Sync template from atomicqms-style deployment

Forms/FRM-001-Document-Change-Request.md

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+# 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
+- [ ] IRB/Ethics Committee Approval Required
+- [ ] Informed Consent/Assent Forms Affected
+- [ ] Pediatric Safety Considerations
+- [ ] Age-Appropriateness Review Needed
+
+### List Affected Documents
+
+
+### Impact on Active Pediatric Studies
+*(If applicable, describe impact on ongoing studies)*
+
+
+## Section 5: Approvals
+
+| Role | Name | Signature | Date |
+|------|------|-----------|------|
+| Requester | | | |
+| Document Owner | | | |
+| Quality Assurance | | | |
+| Pediatric Specialist (if applicable) | | | |
+
+---
+
+*Form FRM-001 Rev 1.0*

Forms/FRM-003-CAPA-Form.md

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+# 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/Sponsor Complaint
+- [ ] Internal Audit
+- [ ] External Audit
+- [ ] Sponsor Monitoring
+- [ ] Protocol Deviation/Violation
+- [ ] Adverse Event
+- [ ] IRB/Ethics Committee Finding
+- [ ] Participant/Family Concern
+- [ ] Pediatric Safety Issue
+- [ ] Nonconforming Product
+- [ ] Management Review
+- [ ] Other: ____________
+
+### Priority
+- [ ] Critical - Child Safety Risk (Immediate action required)
+- [ ] Major (5 business days)
+- [ ] Minor (15 business days)
+
+## Section 3: Problem Description
+
+*(Describe the nonconformity or potential nonconformity. For pediatric-related issues, include age group affected, number of participants impacted, and any safety implications.)*
+
+
+
+
+## Section 4: Immediate Containment
+
+*(Actions taken to contain the immediate impact, especially for child safety issues)*
+
+
+
+
+## Section 5: Root Cause Investigation
+
+### Investigation Method Used
+- [ ] 5 Whys
+- [ ] Fishbone Diagram
+- [ ] Fault Tree Analysis
+- [ ] Timeline Analysis
+- [ ] Other: ____________
+
+### Pediatric-Specific Factors Considered
+- [ ] Age-appropriateness of procedures/materials
+- [ ] Developmental considerations
+- [ ] Family communication
+- [ ] Parental permission/child assent process
+- [ ] Pediatric dosing or procedures
+- [ ] Child safety monitoring
+- [ ] N/A
+
+### Root Cause Determination
+
+
+
+
+## Section 6: Corrective/Preventive Actions
+
+| Action | Responsible | Due Date | Status |
+|--------|-------------|----------|--------|
+| | | | |
+| | | | |
+| | | | |
+
+## Section 7: Notifications (if applicable)
+
+- [ ] Principal Investigator notified
+- [ ] Sponsor notified (Date: ______)
+- [ ] IRB/Ethics Committee notified (Date: ______)
+- [ ] FDA or other regulatory authority notified (Date: ______)
+- [ ] Participants/families notified (Date: ______)
+- [ ] DSMB notified (Date: ______)
+
+## Section 8: Effectiveness Verification
+
+| Criteria | Method | Result |
+|----------|--------|--------|
+| | | |
+
+Verification Date: ____________
+Verified By: ____________
+
+## Section 9: Closure
+
+| Role | Name | Signature | Date |
+|------|------|-----------|------|
+| CAPA Owner | | | |
+| Quality Approval | | | |
+| PI Approval (if study-related) | | | |
+
+---
+
+*Form FRM-003 Rev 1.0*

Forms/FRM-004-Training-Record.md

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+# 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
+- [ ] Protocol-Specific Training
+
+### Training Category
+- [ ] Good Clinical Practice (GCP)
+- [ ] Human Subject Protection
+- [ ] Pediatric Research Ethics (45 CFR 46 Subpart D)
+- [ ] Pediatric Safety Requirements (21 CFR 50 Subpart D)
+- [ ] ICH E11 Pediatric Guidelines
+- [ ] Pediatric Assent Process
+- [ ] Parental Permission
+- [ ] Age-Appropriate Communication
+- [ ] Child Development
+- [ ] Child Abuse Recognition and Reporting
+- [ ] Pediatric Procedures/Techniques
+- [ ] Study Protocol Training
+- [ ] Other: ____________
+
+### Delivery Method
+- [ ] Classroom
+- [ ] On-the-Job
+- [ ] Self-Study
+- [ ] Computer-Based
+- [ ] Simulation/Role-Play
+- [ ] Other: ____________
+
+## Section 3: Training Content
+
+*(List topics covered or attach training materials)*
+
+
+
+
+### Pediatric-Specific Content (if applicable)
+- Applicable age groups: [ ] Neonates [ ] Infants [ ] Children [ ] Adolescents
+- Special populations covered: ___________________________
+
+
+## Section 4: Assessment
+
+### Assessment Method
+- [ ] Written Test
+- [ ] Practical Demonstration
+- [ ] Verbal Assessment
+- [ ] Observation
+- [ ] Competency Checklist
+- [ ] Role-Play/Simulation (for assent discussions)
+
+### Assessment Results
+
+| Metric | Result |
+|--------|--------|
+| Score (if applicable) | |
+| Pass/Fail | |
+| Passing Score Required | 80% (or per protocol) |
+
+### Competency Achieved
+- [ ] Yes - Authorized to perform independently
+- [ ] No - Requires additional training/supervision
+
+### Next Retraining Due Date
+
+
+## Section 5: Signatures
+
+| Role | Name | Signature | Date |
+|------|------|-----------|------|
+| Trainee | | | |
+| Trainer | | | |
+| Supervisor | | | |
+
+---
+
+*Form FRM-004 Rev 1.0*

