Sync template from atomicqms-style deployment

Forms/Training/FRM-TRN-001-Administrator-Training-Record.md

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+# 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