functional status + +5.3.3. Apply clinical judgment: + - Consider all available information + - Rate according to measure definitions + - Use anchors and examples provided in measure + - Document supporting observations + +5.3.4. Complete independently: + - Do not confer with other raters before rating + - For training/reliability, may compare after independent rating + - Document any disagreements and resolution process + +### 5.4 Observer-Reported Outcomes (ObsRO) Administration + +5.4.1. Verify observer qualifications: + - Appropriate relationship to patient (caregiver, parent, etc.) + - Adequate opportunity to observe relevant behaviors + - Adequate cognitive ability to complete assessment + +5.4.2. Provide observer instructions: + - Base responses on direct observation + - Consider specified recall period + - Answer based on what you have observed, not what you think + +5.4.3. Follow PRO administration procedures (Section 5.2) + +5.4.4. Consider proxy response implications: + - Patient-proxy agreement may vary by domain + - Document observer relationship and contact frequency + - Note if patient unable to self-report and reason + +### 5.5 Performance Outcomes (PerfO) Administration + +5.5.1. Ensure standardized conditions: + - Consistent time of day if performance varies + - Consider effects of medications or meals + - Appropriate rest before assessment + - Safe environment and equipment + +5.5.2. Demonstrate task if required: + - Follow standardized demonstration script + - Ensure participant understands task + - Allow practice trial if permitted + +5.5.3. Administer performance test: + - Use standardized instructions verbatim + - Follow specified timing procedures + - Apply stopping rules if specified + - Ensure safety throughout + +5.5.4. Record performance objectively: + - Time, distance, or other metrics + - Note any deviations from standard administration + - Document reasons for incomplete assessments + +5.5.5. Provide feedback appropriately: + - Follow measure guidelines on feedback + - Generally, do not provide performance results immediately + - Thank participant for effort + +### 5.6 Electronic Administration (eCOA) + +5.6.1. Verify electronic system: + - System is functioning properly + - Correct measure and version loaded + - Appropriate participant ID entered + - Data connection available if required + +5.6.2. Provide device orientation: + - How to read and respond to items + - How to navigate forward/backward if permitted + - How to submit/save responses + - Technical support contact information + +5.6.3. Monitor for technical issues: + - Device malfunction + - Software errors + - Loss of data connection + - Document issues and resolution + +5.6.4. Have paper backup available: + - Use only if electronic system failure + - Document reason for paper administration + - Follow procedures for paper-to-electronic data entry + +### 5.7 Timing and Scheduling + +5.7.1. Adhere to protocol visit windows: + - Schedule within specified timeframe + - Document actual assessment date and time + - If outside window, document reason + +5.7.2. Consider order effects: + - Follow protocol-specified order if required + - For fatigue-sensitive measures, administer early + - Allow breaks between measures if needed + +5.7.3. Avoid contamination: + - PROs before clinical assessments when possible + - Blind PRO responses from clinicians when appropriate + - ClinRO raters blind to other outcomes when required + +### 5.8 Missing Data Management + +5.8.1. Minimize missing data: + - Review for completeness during visit + - Ask participant to complete missed items when appropriate + - Document reason if items not completed + +5.8.2. Acceptable reasons for missing items: + - Item not applicable to participant + - Participant refused to answer + - Participant unable to understand item + - Technical issue prevented response capture + +5.8.3. Unacceptable approaches: + - Administrator answering on behalf of participant + - Coercing responses + - Querying responses to reduce variability + - Imputing responses during administration + +### 5.9 Documentation + +5.9.1. Complete required documentation: + - Assessment completion log + - Deviations from standard administration + - Missing data with reasons + - Technical issues or protocol deviations + - Administrator name and date + +5.9.2. Ensure data quality: + - Verify all required items completed + - Check for logical inconsistencies + - Resolve data queries promptly + - Maintain source documentation + +## 6. Related Documents + +- WI-XXX: Measure-specific work instructions +- FRM-ADM-001: Assessment Completion Log +- FRM-TRN-001: Administrator Training Record +- SOP-DM-001: Data Management +- SOP-LIC-001: License Management + +## 7. References + +- FDA (2009). Guidance for Industry: Patient-Reported Outcome Measures +- Acquadro C, et al. (2008). Incorporating the patient's perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration +- EMA (2005). Reflection Paper on the Regulatory Guidance for the Use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/Data-Management/.gitkeep b/SOPs/Data-Management/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/General/.gitkeep b/SOPs/General/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/General/SOP-GEN-001-Document-Control.md b/SOPs/General/SOP-GEN-001-Document-Control.md new file mode 100644 index 0000000..2710146 --- /dev/null +++ b/SOPs/General/SOP-GEN-001-Document-Control.md @@ -0,0 +1,219 @@ +# Standard Operating Procedure: Document Control + +| Document ID | SOP-GEN-001 | +|-------------|---------| +| Title | Document Control | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Quality Assurance | + +--- + +## 1. Purpose + +To establish a procedure for the creation, review, approval, distribution, and control of documents within the Measure Repository Quality Management System. + +## 2. Scope + +This procedure applies to all controlled documents including: +- Policies +- Standard Operating Procedures (SOPs) +- Work Instructions +- Forms and Templates +- Validation Reports +- License Agreements +- Translation Certificates +- Measure Administration Manuals + +## 3. Responsibilities + +### 3.1 Document Owner +- Responsible for document content and accuracy +- Initiates document creation and revision +- Ensures periodic review is performed +- Reviews validation evidence and updates + +### 3.2 Quality Manager +- Maintains the document control system +- Assigns document numbers +- Manages document distribution +- Archives obsolete documents +- Tracks measure version control + +### 3.3 Approvers +- Review and approve documents before release +- Ensure documents are adequate for intended purpose +- Verify compliance with