Forms/FRM-006-Audit-Checklist.md

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+# Internal Audit Checklist - Pediatric Clinical Research
+
+| Form ID | FRM-006 | Revision | 1.0 |
+|---------|---------|----------|-----|
+
+---
+
+## Audit Information
+
+| Field | Entry |
+|-------|-------|
+| Audit Number | |
+| Audit Date | |
+| Area/Process Audited | |
+| Study Protocol (if applicable) | |
+| Lead Auditor | |
+| Auditee(s) | |
+
+---
+
+## General QMS 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? | | | |
+
+---
+
+## Pediatric Research-Specific Checklist
+
+| # | Requirement/Question | Reference | C/NC/NA | Evidence/Notes |
+|---|---------------------|-----------|---------|----------------|
+| 10 | Are informed consent forms IRB-approved and current? | 45 CFR 46 | | |
+| 11 | Are assent forms age-appropriate for target population? | 45 CFR 46.408 | | |
+| 12 | Is parental permission properly documented? | 21 CFR 50.55 | | |
+| 13 | Do consent/assent forms include all required elements? | ICH-GCP 4.8 | | |
+| 14 | Are both parent signatures obtained when required? | 45 CFR 46.408(b) | | |
+| 15 | Are assent refusals properly documented and respected? | 45 CFR 46.408(a) | | |
+| 16 | Is study categorized correctly per 45 CFR 46.404-407? | SOP-PED | | |
+| 17 | Are pediatric safety assessments conducted per protocol? | SOP-SAF | | |
+| 18 | Are adverse events assessed with pediatric considerations? | ICH E11 | | |
+| 19 | Are growth/development parameters monitored? | Protocol | | |
+| 20 | Is pediatric dosing calculated and verified correctly? | Protocol | | |
+| 21 | Are age-appropriate study materials being used? | SOP-PED | | |
+| 22 | Are child-friendly facilities/equipment available? | Site SOPs | | |
+| 23 | Is staff trained on pediatric research requirements? | SOP-003 | | |
+| 24 | Are child abuse reporting procedures in place? | State Law | | |
+| 25 | Is family burden minimized per protocol design? | ICH E11 | | |
+| 26 | Are adolescent confidentiality provisions addressed? | HIPAA/State | | |
+| 27 | Is DSMB oversight in place if required? | Protocol | | |
+| 28 | Are protocol deviations reported per requirements? | ICH-GCP | | |
+| 29 | Are serious adverse events reported timely? | 21 CFR 312 | | |
+| 30 | Are eligibility criteria properly assessed (age ranges)? | Protocol | | |
+
+---
+
+## Study-Specific Items (customize per protocol)
+
+| # | Requirement/Question | Reference | C/NC/NA | Evidence/Notes |
+|---|---------------------|-----------|---------|----------------|
+| 31 | | | | |
+| 32 | | | | |
+| 33 | | | | |
+| 34 | | | | |
+| 35 | | | | |
+
+**Legend:** C = Conforming, NC = Nonconforming, NA = Not Applicable
+
+---
+
+## Findings Summary
+
+| Finding # | Type (Critical/Major/Minor) | Description | Regulatory/SOP Reference |
+|-----------|---------------------------|-------------|-------------------------|
+| | | | |
+| | | | |
+| | | | |
+
+---
+
+## Positive Observations
+
+*(Note any exemplary practices or strengths observed)*
+
+
+---
+
+## Auditor Signatures
+
+| Auditor | Signature | Date |
+|---------|-----------|------|
+| Lead Auditor | | |
+| Co-Auditor (if applicable) | | |
+
+---
+
+*Form FRM-006 Rev 1.0*