diff --git a/.gitea/workflows/atomicai.yml b/.gitea/workflows/atomicai.yml new file mode 100644 index 0000000..25d01ab --- /dev/null +++ b/.gitea/workflows/atomicai.yml @@ -0,0 +1,79 @@ +name: AtomicAI IRB Human Subjects 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 IRB Human Subjects 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 IRB and Human Subjects Research Quality Management. + + ## Your Expertise + - 45 CFR 46 (Common Rule) requirements + - FDA regulations for clinical investigations (21 CFR 50, 56) + - ICH-GCP (Good Clinical Practice) guidelines + - AAHRPP accreditation standards + - IRB submission and review processes + - Informed consent requirements + - Vulnerable populations protections + - Continuing review and reporting + - Protocol deviations and violations + - Adverse event reporting + - Data safety monitoring + - Research billing compliance + + ## Document Creation Guidelines + - Place IRB SOPs in SOPs/IRB/ + - Place Consent Templates in Templates/Consent/ + - Place Submission Forms in Forms/Submission/ + - Place Reporting Forms in Forms/Reporting/ + - Place Training Records in Forms/Training/ + - Place Policies in Policies/ + + ## Numbering Convention + - SOP-IRB-XXX for IRB SOPs + - SOP-CON-XXX for Consent SOPs + - SOP-RPT-XXX for Reporting SOPs + - TPL-XXX for Templates + - POL-XXX for Policies + - FRM-XXX for Forms + + Always create branches and submit changes as Pull Requests for review. + Prioritize participant protection, regulatory compliance, and ethical conduct. + allowed_tools: 'Read,Edit,Grep,Glob,Write' + disallowed_tools: 'Bash,WebSearch' diff --git a/Forms/Audit-Forms/.gitkeep b/Forms/Audit-Forms/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Consent-Templates/.gitkeep b/Forms/Consent-Templates/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/FRM-001-Document-Change-Request.md b/Forms/FRM-001-Document-Change-Request.md new file mode 100644 index 0000000..55c718a --- /dev/null +++ b/Forms/FRM-001-Document-Change-Request.md @@ -0,0 +1,64 @@ +# Document Change Request Form + +| Form ID | FRM-001 | Revision | 1.0 | +|---------|---------|----------|-----| + +--- + +## Section 1: Request Information + +| Field | Entry | +|-------|-------| +| Request Date | | +| Requested By | | +| Department | | + +## Section 2: Document Information + +| Field | Entry | +|-------|-------| +| Document Number | | +| Document Title | | +| Current Revision | | + +## Section 3: Change Description + +### Type of Change +- [ ] New Document +- [ ] Revision to Existing Document +- [ ] Document Obsolescence + +### Description of Change +*(Describe the proposed change in detail)* + + + + +### Reason for Change +*(Explain why this change is needed)* + + + + +## Section 4: Impact Assessment + +### Affected Areas +- [ ] Training Required +- [ ] Other Documents Affected +- [ ] Process Changes Required +- [ ] Validation Impact + +### List Affected Documents + + +## Section 5: Approvals + +| Role | Name | Signature | Date | +|------|------|-----------|------| +| Requester | | | | +| Document Owner | | | | +| Quality Assurance | | | | + +--- + +*Form FRM-001 Rev 1.0* diff --git a/Forms/FRM-003-CAPA-Form.md b/Forms/FRM-003-CAPA-Form.md new file mode 100644 index 0000000..6790a8f --- /dev/null +++ b/Forms/FRM-003-CAPA-Form.md @@ -0,0 +1,91 @@ +# Corrective and Preventive Action (CAPA) Form + +| Form ID | FRM-003 | Revision | 1.0 | +|---------|---------|----------|-----| + +--- + +## Section 1: CAPA Identification + +| Field | Entry | +|-------|-------| +| CAPA Number | | +| Date Initiated | | +| Initiated By | | +| CAPA Owner | | +| Target Closure Date | | + +## Section 2: Classification + +### Type +- [ ] Corrective Action +- [ ] Preventive Action + +### Source +- [ ] Customer Complaint +- [ ] Internal Audit +- [ ] External Audit +- [ ] Process Deviation +- [ ] Nonconforming Product +- [ ] Management Review +- [ ] Other: ____________ + +### Priority +- [ ] Critical (5 business days) +- [ ] Major (15 business days) +- [ ] Minor (30 business days) + +## Section 3: Problem Description + +*(Describe the nonconformity or potential nonconformity)* + + + + +## Section 4: Immediate Containment + +*(Actions taken to contain the immediate impact)* + + + + +## Section 5: Root Cause Investigation + +### Investigation Method Used +- [ ] 5 Whys +- [ ] Fishbone Diagram +- [ ] Fault Tree Analysis +- [ ] Other: ____________ + +### Root Cause Determination + + + + +## Section 6: Corrective/Preventive Actions + +| Action | Responsible | Due Date | Status | +|--------|-------------|----------|--------| +| | | | | +| | | | | +| | | | | + +## Section 7: Effectiveness Verification + +| Criteria | Method | Result | +|----------|--------|--------| +| | | | + +Verification Date: ____________ +Verified By: ____________ + +## Section 8: Closure + +| Role | Name | Signature | Date | +|------|------|-----------|------| +| CAPA Owner | | | | +| Quality Approval | | | | + +--- + +*Form FRM-003 Rev 1.0* diff --git a/Forms/FRM-006-Audit-Checklist.md b/Forms/FRM-006-Audit-Checklist.md new file mode 100644 index 0000000..45bf0b6 --- /dev/null +++ b/Forms/FRM-006-Audit-Checklist.md @@ -0,0 +1,56 @@ +# Internal Audit Checklist + +| Form ID | FRM-006 | Revision | 1.0 | +|---------|---------|----------|-----| + +--- + +## Audit Information + +| Field | Entry | +|-------|-------| +| Audit Number | | +| Audit Date | | +| Area/Process Audited | | +| Lead Auditor | | +| Auditee(s) | | + +--- + +## Checklist Items + +| # | Requirement/Question | Reference | C/NC/NA | Evidence/Notes | +|---|---------------------|-----------|---------|----------------| +| 1 | Are current versions of applicable procedures available? | SOP-001 | | | +| 2 | Are personnel trained on applicable procedures? | SOP-003 | | | +| 3 | Are training records current and complete? | SOP-003 | | | +| 4 | Are records properly maintained and retrievable? | SOP-001 | | | +| 5 | Are nonconformities being documented and addressed? | SOP-002 | | | +| 6 | Are CAPAs being completed on time? | SOP-002 | | | +| 7 | Is equipment calibrated and maintained? | | | | +| 8 | Are process controls being followed? | | | | +| 9 | Are quality objectives being monitored? | | | | +| 10 | | | | | + +**Legend:** C = Conforming, NC = Nonconforming, NA = Not Applicable + +--- + +## Findings Summary + +| Finding # | Type | Description | Clause Reference | +|-----------|------|-------------|------------------| +| | | | | +| | | | | + +--- + +## Auditor Signature + +| Auditor | Signature | Date | +|---------|-----------|------| +| | | | + +--- + +*Form FRM-006 Rev 