regulatory requirements (FDA PRO Guidance, ISPOR) + +## 4. Procedure + +### 4.1 Document Creation + +4.1.1. Identify the need for a new document + +4.1.2. Request document number from Quality Manager + +4.1.3. Draft document using appropriate template + +4.1.4. Include all required header information: + - Document ID + - Title + - Revision number + - Effective date + - Author and approver names + - Department + +4.1.5. Submit for review and approval + +### 4.2 Document Review and Approval + +4.2.1. Route document to appropriate reviewers: + - Subject matter experts + - Measure copyright holders (if applicable) + - Regulatory affairs (for validation reports) + - Legal (for license agreements) + +4.2.2. Reviewers provide comments within 5 business days + +4.2.3. Author addresses all comments + +4.2.4. Final approval by designated approver + +4.2.5. Quality Manager releases document + +4.2.6. Distribute to relevant personnel and training system + +### 4.3 Document Numbering + +Documents shall be numbered according to the following convention: + +| Type | Prefix | Example | +|------|--------|---------| +| Policy | POL | POL-001 | +| Licensing SOP | SOP-LIC | SOP-LIC-001 | +| Validation SOP | SOP-VAL | SOP-VAL-001 | +| Administration SOP | SOP-ADM | SOP-ADM-001 | +| Translation SOP | SOP-TRN | SOP-TRN-001 | +| Data Management SOP | SOP-DM | SOP-DM-001 | +| General SOP | SOP-GEN | SOP-GEN-001 | +| Work Instruction | WI | WI-001 | +| Form | FRM | FRM-001 | +| License Document | LIC | LIC-001 | +| Validation Report | VAL | VAL-001 | +| Scoring Algorithm | SCR | SCR-001 | + +### 4.4 Measure Version Control + +4.4.1. Track all versions of clinical outcome measures: + - Original measure version + - Translated versions with language code + - Modified or adapted versions + - Electronic format versions (eCOA) + +4.4.2. Version naming convention: + - [Measure Name]_v[Version]_[Language]_[Date] + - Example: PHQ9_v1.0_EN-US_2024-01-15 + +4.4.3. Maintain version history documentation: + - Changes between versions + - Rationale for modifications + - Validation status of each version + - Copyright holder approval for changes + +### 4.5 Revision Control + +4.5.1. All changes require documented justification + +4.5.2. Changes follow same review/approval process as new documents + +4.5.3. Revision numbering: + - Major revisions: increment whole number (1.0 → 2.0) + - Minor revisions: increment decimal (1.0 → 1.1) + +4.5.4. Revision history maintained in document footer + +4.5.5. For measure revisions, verify: + - Copyright holder approval obtained + - License permits modifications + - Psychometric impact assessed + - Revalidation needs determined + +### 4.6 Document Distribution + +4.6.1. Current versions available in document control system (Git repository) + +4.6.2. Obsolete versions clearly marked and archived in separate branch/folder + +4.6.3. Training on new/revised documents as needed + +4.6.4. Notification sent to all affected personnel + +4.6.5. For measures used in ongoing studies: + - Coordinate version updates with study teams + - Ensure continuity of measurement + - Document version used at each timepoint + +### 4.7 Periodic Review + +4.7.1. Documents reviewed at least every 2 years + +4.7.2. SOPs related to regulatory requirements reviewed when regulations update + +4.7.3. Validation reports reviewed when new evidence published + +4.7.4. License agreements reviewed 90 days before expiration + +4.7.5. Review documented even if no changes made + +4.7.6. Reviews may result in: + - Revision (with documented changes) + - Reaffirmation (no changes needed) + - Retirement (document obsolete) + +### 4.8 Special Considerations for Measure Documents + +#### 4.8.1 Validation Reports +- Archive raw validation data separately +- Link to statistical analysis files +- Maintain in compliance with 21 CFR Part 11 if electronic +- Update when additional validation evidence obtained + +#### 4.8.2 License Agreements +- Store executed agreements securely +- Maintain access log for auditing +- Set expiration reminders (90 and 30 days) +- Coordinate with legal department + +#### 4.8.3 Translation Certificates +- Link to linguistic validation report +- Document copyright holder approval +- Track all language versions +- Maintain translator qualifications + +## 5. Related Documents + +- FRM-GEN-001: Document Change Request Form +- FRM-GEN-002: Document Review Record +- SOP-LIC-001: License Management +- SOP-TRN-001: Translation and Linguistic Validation +- SOP-VAL-001: Psychometric Validation + +## 6. Definitions + +| Term | Definition | +|------|------------| +| Controlled Document | Document managed under document control system with versioning and approval | +| Obsolete | Document no longer valid for use | +| Revision | Updated version of a document | +| Measure Version | Specific iteration of a clinical outcome measure with documented changes | +| Source Document | Original documentation supporting measure development or validation | + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/General/SOP-GEN-002-Training-Competence.md b/SOPs/General/SOP-GEN-002-Training-Competence.md new file mode 100644 index 0000000..1a23974 --- /dev/null +++ b/SOPs/General/SOP-GEN-002-Training-Competence.md @@ -0,0 +1,317 @@ +# Standard Operating Procedure: Training and Competence for Measure Administration + +| Document ID | SOP-GEN-002 | +|-------------|---------| +| Title | Training and Competence for Measure Administration | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Quality Assurance / Training | + +--- + +## 1. Purpose + +To ensure personnel administering clinical outcome measures are competent based on appropriate education, training, skills, and experience, and meet measure-specific certification requirements. + +## 2. Scope + +This procedure applies to: +- All personnel administering outcome measures (PRO, ClinRO, ObsRO, PerfO) +- Research coordinators and clinical research associates +- Clinician raters for ClinRO measures +- Personnel involved in measure scoring and interpretation +- Translation and validation study personnel + +## 3. Responsibilities + +### 3.1 Study Coordinators/Supervisors +- Identify training needs for measure administrators +- Ensure training completed before measure administration +- Evaluate competence of personnel +- Maintain department training records +- Track measure-specific certification expiration dates + +### 3.2 Training Coordinator +- Coordinate training programs and schedules +- Maintain central training database +- Track training compliance and certification status +- Archive training records per regulatory requirements +- Coordinate with measure copyright holders for certified training + +### 3.3 Quality