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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'

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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
### List Affected Documents
## Section 5: Approvals
| Role | Name | Signature | Date |
|------|------|-----------|------|
| Requester | | | |
| Document Owner | | | |
| Quality Assurance | | | |
---
*Form FRM-001 Rev 1.0*

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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 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*

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# 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*

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# 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*

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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
### 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*

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# 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] |

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# 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. 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.*

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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] |

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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] |

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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] |

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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] |

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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] |

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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] |

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# 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] |

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# 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] |