1.0* diff --git a/Forms/Reporting-Forms/.gitkeep b/Forms/Reporting-Forms/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Review-Checklists/.gitkeep b/Forms/Review-Checklists/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Submission-Forms/.gitkeep b/Forms/Submission-Forms/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Submissions/FRM-IRB-001-Protocol-Submission-Form.md b/Forms/Submissions/FRM-IRB-001-Protocol-Submission-Form.md new file mode 100644 index 0000000..8eada9d --- /dev/null +++ b/Forms/Submissions/FRM-IRB-001-Protocol-Submission-Form.md @@ -0,0 +1,434 @@ +# IRB Protocol Submission Form + +| Form ID | FRM-IRB-001 | Revision | 1.0 | +|---------|-------------|----------|-----| + +--- + +## Section 1: General Information + +### 1.1 Submission Type + +☐ New Protocol +☐ Modification/Amendment to Protocol #: _____________ +☐ Continuing Review for Protocol #: _____________ + +### 1.2 Study Identification + +| Field | Entry | +|-------|-------| +| Protocol Title | | +| Short Title (≤50 characters) | | +| Proposed Start Date | | +| Expected Duration | months | + +### 1.3 Review Category Requested + +☐ Exempt (specify category): _____________ +☐ Expedited (specify category): _____________ +☐ Full Board Review + +--- + +## Section 2: Principal Investigator Information + +| Field | Entry | +|-------|-------| +| Name | | +| Title/Position | | +| Department | | +| Institution | | +| Mailing Address | | +| Phone | | +| Email | | +| Faculty Sponsor (if PI is student) | | + +**Training Certification:** +| Certification | Expiration Date | +|---------------|-----------------| +| CITI Human Subjects | | +| GCP (if applicable) | | +| Other: | | + +--- + +## Section 3: Research Team + +| Name | Role | Department | Training Current? | +|------|------|------------|-------------------| +| | PI | | ☐ Yes | +| | | | ☐ Yes | +| | | | ☐ Yes | +| | | | ☐ Yes | +| | | | ☐ Yes | + +--- + +## Section 4: Funding Information + +### 4.1 Funding Source + +☐ Internally Funded (Department/Institution) +☐ Federal Grant (Agency: _____________) +☐ Industry Sponsored (Sponsor: _____________) +☐ Foundation/Non-Profit (Name: _____________) +☐ Not Funded + +### 4.2 Grant Information (if applicable) + +| Field | Entry | +|-------|-------| +| Grant/Contract Number | | +| Funding Period | | +| Grant Title | | + +--- + +## Section 5: Study Overview + +### 5.1 Purpose and Objectives + +*Briefly describe the purpose of this research and specific aims (250 words max):* + +### 5.2 Background and Rationale + +*Provide scientific background and justification (500 words max):* + +### 5.3 Research Design + +☐ Observational/Non-interventional +☐ Interventional +☐ Clinical Trial +☐ Survey/Questionnaire +☐ Interview/Focus Group +☐ Secondary Data Analysis +☐ Other: _____________ + +--- + +## Section 6: Subject Population + +### 6.1 Target Population + +| Field | Entry | +|-------|-------| +| Minimum Age | | +| Maximum Age | | +| Target Enrollment (this site) | | +| Target Enrollment (total, all sites) | | + +### 6.2 Inclusion Criteria + +*List specific inclusion criteria:* + +1. +2. +3. +4. +5. + +### 6.3 Exclusion Criteria + +*List specific exclusion criteria:* + +1. +2. +3. +4. +5. + +### 6.4 Vulnerable Populations + +*Check all that may be included:* + +☐ None +☐ Children/Minors +☐ Prisoners +☐ Pregnant Women +☐ Cognitively Impaired +☐ Economically Disadvantaged +☐ Educationally Disadvantaged +☐ Students of PI +☐ Employees of PI +☐ Decisionally Impaired +☐ Other: _____________ + +*If vulnerable populations included, describe additional protections:* + +--- + +## Section 7: Recruitment + +### 7.1 Recruitment Methods + +*Check all that apply:* + +☐ Medical records review +☐ Advertising (print, radio, TV) +☐ Internet/Social media +☐ Flyers/Posters +☐ Direct approach in clinic +☐ Telephone +☐ Email +☐ Referral from provider +☐ Community outreach +☐ Other: _____________ + +### 7.2 Recruitment Materials + +*List all recruitment materials attached:* + +| Document Name | Version/Date | +|---------------|--------------| +| | | +| | | +| | | + +--- + +## Section 8: Research Procedures + +### 8.1 Study Procedures + +*Describe all procedures subjects will undergo (include timeline):* + +### 8.2 Duration of Participation + +| Field | Entry | +|-------|-------| +| Number of visits | | +| Duration of each visit | | +| Total participation time | | +| Follow-up duration | | + +### 8.3 Study Location(s) + +| Location | Address | +|----------|---------| +| | | +| | | + +--- + +## Section 9: Drugs, Devices, and Biologics + +### 9.1 Does this study involve drugs, devices, or biologics? + +☐ No → Skip to Section 10 +☐ Yes → Complete below + +### 9.2 Drug Information + +| Field | Entry | +|-------|-------| +| Drug Name | | +| IND Number (or Exemption) | | +| FDA Approval Status | ☐ Approved ☐ Investigational | +| IND Sponsor | | + +### 9.3 Device Information + +| Field | Entry | +|-------|-------| +| Device Name | | +| IDE Number (or Exemption) | | +| FDA Approval Status | ☐ Approved ☐ Investigational ☐ Exempt | +| Device Risk | ☐ Significant Risk ☐ Non-Significant Risk | + +--- + +## Section 10: Risks and Benefits + +### 10.1 Risks + +*Describe all foreseeable risks (physical, psychological, social, economic, legal):* + +| Risk | Likelihood | Severity | Mitigation | +|------|------------|----------|------------| +| | ☐ Low ☐ Med ☐ High | ☐ Low ☐ Med ☐ High | | +| | ☐ Low ☐ Med ☐ High | ☐ Low ☐ Med ☐ High | | +| | ☐ Low ☐ Med ☐ High | ☐ Low ☐ Med ☐ High | | + +### 10.2 Benefits + +*Describe potential benefits:* + +**To subjects:** + +**To others/society:** + +### 10.3 Risk/Benefit Assessment + +*Justify why risks are reasonable in relation to anticipated benefits:* + +--- + +## Section 11: Privacy and Confidentiality + +### 11.1 Identifiable Information Collected + +*Check all that apply:* + +☐ Name +☐ Date of birth +☐ Social Security Number +☐ Medical Record Number +☐ Address +☐ Phone number +☐ Email +☐ Photographs/Video +☐ Audio recordings +☐ IP address +☐ Genetic information +☐ Other: _____________ + +### 11.2 Data Storage and Security + +| Field | Entry | +|-------|-------| +| Storage location | ☐ Paper ☐ Electronic ☐ Both | +| Physical security measures | | +| Electronic security measures | | +| Who will have access to data? | | +| Data retention period | | +| Disposition after study | ☐ Destroy ☐ Archive | + +### 11.3 Data Sharing + +Will data be shared with others outside the research team? +☐ No ☐ Yes (describe): _____________ + +--- + +## Section 12: Informed Consent + +### 12.1 Consent Process + +*Describe how consent