Manager +- Develop QMS-related training curriculum +- Approve training curricula for outcome measures +- Audit training compliance +- Review training effectiveness +- Ensure alignment with FDA PRO Guidance and ISPOR standards + +### 3.4 Measure Administrators +- Complete assigned training before administering measures +- Maintain current qualifications and certifications +- Report training needs to supervisor +- Follow standardized administration procedures +- Participate in competency assessments + +## 4. Procedure + +### 4.1 Training Needs Assessment + +4.1.1. Identify competence requirements for each role: + - Education level (e.g., clinical degree for ClinRO raters) + - Clinical experience requirements + - Prior assessment experience + - Language proficiency for multilingual studies + +4.1.2. Document requirements in job descriptions + +4.1.3. Assess current competence of personnel: + - Review credentials and experience + - Review prior training records + - Identify measure-specific training gaps + +4.1.4. For each measure, determine: + - General administration training needs + - Measure-specific requirements + - Copyright holder certification requirements + - Ongoing competency assessment needs + +### 4.2 Training Curriculum Development + +4.2.1. General Outcome Assessment Training: + - PRO/ClinRO/ObsRO/PerfO concepts + - FDA PRO Guidance principles + - Standardized administration techniques + - Avoiding response bias + - Handling participant questions + - Missing data minimization + - Data quality and integrity + - GCP and research ethics + +4.2.2. Measure-Specific Training: + - Measure purpose and construct + - Items and response format + - Recall period + - Scoring procedures + - Interpretation guidelines + - Common administration errors + - Measure-specific considerations + +4.2.3. Define learning objectives + +4.2.4. Develop training materials: + - Presentations + - Administration manuals + - Video demonstrations + - Practice cases + - Assessment tools + +4.2.5. Identify delivery method: + - Classroom/workshop + - One-on-one training + - Self-study with assessment + - Computer-based training + - Webinar (live or recorded) + - Copyright holder certified training program + +4.2.6. Define assessment criteria: + - Written test (minimum 80% passing) + - Practical demonstration with standardized participants + - Inter-rater reliability assessment for ClinRO + - Supervisor observation and sign-off + +4.2.7. Obtain approval from Quality Manager + +4.2.8. For proprietary measures requiring certification: + - Coordinate with copyright holder + - Use approved training materials only + - Follow certification process as specified + - Maintain certificates on file + +### 4.3 Training Delivery + +4.3.1. Schedule training session allowing adequate preparation time + +4.3.2. Document attendance with sign-in sheet + +4.3.3. Deliver training per approved curriculum + +4.3.4. Provide opportunities for questions and practice + +4.3.5. Assess comprehension through: + - Written knowledge test (minimum 80% passing score) + - Practical demonstration (mock administration) + - Review of videotaped administration (if applicable) + - Inter-rater reliability exercise (for ClinRO) + +4.3.6. Provide immediate feedback on performance + +4.3.7. Remediate and retest if assessment failed + +4.3.8. Issue training completion certificate + +### 4.4 Certification for Proprietary Measures + +4.4.1. For measures requiring copyright holder certification: + - Enroll personnel in approved certification program + - Complete all required training modules + - Pass certification examination + - Obtain certification certificate + - File certificate in personnel training record + - Track certification expiration date + - Schedule recertification before expiration + +4.4.2. For measures with gold standard training: + - Coordinate with measure developer + - Arrange for training (may be remote or in-person) + - Document completion and certification + - Maintain ongoing qualification requirements + +### 4.5 Training Documentation + +4.5.1. Training records shall include: + - Employee name and ID + - Training title and measure name + - Training date and duration + - Trainer name and qualifications + - Training materials version + - Assessment method and results + - Pass/fail determination + - Certification number (if applicable) + - Certification expiration date (if applicable) + - Signatures of trainee and trainer + +4.5.2. Use Form FRM-TRN-001: Administrator Training Record + +4.5.3. Maintain training records in central training database + +4.5.4. Training records accessible for regulatory inspection + +### 4.6 Competency Assessment + +4.6.1. Initial Competency: + - Demonstrated during training + - Supervised administration of first 3-5 assessments + - Review of first completed assessments for quality + +4.6.2. Ongoing Competency: + - Periodic inter-rater reliability checks (for ClinRO) + - Quality review of assessment data + - Observation of administration technique annually + - Refresher training as needed + +4.6.3. Document competency assessments in FRM-TRN-002 + +4.6.4. Address deficiencies immediately: + - Provide additional training + - Increase supervision + - Reassess competency before independent work + +### 4.7 Retraining Requirements + +4.7.1. Retraining is required when: + - New measure version released + - Significant protocol changes affecting administration + - Performance deficiencies identified + - Extended absence from assessment activities (>12 months) + - Certification expires + - Measure administration procedures updated + - Quality issues identified in audit or data review + +4.7.2. Document retraining using same process as initial training + +4.7.3. Update training database and notify study teams + +### 4.8 New Personnel Orientation + +4.8.1. All new personnel shall complete: + 1. Organization orientation + 2. Quality system overview + 3. Research ethics and GCP training + 4. General outcome assessment training + 5. Specific measure training for assigned studies + 6. SOP read and understand for: + - SOP-ADM-001: Measure Administration + - SOP-DM-001: Data Management + - Study-specific protocols + +4.8.2. New personnel checklist completed and filed + +4.8.3. No independent measure administration until all training complete + +### 4.9 Specialized Training + +4.9.1. ClinRO Rater Training: + - Clinical credentials verification + - Detailed review of rating scales and anchors + - Practice with standardized case vignettes + - Inter-rater reliability establishment + - Ongoing drift prevention through regular calibration + +4.9.2. PerfO Administrator Training: + - Safety procedures + - Equipment operation and calibration + - Standardized