Sync template from atomicqms-style deployment

SOPs/General/SOP-001-Document-Control.md

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+# 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] |

SOPs/General/SOP-002-CAPA.md

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+# 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] |

SOPs/General/SOP-003-Training.md

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+# 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] |

SOPs/General/SOP-004-Internal-Audit.md

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+# 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] |

SOPs/General/SOP-005-Management-Review.md

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+# 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] |

SOPs/Protocol-Review/SOP-IRB-001-Protocol-Submission.md

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+# 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] |

SOPs/Safety/.gitkeep

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+# Placeholder