will be obtained:* + +☐ Written consent from subject +☐ Written consent from LAR +☐ Oral consent with documentation +☐ Waiver of documentation of consent +☐ Waiver of consent + +### 12.2 Consent Documents + +| Document | Language | Version/Date | +|----------|----------|--------------| +| Consent Form | | | +| Consent Form | | | +| Assent Form | | | +| HIPAA Authorization | | | + +### 12.3 Waivers Requested + +**Waiver of Consent (45 CFR 46.116(f)):** +☐ Not requested +☐ Requested - Justify below: + +**Waiver of Documentation of Consent (45 CFR 46.117(c)):** +☐ Not requested +☐ Requested - Justify below: + +**Waiver of HIPAA Authorization (45 CFR 164.512(i)):** +☐ Not requested +☐ Requested - Justify below: + +--- + +## Section 13: Compensation + +### 13.1 Subject Compensation + +☐ No compensation +☐ Yes → Complete below + +| Visit/Activity | Compensation Amount | +|----------------|---------------------| +| | $ | +| | $ | +| Total possible | $ | + +### 13.2 Payment Method + +☐ Cash ☐ Check ☐ Gift card ☐ Other: _____________ + +--- + +## Section 14: Conflict of Interest + +### 14.1 Financial Interests + +Does any member of the research team have a financial interest in the study sponsor, product, or outcome? + +☐ No +☐ Yes (disclosure attached) + +--- + +## Section 15: Required Attachments Checklist + +| Document | Attached? | +|----------|-----------| +| Research Protocol | ☐ | +| Informed Consent Form(s) | ☐ | +| Assent Form(s) | ☐ or N/A | +| HIPAA Authorization | ☐ or N/A | +| Recruitment Materials | ☐ or N/A | +| Surveys/Questionnaires | ☐ or N/A | +| Training Certificates | ☐ | +| COI Disclosures | ☐ | +| Grant/Funding Documents | ☐ or N/A | +| Investigator Brochure | ☐ or N/A | +| Site Authorization Letters | ☐ or N/A | +| Data Use Agreement | ☐ or N/A | +| Other: _____________ | ☐ | + +--- + +## Section 16: PI Assurance + +By signing below, I certify that: + +- I have read and will comply with all institutional policies and federal regulations +- All information in this application is accurate and complete +- I will obtain IRB approval before initiating any changes +- I will report adverse events and unanticipated problems promptly +- I will ensure all study personnel are appropriately trained +- I take responsibility for the conduct of this research + +| Field | Entry | +|-------|-------| +| PI Signature | | +| Date | | + +--- + +## Section 17: Department Approval (if required) + +| Field | Entry | +|-------|-------| +| Department Chair/Designee | | +| Signature | | +| Date | | + +--- + +## For IRB Use Only + +| Field | Entry | +|-------|-------| +| Date Received | | +| IRB Protocol Number | | +| Review Category Assigned | ☐ Exempt ☐ Expedited ☐ Full Board | +| Primary Reviewer | | +| Secondary Reviewer | | +| Meeting Date (if Full Board) | | +| Action | | +| Approval Date | | +| Expiration Date | | + +--- + +*Form FRM-IRB-001 Rev 1.0 - IRB Protocol Submission Form* diff --git a/Forms/Training/FRM-004-Training-Record.md b/Forms/Training/FRM-004-Training-Record.md new file mode 100644 index 0000000..b66164d --- /dev/null +++ b/Forms/Training/FRM-004-Training-Record.md @@ -0,0 +1,72 @@ +# Training Record Form + +| Form ID | FRM-004 | Revision | 1.0 | +|---------|---------|----------|-----| + +--- + +## Section 1: Employee Information + +| Field | Entry | +|-------|-------| +| Employee Name | | +| Employee ID | | +| Department | | +| Job Title | | + +## Section 2: Training Information + +| Field | Entry | +|-------|-------| +| Training Title | | +| Training Date | | +| Training Duration | | +| Trainer Name | | +| Trainer Qualification | | + +### Training Type +- [ ] Initial Training +- [ ] Retraining +- [ ] Refresher +- [ ] Procedure Update + +### Delivery Method +- [ ] Classroom +- [ ] On-the-Job +- [ ] Self-Study +- [ ] Computer-Based +- [ ] Other: ____________ + +## Section 3: Training Content + +*(List topics covered or attach training materials)* + + + + +## Section 4: Assessment + +### Assessment Method +- [ ] Written Test +- [ ] Practical Demonstration +- [ ] Verbal Assessment +- [ ] Observation + +### Assessment Results + +| Metric | Result | +|--------|--------| +| Score (if applicable) | | +| Pass/Fail | | + +## Section 5: Signatures + +| Role | Name | Signature | Date | +|------|------|-----------|------| +| Trainee | | | | +| Trainer | | | | +| Supervisor | | | | + +--- + +*Form FRM-004 Rev 1.0* diff --git a/Policies/POL-001-Quality-Policy.md b/Policies/POL-001-Quality-Policy.md new file mode 100644 index 0000000..ebd85dd --- /dev/null +++ b/Policies/POL-001-Quality-Policy.md @@ -0,0 +1,57 @@ +# Quality Policy + +| Document ID | POL-001 | +|-------------|---------| +| Title | Quality Policy | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | + +--- + +## 1. Policy Statement + +[ORGANIZATION NAME] is committed to providing products and services that consistently meet customer requirements and applicable regulatory requirements. We strive for continual improvement of our Quality Management System to enhance customer satisfaction. + +## 2. Quality Objectives + +Our organization commits to: + +1. **Customer Focus**: Understanding and meeting customer needs and expectations +2. **Regulatory Compliance**: Maintaining compliance with all applicable regulations and standards +3. **Continuous Improvement**: Continually improving the effectiveness of our QMS +4. **Employee Engagement**: Ensuring all employees understand their role in quality +5. **Risk-Based Thinking**: Identifying and addressing risks and opportunities + +## 3. Management Commitment + +Top management demonstrates commitment to the QMS by: + +- Ensuring the quality policy is appropriate to the organization's purpose +- Ensuring quality objectives are established and compatible with strategic direction +- Ensuring integration of QMS requirements into business processes +- Promoting the use of the process approach and risk-based thinking +- Ensuring resources needed for the QMS are available +- Communicating the importance of effective quality management +- Ensuring the QMS achieves its intended results +- Engaging, directing, and supporting persons to contribute to QMS effectiveness + +## 4. Scope + +This policy applies to all employees, contractors, and processes within the scope of our Quality Management System. + +## 5. Communication + +This policy shall be: +- Communicated and understood within the organization +- Available to relevant interested parties as appropriate +- Reviewed for continuing suitability + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/README.md b/README.md index