instructions and demonstration + - Objective measurement techniques + - Emergency procedures + +4.9.3. Translation Study Personnel: + - Translation methodology (ISPOR guidelines) + - Cognitive debriefing techniques + - Cultural sensitivity + - Qualitative data collection + - See SOP-TRN-001 + +4.9.4. Validation Study Personnel: + - Psychometric concepts + - Validation study protocols + - Statistical analysis plan familiarity + - Data collection procedures + - See SOP-VAL-001 + +## 5. Training Records Retention + +5.1. Training records maintained for duration of personnel employment + +5.2. Records retained minimum 3 years after personnel departure + +5.3. Study-specific training records retained with study documentation per protocol requirements + +5.4. Records available for regulatory inspection and audit + +5.5. Electronic records maintained per 21 CFR Part 11 requirements + +## 6. Training Effectiveness Review + +6.1. Annual review of training program effectiveness: + - Training completion rates + - Assessment pass rates + - Competency assessment results + - Data quality metrics + - Audit findings related to training + +6.2. Update training materials based on: + - New regulatory guidance + - Measure updates + - Identified training gaps + - Audit findings + - Technological changes (e.g., eCOA platforms) + +## 7. Related Documents + +- FRM-TRN-001: Administrator Training Record +- FRM-TRN-002: Competency Assessment Form +- FRM-TRN-003: Training Effectiveness Review +- SOP-ADM-001: Clinical Outcome Measure Administration +- SOP-LIC-001: License Management +- SOP-TRN-001: Translation and Linguistic Validation +- SOP-VAL-001: Psychometric Validation + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/Licensing/SOP-LIC-001-License-Management.md b/SOPs/Licensing/SOP-LIC-001-License-Management.md new file mode 100644 index 0000000..8669e19 --- /dev/null +++ b/SOPs/Licensing/SOP-LIC-001-License-Management.md @@ -0,0 +1,189 @@ +# Standard Operating Procedure: License Management for Proprietary Outcome Measures + +| Document ID | SOP-LIC-001 | +|-------------|---------| +| Title | License Management for Proprietary Outcome Measures | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Quality Management | + +--- + +## 1. Purpose + +This procedure establishes requirements for identifying, obtaining, tracking, and maintaining licenses for proprietary clinical outcome measures used in research studies and clinical programs. + +## 2. Scope + +This procedure applies to all proprietary outcome measures requiring licenses or permissions, including: +- Patient-Reported Outcomes (PROs) +- Clinician-Reported Outcomes (ClinROs) +- Observer-Reported Outcomes (ObsROs) +- Performance Outcomes (PerfOs) + +This includes both paper-based and electronic (eCOA) implementations. + +## 3. Responsibilities + +### 3.1 Quality Manager +- Maintain master list of all licensed measures +- Track license renewal dates +- Ensure compliance with license terms +- Coordinate with copyright holders + +### 3.2 Principal Investigator/Project Lead +- Identify measure licensing requirements during study planning +- Ensure appropriate licenses are obtained before study initiation +- Notify Quality Manager of new measures requiring licenses +- Ensure study team compliance with license terms + +### 3.3 Regulatory Affairs +- Review licenses for regulatory submission requirements +- Maintain copies of licenses in regulatory files +- Coordinate permissions for protocol submissions + +## 4. Definitions + +| Term | Definition | +|------|------------| +| Copyright Holder | The individual or organization that owns the intellectual property rights to the measure | +| License Agreement | A legal agreement granting permission to use a copyrighted measure under specified terms | +| Royalty | A fee paid to the copyright holder for commercial use of a measure | +| Attribution | Required citation or acknowledgment of the measure developer and copyright holder | + +## 5. Procedure + +### 5.1 Identifying Licensing Requirements + +5.1.1. During measure selection, research whether the measure is: + - Public domain (no license required) + - Open access with attribution requirements + - Proprietary requiring paid license + - Available through special permission only + +5.1.2. Document the copyright status in Form FRM-LIC-001 (License Requirements Checklist) + +5.1.3. For proprietary measures, identify: + - Copyright holder and contact information + - Available license types (academic, commercial, per-study, unlimited) + - Costs and payment terms + - Restrictions on use, modification, or translation + - Requirements for reporting results + +### 5.2 Obtaining Licenses + +5.2.1. Contact copyright holder at least 8 weeks before planned measure use + +5.2.2. Complete license application providing: + - Study title and protocol number + - Number of participants + - Study sites and locations + - Intended use (research, clinical, commercial) + - Paper vs electronic administration + - Translation requirements + +5.2.3. Review license agreement for: + - Scope of use permissions + - Duration and renewal terms + - Costs and payment schedule + - Restrictions on modifications or translations + - Requirements for result reporting or publication acknowledgment + - Indemnification and liability provisions + +5.2.4. Obtain institutional legal review if required + +5.2.5. Execute license agreement and submit payment + +5.2.6. File executed license in License Tracking System and project files + +### 5.3 Tracking Active Licenses + +5.3.1. Maintain License Tracking Database (Form FRM-LIC-002) containing: + - Measure name and version + - Copyright holder + - License type and number + - Execution date and expiration date + - Covered projects/studies + - Cost and payment status + - Key terms and restrictions + +5.3.2. Set calendar reminders for: + - 90 days before license expiration + - 30 days before license expiration + - License expiration date + +### 5.4 License Renewals + +5.4.1. At 90 days before expiration, assess continued need for measure + +5.4.2. If renewal needed, initiate renewal process: + - Contact copyright holder + - Update project information + - Review any changes to license terms + - Submit renewal payment + - Update License Tracking Database + +5.4.3. If measure no longer needed: + - Document discontinuation date + - Ensure compliance with any post-termination obligations + - Archive license documentation + +### 5.5 Compliance Monitoring + +5.5.1. Quarterly review of License Tracking Database: + - Verify all active measures have current licenses + - Check upcoming renewals + - Confirm payment status + - Review compliance with license terms + +5.5.2. Investigate any