e8bcd33..e5a743b 100644 --- a/README.md +++ b/README.md @@ -1,3 +1,133 @@ -# irb-human-subjects +# IRB & Human Subjects Research Quality Management System -A comprehensive QMS template designed for Institutional Review Boards, research ethics committees, and human subjects protection programs. \ No newline at end of file +A comprehensive QMS template designed for Institutional Review Boards, research ethics committees, and human subjects protection programs. + +## 📋 Designed For + +- **Institutional Review Boards** - IRB offices and committees +- **Human Research Protection Programs** - HRPP offices +- **Academic Medical Centers** - Research compliance offices +- **Independent IRBs** - Commercial ethics review organizations +- **Research Institutions** - Universities and research centers +- **Clinical Trial Sites** - Investigator-initiated study oversight +- **Federal Agencies** - OHRP, FDA, and regulatory bodies + +## 📋 Regulatory Framework + +This template supports compliance with: + +- **Common Rule (45 CFR 46)** - Federal Policy for the Protection of Human Subjects +- **FDA 21 CFR 50** - Protection of Human Subjects +- **FDA 21 CFR 56** - Institutional Review Boards +- **HIPAA** - Privacy Rule for research +- **ICH-GCP E6(R2)** - Good Clinical Practice +- **OHRP Guidance** - Office for Human Research Protections requirements +- **AAHRPP** - Association for the Accreditation of Human Research Protection Programs +- **Belmont Report** - Ethical Principles for Human Subjects Research +- **Declaration of Helsinki** - International ethical guidelines +- **State Research Regulations** - State-specific requirements + +## Repository Structure + +``` +├── SOPs/ +│ ├── Protocol-Review/ # Initial review, continuing review, amendments +│ ├── Informed-Consent/ # Consent requirements, waivers, documentation +│ ├── Compliance/ # Audits, monitoring, non-compliance +│ ├── Vulnerable-Populations/# Children, prisoners, pregnant women, cognitively impaired +│ ├── Administration/ # Committee management, record retention +│ └── General/ # Document control, training, CAPA +├── Forms/ +│ ├── Submission-Forms/ # New protocol, amendment, continuing review forms +│ ├── Consent-Templates/ # ICF templates, assent forms, waivers +│ ├── Review-Checklists/ # Reviewer worksheets, determination letters +│ ├── Audit-Forms/ # For-cause and routine audit checklists +│ ├── Reporting-Forms/ # Adverse events, deviations, non-compliance +│ └── Training/ # IRB member and researcher training +├── Policies/ # HRPP policies +├── Work-Instructions/ # Step-by-step procedures +└── Templates/ # Document templates +``` + +## Document Numbering Convention + +- **POL-XXX**: Policies +- **SOP-PR-XXX**: Protocol Review SOPs +- **SOP-IC-XXX**: Informed Consent SOPs +- **SOP-CMP-XXX**: Compliance SOPs +- **SOP-VP-XXX**: Vulnerable Populations SOPs +- **SOP-ADM-XXX**: Administration SOPs +- **WI-XXX**: Work Instructions +- **FRM-XXX**: Forms and Records + +## 🤖 AI-Powered Assistance + +This repository includes **AtomicAI**, your IRB QMS assistant. Mention `@atomicai` in any issue or pull request to: + +- Draft protocol review procedures and checklists +- Create informed consent templates +- Generate compliance and audit procedures +- Develop vulnerable population protections +- Create IRB member training materials +- Review documents for OHRP/FDA compliance + +### Example Prompts + +- "@atomicai create an SOP for expedited review criteria and procedures" +- "@atomicai draft an informed consent template per Common Rule requirements" +- "@atomicai write a continuing review procedure for greater-than-minimal-risk studies" +- "@atomicai create an audit checklist for research site monitoring" +- "@atomicai develop a non-compliance investigation procedure" +- "@atomicai create a children's assent form template" + +## Getting Started + +1. **Establish Governance** - Define IRB composition and authority +2. **Customize Review Procedures** - Adapt for your institution's research portfolio +3. **Develop Consent Templates** - Create standard ICF language +4. **Implement Training Program** - IRB member and researcher education +5. **Set Up Audit Program** - Routine and for-cause audit procedures + +## Key Documents to Create First + +1. **Initial Protocol Review SOP** - Full board and expedited procedures +2. **Informed Consent Requirements** - Consent elements and documentation +3. **Continuing Review SOP** - Annual review procedures +4. **Amendment Review SOP** - Modification review process +5. **Adverse Event Reporting SOP** - Unanticipated problem procedures +6. **Non-Compliance Investigation SOP** - Response to violations +7. **Vulnerable Population Policy** - Additional protections + +## Special Considerations for Human Subjects Research + +### Review Procedures +- Criteria for approval (45 CFR 46.111) +- Expedited review categories +- Exempt determinations +- Risk/benefit assessment +- Informed consent review + +### Informed Consent +- Required elements of consent +- Documentation requirements +- Waiver criteria and approvals +- Short form consent procedures +- Electronic consent considerations + +### Vulnerable Populations +- Children (permission and assent) +- Prisoners (additional safeguards) +- Pregnant women and fetuses +- Cognitively impaired individuals +- Economically disadvantaged populations + +### Compliance Monitoring +- Routine protocol audits +- For-cause investigations +- Continuing non-compliance procedures +- Corrective action plans +- Reporting to OHRP/FDA + +--- + +*This template is maintained by AtomicQMS. For questions, open an issue in this repository.* diff --git a/SOPs/Administration/.gitkeep b/SOPs/Administration/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Compliance/.gitkeep b/SOPs/Compliance/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/General/SOP-001-Document-Control.md b/SOPs/General/SOP-001-Document-Control.md new file mode 100644 index 0000000..b64ef52 --- /dev/null +++ b/SOPs/General/SOP-001-Document-Control.md @@ -0,0 +1,112 @@ +# Standard Operating Procedure: Document Control + +| Document ID | SOP-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 Quality Management System. + +## 2. Scope + +This procedure applies to all controlled documents including: +- Policies +- Standard Operating Procedures (SOPs) +- Work Instructions +- Forms and Templates +- Specifications +- External documents of external origin + +## 3. Responsibilities + +### 3.1 Document Owner +- Responsible for document content and accuracy +- Initiates document creation and revision +- Ensures periodic review is performed + +### 3.2 Quality Assurance +- Maintains the document control system +- Assigns document numbers +- Manages document distribution +- Archives obsolete documents + +### 3.3 Approvers +- Review and approve documents before release +- Ensure documents are adequate for intended purpose + +## 4. Procedure + +### 4.1 Document Creation + +1. Identify the need for a new document +2. Request document number from Quality Assurance +3. Draft document using appropriate template +4. Include all required header information +5. Submit for review and approval + +### 4.2 Document Review and Approval + +1. Route document to appropriate reviewers +2. Reviewers provide comments within 5 business days +3. Author addresses all comments +4. Final approval by designated approver +5. Quality Assurance releases document + +### 4.3 Document Numbering + +Documents shall be numbered according to the following convention: + +| Type | Prefix | Example | +|------|--------|---------| +| Policy | POL | POL-001 | +| SOP | SOP | SOP-001 | +| Work Instruction | WI | WI-001 | +| Form | FRM | FRM-001 | + +### 4.4 Revision Control + +1. All changes require documented justification +2. Changes follow same review/approval process as new documents +3. Revision number increments with each approved change +4. Revision history maintained in document footer + +### 4.5 Document Distribution + +1. Current versions available in document control system +2. Obsolete versions marked and archived +3. Training on new/revised documents as needed + +### 4.6 Periodic Review + +1. Documents reviewed at least every 2 years +2. Review documented even if no changes made +3. Reviews may result in revision or reaffirmation + +## 5. Related Documents + +- FRM-001 Document Change Request Form +- FRM-002 Document Review Record + +## 6. Definitions + +| Term | Definition | +|------|------------| +| Controlled Document | Document managed under document control system | +| Obsolete | Document no longer valid for use | +| Revision | Updated version of a document | + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/General/SOP-002-CAPA.md b/SOPs/General/SOP-002-CAPA.md new file mode 100644 index 0000000..8dace85 --- /dev/null +++ b/SOPs/General/SOP-002-CAPA.md @@ -0,0 +1,134 @@ +# Standard Operating Procedure: Corrective and Preventive Action (CAPA) + +| Document ID | SOP-002 | +|-------------|---------| +| Title | Corrective and Preventive Action | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Quality Assurance | + +--- + +## 1. Purpose + +To establish a systematic process for identifying, investigating, correcting, and preventing nonconformities and potential nonconformities. + +## 2. Scope + +This procedure applies to: +- Product and process nonconformities +- Customer complaints +- Audit findings +- Process deviations +- Potential nonconformities identified through risk analysis + +## 3. Definitions + +| Term | Definition | +|------|------------| +| Corrective Action | Action to eliminate the cause of a detected nonconformity | +| Preventive Action | Action to eliminate the cause of a potential nonconformity | +| Root Cause | Fundamental reason for a nonconformity | +| Effectiveness Check | Verification that implemented actions achieved desired results | + +## 4. Responsibilities + +### 4.1 CAPA Owner +- Investigates the issue +- Identifies root cause +- Develops and implements corrective/preventive actions +- Verifies effectiveness + +### 4.2 Quality Assurance +- Manages CAPA system +- Assigns CAPA numbers +- Tracks CAPA status +- Reviews and approves CAPAs +- Reports CAPA metrics to management + +### 4.3 Management +- Provides resources for CAPA implementation +- Reviews CAPA trends +- Ensures timely closure + +## 5. Procedure + +### 5.1 CAPA Initiation + +1. Identify nonconformity or potential nonconformity +2. Document issue on CAPA Form (FRM-003) +3. Classify severity and priority +4. Assign CAPA owner + +### 5.2 Investigation + +1. Gather relevant data and evidence +2. Interview personnel involved +3. Review related documents and records +4. Use appropriate investigation tools: + - 5 Whys + - Fishbone Diagram + - Failure Mode Analysis + +### 5.3 Root Cause Analysis + +1. Identify potential root causes +2. Verify root cause through evidence +3. Document root cause determination +4. Consider systemic implications + +### 5.4 Action Development + +1. Develop corrective/preventive actions +2. Assign responsibilities and due dates +3. Assess actions for: + - Appropriateness to problem severity + - Impact on other processes + - Resource requirements + +### 5.5 Implementation + +1. Execute approved actions +2. Document implementation evidence +3. Update affected documents/processes +4. Provide training as needed + +### 5.6 Effectiveness Verification + +1. Define effectiveness criteria +2. Allow sufficient time for actions to take effect +3. Collect and analyze data +4. Document verification results +5. If ineffective, reopen CAPA for further action + +### 5.7 Closure + +1. Review all CAPA documentation +2. Verify all actions completed +3. Confirm effectiveness verified +4. Obtain approval for closure + +## 6. CAPA Metrics + +Quality Assurance shall track and report: +- Number of open CAPAs +- CAPA aging +- On-time closure rate +- Effectiveness rate +- CAPAs by category/source + +## 7. Related Documents + +- FRM-003 CAPA Form +- SOP-003 Nonconforming Product Control +- SOP-004 Customer Complaints + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/General/SOP-003-Training.md b/SOPs/General/SOP-003-Training.md new file mode 100644 index 0000000..22538c1 --- /dev/null +++ b/SOPs/General/SOP-003-Training.md @@ -0,0 +1,123 @@ +# Standard Operating Procedure: Training and Competence + +| Document ID | SOP-003 | +|-------------|---------| +| Title | Training and Competence | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Human Resources / Quality | + +--- + +## 1. Purpose + +To ensure personnel performing work affecting product quality are competent based on appropriate education, training, skills, and experience. + +## 2. Scope + +This procedure applies to: +- All employees performing quality-affecting activities +- Contractors and temporary personnel +- Personnel requiring GxP training + +## 3. Responsibilities + +### 3.1 Supervisors/Managers +- Identify training needs for their personnel +- Ensure training is completed before performing tasks +- Evaluate competence of personnel +- Maintain department training records + +### 3.2 Human Resources +- Coordinate training programs +- Maintain central training database +- Track training compliance +- Archive training records + +### 3.3 Quality Assurance +- Develop QMS-related training +- Approve training curricula for GxP activities +- Audit training compliance + +### 3.4 Employees +- Complete assigned training on time +- Maintain current qualifications +- Report training needs to supervisor + +## 4. Procedure + +### 4.1 Training Needs Assessment + +1. Identify competence requirements for each role +2. Document requirements in job descriptions +3. Assess current competence of personnel +4. Identify training gaps + +### 4.2 Training Curriculum Development + +1. Define learning objectives +2. Develop training materials +3. Identify delivery method: + - Classroom + - On-the-job + - Self-study + - Computer-based +4. Define assessment criteria +5. Obtain approval from Quality (for GxP training) + +### 4.3 Training Delivery + +1. Schedule training session +2. Document attendance +3. Deliver training per curriculum +4. Assess comprehension through: + - Written test (minimum 80% passing) + - Practical demonstration + - Supervisor observation + +### 4.4 Training Documentation + +Training records shall include: +- Employee name and ID +- Training title and date +- Trainer name and qualifications +- Assessment results +- Signatures + +### 4.5 Retraining Requirements + +Retraining is required when: +- Significant document revisions occur +- Performance deficiencies identified +- Extended absence from job function +- Periodic requalification due + +### 4.6 New Employee Orientation + +All new employees shall complete: +1. Company orientation +2. Quality system overview +3. Job-specific training +4. SOP read and understand for applicable procedures + +## 5. Training Records Retention + +- Training records maintained for duration of employment +- Records retained 3 years after employee departure +- Records available for regulatory inspection + +## 6. Related Documents + +- FRM-004 Training Record Form +- FRM-005 Training Assessment Form +- Job Descriptions + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/General/SOP-004-Internal-Audit.md b/SOPs/General/SOP-004-Internal-Audit.md new file mode 100644 index 0000000..749d6a5 --- /dev/null +++ b/SOPs/General/SOP-004-Internal-Audit.md @@ -0,0 +1,136 @@ +# Standard Operating Procedure: Internal Audit + +| Document ID | SOP-004 | +|-------------|---------| +| Title | Internal Audit | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Quality Assurance | + +--- + +## 1. Purpose + +To establish a systematic approach for conducting internal audits to verify the effectiveness of the Quality Management System. + +## 2. Scope + +This procedure covers: +- QMS process audits +- Compliance audits +- Product audits +- System audits + +## 3. Definitions + +| Term | Definition | +|------|------------| +| Audit | Systematic, independent examination to determine conformance | +| Auditor | Person qualified to perform audits | +| Finding | Observation of conformance or nonconformance | +| Observation | Noted item not rising to level of finding | + +## 4. Responsibilities + +### 4.1 Lead Auditor +- Plans and schedules audits +- Prepares audit checklists +- Conducts audit activities +- Reports audit findings + +### 4.2 Quality Manager +- Maintains audit program +- Qualifies auditors +- Reviews audit reports +- Reports to management + +### 4.3 Auditee +- Provides access to areas/records +- Responds to findings +- Implements corrective actions + +## 5. Procedure + +### 5.1 Annual Audit Schedule + +1. Develop annual audit schedule considering: + - Previous audit results + - Process criticality + - Regulatory requirements + - Changes to processes +2. Ensure all QMS processes audited at least annually +3. Obtain management approval +4. Communicate schedule to affected areas + +### 5.2 Auditor Qualification + +Auditors shall: +- Complete auditor training course +- Conduct at least 2 audits under supervision +- Be independent of area being audited +- Maintain competence through ongoing audits + +### 5.3 Audit Preparation + +1. Review applicable procedures and standards +2. Review previous audit reports +3. Prepare audit checklist +4. Notify auditee of audit scope and schedule +5. Confirm auditor availability + +### 5.4 Conducting the Audit + +1. Hold opening meeting with auditee +2. Execute audit checklist +3. Gather objective evidence: + - Document review + - Personnel interviews + - Process observation +4. Document findings with evidence +5. Classify findings: + - Major Nonconformance + - Minor Nonconformance + - Observation +6. Hold closing meeting + +### 5.5 Audit Reporting + +1. Complete audit report within 5 business days +2. Report shall include: + - Audit scope and criteria + - Personnel interviewed + - Findings with evidence + - Recommendations +3. Distribute report to auditee and management + +### 5.6 Finding Resolution + +1. Auditee responds with corrective action plan within 10 business days +2. Quality reviews and approves plan +3. Auditee implements corrective actions +4. Auditor verifies effectiveness +5. Close finding upon verification + +## 6. Audit Records + +Maintain for 5 years: +- Audit schedules +- Checklists +- Reports +- Corrective action records + +## 7. Related Documents + +- FRM-006 Audit Checklist Template +- FRM-007 Audit Report Template +- SOP-002 CAPA + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/General/SOP-005-Management-Review.md b/SOPs/General/SOP-005-Management-Review.md new file mode 100644 index 0000000..dd82006 --- /dev/null +++ b/SOPs/General/SOP-005-Management-Review.md @@ -0,0 +1,114 @@ +# Standard Operating Procedure: Management Review + +| Document ID | SOP-005 | +|-------------|---------| +| Title | Management Review | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Quality Assurance | + +--- + +## 1. Purpose + +To ensure top management reviews the Quality Management System at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. + +## 2. Scope + +This procedure applies to the periodic management review of the QMS, including all processes and quality objectives. + +## 3. Frequency + +Management reviews shall be conducted: +- At least annually +- More frequently if significant changes occur +- As needed based on quality performance + +## 4. Responsibilities + +### 4.1 Quality Manager +- Prepares management review agenda and materials +- Facilitates the meeting +- Documents meeting minutes and action items +- Tracks completion of action items + +### 4.2 Top Management +- Attends management review meetings +- Reviews QMS performance data +- Makes decisions on QMS improvements +- Allocates resources as needed + +### 4.3 Department Managers +- Provides input data for their areas +- Attends management review +- Implements assigned action items + +## 5. Management Review Inputs + +The following shall be considered: + +### 5.1 Actions from Previous Reviews +- Status of action items +- Effectiveness of implemented actions + +### 5.2 Changes in Context +- Internal changes (organization, resources) +- External changes (regulations, market) + +### 5.3 QMS Performance +- Customer satisfaction and feedback +- Quality objectives achievement +- Process performance metrics +- Nonconformities and corrective actions +- Audit results +- Supplier performance + +### 5.4 Resource Adequacy +- Personnel +- Infrastructure +- Work environment + +### 5.5 Risk and Opportunities +- Risk assessment results +- Effectiveness of risk controls +- New opportunities identified + +### 5.6 Improvement Opportunities +- Process improvements +- Product improvements +- QMS enhancements + +## 6. Management Review Outputs + +Decisions and actions related to: +- Improvement of QMS and processes +- Product improvement +- Resource needs +- Changes to quality policy or objectives + +## 7. Documentation + +### 7.1 Meeting Minutes +- Date and attendees +- Items discussed +- Decisions made +- Action items with owners and due dates + +### 7.2 Record Retention +- Management review records retained for 5 years +- Available for regulatory inspection + +## 8. Related Documents + +- FRM-008 Management Review Agenda Template +- FRM-009 Management Review Minutes Template + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/Informed-Consent/.gitkeep b/SOPs/Informed-Consent/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Protocol-Review/.gitkeep b/SOPs/Protocol-Review/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Protocol-Review/SOP-IRB-001-Protocol-Submission.md b/SOPs/Protocol-Review/SOP-IRB-001-Protocol-Submission.md new file mode 100644 index 0000000..129597c --- /dev/null +++ b/SOPs/Protocol-Review/SOP-IRB-001-Protocol-Submission.md @@ -0,0 +1,288 @@ +# Standard Operating Procedure: IRB Protocol Submission and Review + +| Document ID | SOP-IRB-001 | +|-------------|-------------| +| Title | IRB Protocol Submission and Initial Review Process | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Institutional Review Board | + +--- + +## 1. Purpose + +To establish standardized procedures for the submission, review, and approval of human subjects research protocols in accordance with federal regulations (45 CFR 46, 21 CFR 50/56) and institutional policies. + +## 2. Scope + +This procedure applies to all research involving human subjects requiring IRB review, including: +- Biomedical research +- Behavioral research +- Social science research +- Educational research +- FDA-regulated research (drugs, devices, biologics) +- Exempt, expedited, and full board reviews + +## 3. Responsibilities + +### 3.1 Principal Investigator (PI) +- Prepare and submit complete protocol application +- Ensure research team training compliance +- Respond to IRB stipulations +- Maintain protocol compliance + +### 3.2 IRB Coordinator +- Process submissions for completeness +- Assign review pathway +- Coordinate reviewer assignments +- Track submission timelines +- Communicate decisions + +### 3.3 IRB Chair/Vice Chair +- Conduct expedited reviews +- Prepare agenda for full board +- Sign approval letters +- Address urgent matters + +### 3.4 IRB Members +- Review assigned protocols +- Participate in convened meetings +- Vote on protocol actions +- Maintain confidentiality + +## 4. Definitions + +| Term | Definition | +|------|------------| +| Common Rule | Federal Policy for the Protection of Human Subjects (45 CFR 46) | +| Exempt | Research meeting criteria that does not require ongoing IRB oversight | +| Expedited | Minimal risk research eligible for review outside convened meeting | +| Full Board | Research requiring review at convened IRB meeting | +| Minimal Risk | Risk no greater than encountered in daily life | + +## 5. Procedure + +### 5.1 Pre-Submission Requirements + +Before submission, PI must ensure: +- [ ] All study personnel have completed required training (CITI, GCP) +- [ ] Training certificates uploaded to protocol file +- [ ] Conflict of interest disclosures current +- [ ] Department/division approval obtained (if required) +- [ ] Funding information available +- [ ] Study documents prepared (protocol, consent, recruitment materials) + +### 5.2 Protocol Submission + +#### 5.2.1 Required Application Components + +| Document | Required for All | Notes | +|----------|------------------|-------| +| Protocol application form | ☐ | Complete all sections | +| Research protocol/plan | ☐ | Detailed methods | +| Informed consent form(s) | ☐ | Unless waiver requested | +| Recruitment materials | If applicable | Flyers, scripts, ads | +| Data collection instruments | ☐ | Surveys, questionnaires | +| Investigator brochure | FDA-regulated | Drug/device studies | +| Grant/funding documents | If externally funded | | +| Training documentation | ☐ | All personnel | +| COI disclosures | ☐ | All personnel | +| Site authorization letters | Multi-site | External sites | +| Translations | Non-English | Consent, materials | + +#### 5.2.2 Submission Process +1. Complete application in electronic system +2. Upload all required documents +3. Obtain department approval routing +4. Submit to IRB + +### 5.3 Administrative Review + +IRB staff conducts administrative review within **3 business days**: + +| Check | Action | +|-------|--------| +| Application completeness | Return if incomplete | +| Required documents attached | Request missing items | +| Training current | Verify certificates | +| COI disclosures filed | Confirm compliance | +| Regulatory pathway | Assign review category | + +### 5.4 Review Categories + +#### 5.4.1 Exempt Determination + +Research may qualify for exemption under 45 CFR 46.104 categories: +1. Educational settings research +2. Surveys, interviews, observation (with limitations) +3. Benign behavioral interventions +4. Secondary research with identifiable data +5. Federal program evaluation +6. Taste/food quality studies +7. Storage or maintenance of specimens/data +8. Secondary research for regulatory purposes + +**Process:** +- IRB staff or designated reviewer conducts exemption determination +- Timeline: 5 business days +- Outcome: Exempt letter or escalation to expedited/full review + +#### 5.4.2 Expedited Review + +Eligible for expedited if: +- Minimal risk, AND +- Falls into expedited categories (45 CFR 46.110) + +**Expedited Categories include:** +1. Clinical studies of approved products +2. Collection of blood samples +3. Prospective collection of specimens (non-invasive) +4. Data collection through non-invasive procedures +5. Research on characteristics/behavior +6. Voice, video, image recording for research +7. Study of existing data/specimens +8. Continuing review (specific conditions) +9. Minor changes to approved research + +**Process:** +- Assigned to IRB Chair/Vice Chair or experienced member +- Timeline: 10 business days +- Outcomes: Approve, require modifications, refer to full board + +#### 5.4.3 Full Board Review + +Required when: +- Greater than minimal risk, OR +- Not eligible for expedited categories, OR +- Involves vulnerable populations with complex issues + +**Process:** +- Assigned primary reviewer(s) +- Placed on meeting agenda +- Quorum required for deliberation +- Outcomes: Approve, modifications required, table, disapprove + +### 5.5 Review Criteria + +IRB must determine that all of the following are satisfied: + +| Criterion | Requirement | +|-----------|-------------| +| Risks minimized | Through sound design, existing procedures when possible | +| Risks reasonable | In relation to anticipated benefits | +| Equitable selection | Of subjects, including vulnerable populations | +| Informed consent | Sought and documented appropriately | +| Data safety | Adequate provisions for monitoring | +| Privacy/confidentiality | Adequate protections in place | +| Vulnerable populations | Additional safeguards when appropriate | + +### 5.6 Informed Consent Evaluation + +#### Required Elements of Consent (45 CFR 46.116) +- [ ] Statement that study involves research +- [ ] Explanation of purposes +- [ ] Expected duration of participation +- [ ] Description of procedures +- [ ] Description of reasonably foreseeable risks +- [ ] Description of benefits +- [ ] Alternative procedures or treatments +- [ ] Confidentiality protections +- [ ] Compensation/treatment for injury (if applicable) +- [ ] Contact information +- [ ] Statement that participation is voluntary + +#### Additional Elements (as applicable) +- [ ] Unforeseeable risks +- [ ] Circumstances for termination +- [ ] Additional costs to subject +- [ ] Consequences of withdrawal +- [ ] Significant new findings disclosed +- [ ] Number of subjects +- [ ] Biospecimen commercial use statement +- [ ] Whole genome sequencing statement + +### 5.7 IRB Meeting Procedures + +1. **Quorum Requirements** + - Majority of members + - At least one non-scientist + - Scientific expertise relevant to studies reviewed + +2. **Meeting Process** + - Primary reviewer presents protocol + - Discussion by members + - PI may be invited for questions + - Deliberation (PI excused) + - Vote by show of hands + +3. **Voting Actions** + | Action | Definition | + |--------|------------| + | Approved | Ready to proceed | + | Approved with modifications | Minor changes required (verified by Chair) | + | Tabled | Substantive concerns requiring major revision | + | Disapproved | Criteria not met, does not meet regulatory requirements | + +### 5.8 Post-Review Communication + +1. **Approval Letter** + Includes: + - Approval date + - Expiration date (if applicable) + - Approved documents and versions + - Approval conditions + - Continuing review requirements + +2. **Modifications Required Letter** + - Specific changes requested + - Timeline for response + - Process for resubmission + +3. **Disapproval Letter** + - Reasons for disapproval + - Right to respond/appeal + +### 5.9 Response to Stipulations + +1. PI submits written response addressing each stipulation +2. Revise documents as requested +3. Upload revised materials +4. Chair/reviewer verifies adequacy +5. Final approval issued when complete + +## 6. Timelines + +| Review Type | Target Timeline | +|-------------|-----------------| +| Administrative review | 3 business days | +| Exempt determination | 5 business days | +| Expedited review | 10 business days | +| Full board (to meeting) | Next scheduled meeting | +| Post-meeting stipulations | 10 business days after response | + +## 7. Documentation + +- FRM-IRB-001 Protocol Submission Form +- FRM-IRB-002 Informed Consent Template +- FRM-IRB-003 Reviewer Checklist +- Meeting minutes +- Approval/action letters +- Correspondence log + +## 8. References + +- 45 CFR 46 - Protection of Human Subjects +- 21 CFR 50 - Protection of Human Subjects (FDA) +- 21 CFR 56 - Institutional Review Boards (FDA) +- OHRP Guidance Documents +- ICH E6 Good Clinical Practice + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/Safety/.gitkeep b/SOPs/Safety/.gitkeep new file mode 100644 index 0000000..dcf2c80 --- /dev/null +++ b/SOPs/Safety/.gitkeep @@ -0,0 +1 @@ +# Placeholder diff --git a/SOPs/Vulnerable-Populations/.gitkeep b/SOPs/Vulnerable-Populations/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Templates/SOP-Template.md b/Templates/SOP-Template.md new file mode 100644 index 0000000..2e9f35e --- /dev/null +++ b/Templates/SOP-Template.md @@ -0,0 +1,62 @@ +# 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] + +## 3. Responsibilities + +### 3.1 [Role 1] +- [Responsibility] +- [Responsibility] + +### 3.2 [Role 2] +- [Responsibility] +- [Responsibility] + +## 4. Definitions + +| Term | Definition | +|------|------------| +| | | + +## 5. Procedure + +### 5.1 [Section Title] + +[Procedure steps] + +### 5.2 [Section Title] + +[Procedure steps] + +## 6. Related Documents + +- [List related procedures, forms, etc.] + +## 7. References + +- [External standards, regulations, etc.] + +--- + +## 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..68167f1 --- /dev/null +++ b/Work Instructions/WI-001-Template.md @@ -0,0 +1,68 @@ +# 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] + +## 2. Scope + +[Define what activities this instruction covers] + +## 3. Safety Precautions + +- [List any safety requirements] +- [Personal protective equipment needed] +- [Hazards to be aware of] + +## 4. Equipment/Materials Required + +| Item | Specification | +|------|---------------| +| | | +| | | + +## 5. Procedure + +### Step 1: [Title] +[Detailed instructions] + +### Step 2: [Title] +[Detailed instructions] + +### Step 3: [Title] +[Detailed instructions] + +## 6. Acceptance Criteria + +[Define what constitutes successful completion] + +## 7. Records + +| Record | Location | Retention | +|--------|----------|-----------| +| | | | + +## 8. References + +- [Related SOPs] +- [Specifications] +- [Standards] + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] |