identified issues: + - Expired licenses + - Measures used without licenses + - Uses exceeding license scope + - Missing payment records + +5.5.3. Document corrective actions taken + +### 5.6 Special Considerations + +#### 5.6.1 Electronic Administration (eCOA) +- Confirm license permits electronic implementation +- Provide eCOA platform specifications to copyright holder if required +- Obtain approval for any necessary format adaptations +- Document equivalence testing between paper and electronic versions + +#### 5.6.2 Translations +- Confirm whether translations are included in base license +- Obtain linguistic validation certificates from copyright holder +- Follow copyright holder's translation procedures if specified +- See SOP-TRN-001 for translation requirements + +#### 5.6.3 Commercial Use +- Clearly identify commercial vs academic use +- Ensure appropriate commercial license type +- Document royalty calculation and payment terms +- Maintain records for financial audits + +## 6. Related Documents + +- FRM-LIC-001: License Requirements Checklist +- FRM-LIC-002: License Tracking Database +- FRM-LIC-003: License Renewal Request Form +- SOP-TRN-001: Translation and Linguistic Validation +- SOP-VAL-001: Measure Selection and Validation + +## 7. References + +- U.S. Copyright Law (17 U.S.C.) +- Intellectual property policies of individual measure developers +- Institutional intellectual property and contract policies + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/Translation/SOP-TRN-001-Translation-Linguistic-Validation.md b/SOPs/Translation/SOP-TRN-001-Translation-Linguistic-Validation.md new file mode 100644 index 0000000..781a379 --- /dev/null +++ b/SOPs/Translation/SOP-TRN-001-Translation-Linguistic-Validation.md @@ -0,0 +1,333 @@ +# Standard Operating Procedure: Translation and Linguistic Validation of Clinical Outcome Measures + +| Document ID | SOP-TRN-001 | +|-------------|---------| +| Title | Translation and Linguistic Validation of Clinical Outcome Measures | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Outcomes Research | + +--- + +## 1. Purpose + +This procedure establishes requirements for translating and linguistically validating clinical outcome measures to ensure conceptual equivalence across languages and cultures while maintaining psychometric properties. + +## 2. Scope + +This procedure applies to: +- Translation of validated outcome measures into new languages +- Linguistic validation of existing translations +- Cultural adaptation for different regions +- All measure types (PRO, ClinRO, ObsRO, PerfO) + +## 3. Responsibilities + +### 3.1 Translation Project Manager +- Oversee translation process +- Select and manage translation vendors +- Coordinate with copyright holders +- Ensure adherence to ISPOR guidelines +- Maintain translation documentation + +### 3.2 In-Country Coordinator +- Recruit local translators and reviewers +- Arrange cognitive debriefing sessions +- Provide cultural context and guidance +- Review translations for local appropriateness + +### 3.3 Quality Manager +- Review translation methodology +- Ensure documentation completeness +- Verify copyright permissions +- Approve final translated versions + +## 4. Definitions + +| Term | Definition | +|------|------------| +| Source Language | The original language of the measure (typically English) | +| Target Language | The language into which the measure is being translated | +| Forward Translation | Translation from source to target language | +| Backward Translation | Translation from target language back to source language | +| Reconciliation | Process of resolving discrepancies between translations | +| Cognitive Debriefing | Qualitative interviews with target population to assess comprehension | +| Linguistic Validation | Process of ensuring translation maintains conceptual equivalence | +| Conceptual Equivalence | Same meaning and relevance across languages and cultures | + +## 5. Procedure + +### 5.1 Pre-Translation Activities + +5.1.1. Verify translation rights: + - Check license agreement for translation permissions + - Contact copyright holder for authorization + - Determine if official translations already exist + - Document translation approval in FRM-TRN-001 + +5.1.2. Assess target country/region: + - Identify target language and dialect + - Consider cultural differences affecting concepts + - Determine literacy level of target population + - Identify any regional variations needed + +5.1.3. Obtain source materials: + - Current version of source measure + - Administration instructions + - Conceptual framework and item intent + - Previous translation memory if available + - Validation data for reference + +5.1.4. Select translation methodology: + - Standard ISPOR methodology (most common) + - Copyright holder's proprietary process if required + - Other recognized methods (e.g., EORTC, WHO) + +5.1.5. Assemble translation team: + - Forward translators (2 required) + - Backward translator (1 required) + - In-country reviewer + - Native speakers of both languages + - Healthcare/clinical expertise preferred + +### 5.2 Forward Translation + +5.2.1. Conduct independent forward translations: + - Two translators work independently + - Native speakers of target language + - Fluent in source language + - One "informed" (aware of measure purpose) + - One "uninformed" (naive to measure concepts) + +5.2.2. Forward translation guidelines: + - Aim for conceptual rather than literal translation + - Maintain level of language (lay vs technical) + - Preserve recall period and response options + - Note any translation challenges or ambiguities + - Document rationale for translation choices + +5.2.3. Document forward translations in FRM-TRN-002: + - Original item + - Translator 1 version + - Translator 2 version + - Translator notes and rationale + +### 5.3 Reconciliation of Forward Translations + +5.3.1. Convene reconciliation meeting: + - Both forward translators + - In-country reviewer + - Project manager (may be remote) + +5.3.2. Review each item systematically: + - Compare translation versions + - Discuss differences and rationale + - Consider cultural appropriateness + - Select preferred translation or create synthesis + - Reach consensus on single forward translation + +5.3.3. Document reconciliation: + - Final reconciled translation + - Rationale for choices made + - Unresolved issues for further review + - Record in FRM-TRN-002 + +### 5.4 Backward Translation + +5.4.1. Conduct independent backward translation: + - Translator different from forward translators + - Native speaker of source language + - Fluent in target language + - "Uninformed" - not previously exposed to measure + +5.4.2. Translate reconciled version back to source language: + - Translate without seeing original source version + - Note any items difficult to translate back + - Provide literal translation + - Document in FRM-TRN-003 + +5.4.3. Compare backward translation to original: + - Identify discrepancies + - Assess whether differences indicate translation problems + - Consider whether adjustments needed + - Minor wording differences acceptable if concept maintained + +### 5.5 Harmonization Review + +5.5.1. Conduct harmonization meeting: + - Translation team + - Project manager + - Clinical/outcomes expert + - Copyright holder representative if required + +5.5.2. Review backward translation comparison: + - Identify items with poor backward translation + - Discuss whether forward translation needs revision + - Consider alternative translations + - Update forward translation as needed + +5.5.3. Review across measure: + - Ensure consistent terminology throughout + - Check consistency of instructions and response options + - Verify formatting and layout match original + - Finalize translated version + +5.5.4. Document harmonization decisions in FRM-TRN-004 + +### 5.6 Cognitive Debriefing + +5.6.1. Prepare cognitive debriefing protocol: + - Semi-structured interview guide + - Probes for comprehension and interpretation + - Questions about acceptability and relevance + - Typically 5-8 participants from target population + +5.6.2. Recruit appropriate participants: + - Representative of intended respondent population + - Native speakers of target language + - Range of ages, education levels, disease severity + - Geographic diversity if regional dialects exist + +5.6.3. Conduct cognitive debriefing interviews: + - Participant completes measure + - Interview about specific items: + * "What does this question mean to you?" + * "How did you decide on your answer?" + * "Is anything confusing or difficult to understand?" + * "Are any words or phrases unclear?" + - Probe problematic items in depth + - Document participant feedback + +5.6.4. Analyze cognitive debriefing results: + - Identify items with comprehension problems + - Determine whether issues are widespread or isolated + - Assess whether revisions needed + - Document in FRM-TRN-005 + +### 5.7 Translation Revision (if needed) + +5.7.1. If cognitive debriefing identifies problems: + - Convene translation team + - Develop alternative translations for problematic items + - Consider cultural adaptation if needed + - Document rationale for revisions + +5.7.2. Conduct additional cognitive debriefing: + - Test revised items with new participants + - Continue until no significant issues identified + - Typically 5 participants per iteration sufficient + +### 5.8 Proofreading and Finalization + +5.8.1. Independent proofreading: + - Native speaker not involved in translation + - Check spelling, grammar, punctuation + - Verify consistency throughout + - Compare to source for formatting + +5.8.2. Format final translation: + - Match layout of original measure + - Ensure readability (font size, spacing) + - Include all instructions and response options + - Add translation identification (language, version, date) + +5.8.3. Create final translation package: + - Translated measure + - Administration instructions (translated) + - Scoring instructions (if publicly available) + - Translation certificate + - Linguistic validation report + +### 5.9 Copyright Holder Review (if required) + +5.9.1. Submit translation for approval: + - Final translated measure + - Translation methodology documentation + - Linguistic validation report summary + - Cognitive debriefing results + +5.9.2. Address any copyright holder feedback: + - Make required revisions + - Document changes and rationale + - Obtain final approval + +5.9.3. File approval in license documentation + +### 5.10 Translation Documentation + +5.10.1. Compile linguistic validation report: + - Translation methodology used + - Team qualifications + - Forward and backward translation results + - Cognitive debriefing findings + - Revisions made and rationale + - Conclusions regarding conceptual equivalence + +5.10.2. Create translation certificate including: + - Source and target languages + - Measure name and version + - Translation completion date + - Certification that ISPOR guidelines followed + - Signatures of translation team lead and project manager + +5.10.3. Archive all translation documentation: + - All translation versions + - Meeting notes and reconciliation records + - Cognitive debriefing transcripts and summaries + - Linguistic validation report + - Copyright holder correspondence + - File in Translation Database (FRM-TRN-006) + +### 5.11 Cultural Adaptation + +5.11.1. When cultural adaptation needed beyond translation: + - Identify culture-specific concepts requiring adaptation + - Consult with local clinical and cultural experts + - Modify items while maintaining conceptual equivalence + - Consider alternative examples or phrases + - Document all adaptations and justification + +5.11.2. For substantial cultural adaptations: + - Consider conducting psychometric validation + - May require copyright holder approval + - May result in "culturally adapted version" designation + +### 5.12 Electronic Format Considerations + +5.12.1. For eCOA implementations: + - Verify text fits within screen space + - Check for right-to-left language considerations + - Test all navigation and response capture + - Ensure proper character encoding + - Validate against paper version + +5.12.2. Document any format adaptations required + +## 6. Related Documents + +- FRM-TRN-001: Translation Authorization Form +- FRM-TRN-002: Forward Translation Documentation +- FRM-TRN-003: Backward Translation Documentation +- FRM-TRN-004: Harmonization Meeting Notes +- FRM-TRN-005: Cognitive Debriefing Summary +- FRM-TRN-006: Translation Database +- FRM-TRN-007: Translation Certificate Template +- SOP-LIC-001: License Management +- SOP-VAL-002: Cross-Cultural Validation + +## 7. References + +- Wild D, et al. (2005). Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation. Value in Health, 8(2), 94-104 +- Wild D, et al. (2009). Multinational trials - recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: The ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force Report +- FDA (2009). Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims +- Acquadro C, et al. (2008). Literature Review of Methods to Translate Health-Related Quality of Life Questionnaires for Use in Multinational Clinical Trials. Value in Health, 11(3), 509-521 + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/Validation/SOP-VAL-001-Psychometric-Validation.md b/SOPs/Validation/SOP-VAL-001-Psychometric-Validation.md new file mode 100644 index 0000000..f898698 --- /dev/null +++ b/SOPs/Validation/SOP-VAL-001-Psychometric-Validation.md @@ -0,0 +1,259 @@ +# Standard Operating Procedure: Psychometric Validation of Clinical Outcome Measures + +| Document ID | SOP-VAL-001 | +|-------------|---------| +| Title | Psychometric Validation of Clinical Outcome Measures | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Outcomes Research | + +--- + +## 1. Purpose + +This procedure establishes requirements for conducting psychometric validation studies of clinical outcome measures to ensure they demonstrate appropriate measurement properties for their intended use. + +## 2. Scope + +This procedure applies to: +- New outcome measure development +- Validation of existing measures in new populations +- Adaptation of measures for new contexts or modes of administration +- All outcome measure types (PRO, ClinRO, ObsRO, PerfO) + +## 3. Responsibilities + +### 3.1 Principal Investigator/Measure Developer +- Design validation study protocol +- Ensure appropriate statistical expertise +- Review and interpret validation results +- Document validation evidence + +### 3.2 Biostatistician +- Develop statistical analysis plan +- Conduct psychometric analyses +- Generate validation reports +- Advise on sample size and methodology + +### 3.3 Quality Manager +- Review validation protocols for regulatory compliance +- Maintain validation documentation +- Track validation status of all measures + +## 4. Definitions + +| Term | Definition | +|------|------------| +| Reliability | The degree to which a measure is free from measurement error | +| Internal Consistency | The extent to which items within a scale measure the same construct (Cronbach's alpha) | +| Test-Retest Reliability | Consistency of scores when measure is administered to the same individuals at different times | +| Inter-Rater Reliability | Agreement between different raters/observers (for ClinRO, ObsRO) | +| Validity | The degree to which a measure assesses what it purports to measure | +| Content Validity | Evidence that measure items represent all aspects of the construct | +| Construct Validity | Evidence that measure relates to other measures as theoretically expected | +| Criterion Validity | Agreement between measure and a gold standard | +| Responsiveness | Ability to detect meaningful change over time | +| MCID | Minimal Clinically Important Difference - smallest change considered important | +| Floor/Ceiling Effects | Clustering of scores at bottom or top of scale, limiting ability to detect change | + +## 5. Procedure + +### 5.1 Validation Study Planning + +5.1.1. Define validation objectives: + - Target population + - Intended use and context + - Mode of administration (paper, electronic, interview) + - Key measurement properties to evaluate + +5.1.2. Develop validation protocol including: + - Background and rationale + - Study design and timeline + - Participant eligibility criteria + - Sample size justification + - Data collection procedures + - Statistical analysis plan + - Success criteria for validation + +5.1.3. Select comparison measures: + - Established measures of same construct (convergent validity) + - Measures of different constructs (discriminant validity) + - Clinical indicators or gold standards (criterion validity) + +5.1.4. Obtain necessary regulatory approvals (IRB, informed consent) + +5.1.5. Document validation plan in Form FRM-VAL-001 + +### 5.2 Reliability Assessment + +#### 5.2.1 Internal Consistency Reliability + +5.2.1.1. Analyze baseline data from main study sample + +5.2.1.2. Calculate Cronbach's alpha for each scale/subscale + +5.2.1.3. Acceptance criteria: + - Alpha ≥ 0.70 for group comparisons + - Alpha ≥ 0.90 for individual decision-making + - Alpha < 0.95 (if higher, may indicate item redundancy) + +5.2.1.4. Examine item-total correlations (typically ≥ 0.30) + +5.2.1.5. Assess scale dimensionality using factor analysis + +#### 5.2.2 Test-Retest Reliability + +5.2.2.1. Administer measure twice to stable subsample + +5.2.2.2. Time interval: typically 2-14 days + - Short enough that true change is unlikely + - Long enough to prevent memory effects + +5.2.2.3. Calculate intraclass correlation coefficient (ICC) + +5.2.2.4. Acceptance criteria: + - ICC ≥ 0.70 for group comparisons + - ICC ≥ 0.90 for individual decision-making + +5.2.2.5. Calculate standard error of measurement (SEM) + +5.2.2.6. Generate Bland-Altman plots to assess agreement + +#### 5.2.3 Inter-Rater Reliability (for ClinRO, ObsRO) + +5.2.3.1. Have multiple raters assess same participants + +5.2.3.2. Calculate ICC or weighted kappa as appropriate + +5.2.3.3. Acceptance criteria: + - ICC or kappa ≥ 0.70 + +5.2.3.4. Identify sources of disagreement for training improvement + +### 5.3 Validity Assessment + +#### 5.3.1 Content Validity + +5.3.1.1. Conduct qualitative research with target population: + - Concept elicitation interviews + - Cognitive debriefing of items + - Assessment of comprehensibility and relevance + +5.3.1.2. Obtain expert panel review: + - Clinical experts + - Psychometricians + - Patient representatives + +5.3.1.3. Document evidence in content validity report + +5.3.1.4. For FDA submissions, follow FDA PRO Guidance requirements + +#### 5.3.2 Construct Validity + +5.3.2.1. Convergent validity: + - Correlate with established measures of same construct + - Expected correlation: typically r ≥ 0.50-0.70 + +5.3.2.2. Discriminant validity: + - Correlate with measures of different constructs + - Expected correlation: typically r < 0.30 + +5.3.2.3. Known-groups validity: + - Compare scores across groups expected to differ + - Use appropriate statistical tests (t-test, ANOVA) + - Calculate effect sizes (Cohen's d, eta-squared) + +5.3.2.4. Factorial validity: + - Conduct confirmatory factor analysis (CFA) + - Assess model fit (CFI > 0.90, RMSEA < 0.08, SRMR < 0.08) + +#### 5.3.3 Criterion Validity + +5.3.3.1. If gold standard exists, calculate: + - Sensitivity and specificity + - Positive and negative predictive values + - ROC curves and AUC + +### 5.4 Responsiveness Assessment + +5.4.1. Collect data at baseline and follow-up from participants expected to change + +5.4.2. Calculate change scores + +5.4.3. Assess responsiveness using: + - Effect sizes (Cohen's d, standardized response mean) + - Correlation with external indicators of change + - Receiver operating characteristic (ROC) analysis + +5.4.4. Determine Minimal Clinically Important Difference (MCID): + - Anchor-based methods (correlation with patient global ratings) + - Distribution-based methods (0.5 SD, 1 SEM) + - Multiple methods recommended + +### 5.5 Interpretability Assessment + +5.5.1. Assess score distribution: + - Floor effects: >15% scoring at minimum + - Ceiling effects: >15% scoring at maximum + - Skewness and kurtosis + +5.5.2. Develop score interpretation guidelines: + - Clinical cutoff scores + - Severity categories + - Normative data (if appropriate) + +5.5.3. Document MCID and other interpretability anchors + +### 5.6 Validation Report + +5.6.1. Prepare comprehensive validation report including: + - Study objectives and methods + - Participant characteristics + - All psychometric analyses results + - Tables and figures + - Discussion of strengths and limitations + - Conclusions and recommendations for use + +5.6.2. File validation report as Form FRM-VAL-002 + +5.6.3. Update measure status in Validation Tracking Database + +5.6.4. For regulatory submissions, prepare according to FDA guidance + +### 5.7 Ongoing Validation Activities + +5.7.1. Plan for continued evidence generation: + - Validation in additional populations + - Assessment in different contexts or settings + - Cross-cultural validation + - Longitudinal measurement invariance + +5.7.2. Monitor published validation evidence for measures in use + +5.7.3. Review and update validation status annually + +## 6. Related Documents + +- FRM-VAL-001: Validation Study Protocol Template +- FRM-VAL-002: Psychometric Validation Report Template +- FRM-VAL-003: Validation Tracking Database +- SOP-DM-001: Data Management for Validation Studies +- SOP-LIC-001: License Management + +## 7. References + +- FDA (2009). Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims +- Mokkink LB, et al. (2010). The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments. Quality of Life Research, 19(4), 539-549 +- Reeve BB, et al. (2013). ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Quality of Life Research, 22(8), 1889-1905 +- Streiner DL, Norman GR, Cairney J (2015). Health Measurement Scales: A Practical Guide to Their Development and Use (5th ed.). Oxford University Press +- DeVellis RF (2017). Scale Development: Theory and Applications (4th ed.). SAGE Publications + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/Templates/SOP-Template.md b/Templates/SOP-Template.md new file mode 100644 index 0000000..c14e869 --- /dev/null +++ b/Templates/SOP-Template.md @@ -0,0 +1,69 @@ +# Standard Operating Procedure: [Title] + +| Document ID | SOP-XXX | +|-------------|---------| +| Title | [Title] | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | [DEPARTMENT] | + +--- + +## 1. Purpose + +[State the purpose of this procedure] + +## 2. Scope + +[Define the scope and applicability - which measures, which studies, which personnel] + +## 3. Responsibilities + +### 3.1 [Role 1] +- [Responsibility] +- [Responsibility] + +### 3.2 [Role 2] +- [Responsibility] +- [Responsibility] + +## 4. Definitions + +| Term | Definition | +|------|------------| +| PRO | Patient-Reported Outcome - A measurement based on a report that comes directly from the patient | +| ClinRO | Clinician-Reported Outcome - A measurement based on a report from a trained healthcare professional | +| ObsRO | Observer-Reported Outcome - A measurement based on observation by someone other than the patient or healthcare professional | +| PerfO | Performance Outcome - A measurement based on a standardized task actively undertaken by a patient | +| MCID | Minimal Clinically Important Difference - The smallest change in outcome that patients perceive as beneficial | + +## 5. Procedure + +### 5.1 [Section Title] + +[Procedure steps] + +### 5.2 [Section Title] + +[Procedure steps] + +## 6. Related Documents + +- [List related procedures, forms, validation reports, etc.] + +## 7. References + +- FDA (2009). Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims +- FDA-NIH Biomarker Working Group (2016). BEST (Biomarkers, EndpointS, and other Tools) Resource +- ISPOR Task Force (2005). Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes Measures +- [Additional relevant standards, regulations, publications] + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/Work Instructions/WI-001-Template.md b/Work Instructions/WI-001-Template.md new file mode 100644 index 0000000..2e04e27 --- /dev/null +++ b/Work Instructions/WI-001-Template.md @@ -0,0 +1,104 @@ +# Work Instruction: [Title] + +| Document ID | WI-001 | +|-------------|--------| +| Title | [Title] | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | [DEPARTMENT] | + +--- + +## 1. Purpose + +[Describe the purpose of this work instruction - e.g., administration of specific measure, scoring procedure, translation protocol] + +## 2. Scope + +[Define what activities this instruction covers - specific measures, populations, settings] + +## 3. Prerequisites + +### 3.1 Training Requirements +- [Required training courses/certifications] +- [Measure-specific training completion] +- [Administrator qualification criteria] + +### 3.2 Licensing/Permissions +- [Required licenses or permissions] +- [Copyright acknowledgment] +- [Usage restrictions] + +## 4. Equipment/Materials Required + +| Item | Specification | Notes | +|------|---------------|-------| +| [Measure instrument] | [Version/Form] | [Paper or electronic] | +| [Scoring tools] | [Software/Calculator] | [If applicable] | +| | | | + +## 5. Procedure + +### Step 1: [Preparation] +[Detailed instructions for setup, environment, respondent preparation] + +### Step 2: [Administration] +[Step-by-step administration instructions] +- Standardized instructions to be read verbatim +- Response options and recall period +- Handling respondent questions +- Time limits (if applicable) + +### Step 3: [Scoring] +[Scoring algorithm and procedures] +- Calculation methods +- Handling missing data +- Reverse-scored items (if applicable) +- Subscale and total score computation + +### Step 4: [Interpretation] +[How to interpret scores] +- Reference values or normative data +- Clinical cutoffs or thresholds +- Minimal clinically important difference (MCID) + +### Step 5: [Documentation] +[Required documentation and records] + +## 6. Quality Control + +- [Verification steps] +- [Common errors to avoid] +- [Data quality checks] + +## 7. Acceptance Criteria + +[Define what constitutes successful completion] +- Completeness criteria +- Data quality standards +- Acceptable missing data thresholds + +## 8. Records + +| Record | Location | Retention | +|--------|----------|-----------| +| [Completed measure] | [System/location] | [Duration] | +| [Scoring worksheets] | [System/location] | [Duration] | +| [Training documentation] | [System/location] | [Duration] | + +## 9. References + +- [Measure developer's manual] +- [Validation publications] +- [Related SOPs] +- [License agreement] + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] |