pediatric-clinical-research/SOPs/SOP-001-Document-Control.md

# 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 Pediatric Clinical Research Quality Management System.

## 2. Scope

This procedure applies to all controlled documents including:
- Policies
- Standard Operating Procedures (SOPs)
- Work Instructions
- Forms and Templates
- Assent and Parental Permission forms
- Study protocols and protocol amendments
- Informed consent/assent documents
- Case Report Forms (CRFs)
- 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
- Ensures pediatric-specific requirements are addressed

### 3.2 Quality Assurance
- Maintains the document control system
- Assigns document numbers
- Manages document distribution
- Archives obsolete documents
- Ensures regulatory compliance

### 3.3 Approvers
- Review and approve documents before release
- Ensure documents are adequate for intended purpose
- Verify pediatric-appropriateness where applicable

### 3.4 Pediatric Research Specialist (where applicable)
- Reviews assent/consent documents for age-appropriateness
- Verifies developmental considerations are addressed
- Ensures compliance with 45 CFR 46 Subpart D and 21 CFR 50 Subpart D

## 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. For pediatric-specific documents:
   - Specify applicable age ranges
   - Include developmental considerations
   - Reference appropriate pediatric regulations
6. Submit for review and approval

### 4.2 Document Review and Approval

1. Route document to appropriate reviewers:
   - Content expert reviewers
   - Quality Assurance
   - Pediatric specialist (for child-specific documents)
   - Regulatory affairs (for regulatory documents)
2. Reviewers provide comments within 5 business days
3. Author addresses all comments
4. For assent/consent documents, ensure:
   - Age-appropriate language and reading level
   - Developmentally appropriate explanations
   - IRB/Ethics Committee requirements met
5. Final approval by designated approver
6. 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 |
| Pediatric SOP | SOP-PED | SOP-PED-001 |
| Clinical SOP | SOP-CL | SOP-CL-001 |
| Regulatory SOP | SOP-REG | SOP-REG-001 |
| Data Management SOP | SOP-DM | SOP-DM-001 |
| Safety SOP | SOP-SAF | SOP-SAF-001 |
| Work Instruction | WI | WI-001 |
| Form | FRM | FRM-001 |
| Assent Form | ASF | ASF-001 |
| Parental Permission Form | PPF | PPF-001 |
| Informed Consent Form | ICF | ICF-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. Major revisions: Change integer (e.g., 1.0 → 2.0)
5. Minor revisions: Change decimal (e.g., 1.0 → 1.1)
6. Revision history maintained in document footer
7. For assent/consent forms:
   - IRB/Ethics Committee re-approval required for substantive changes
   - Version date clearly displayed on forms

### 4.5 Document Distribution

1. Current versions available in electronic document control system
2. Obsolete versions clearly marked "OBSOLETE" and archived
3. Training on new/revised documents as needed
4. For assent/consent documents:
   - Site investigators notified immediately of updates
   - Process for transitioning participants to new versions documented

### 4.6 Periodic Review

1. Documents reviewed at least every 2 years
2. Pediatric-specific documents reviewed annually or when regulations change
3. Review documented even if no changes made
4. Reviews may result in revision or reaffirmation
5. Quality Assurance tracks review due dates

### 4.7 External Documents

1. External documents (regulations, standards) identified and controlled
2. Updates to external documents monitored
3. Impact of updates assessed and communicated

## 5. Special Considerations for Pediatric Documents

### 5.1 Assent and Consent Forms
- Age-appropriate language verified (reading level assessment)
- Visual aids and graphics used where appropriate
- Multiple versions for different age groups as needed
- Parent and child versions clearly distinguished
- Compliance with OHRP and FDA pediatric assent guidance

### 5.2 Study Materials
- Developmental appropriateness assessed
- Child life specialist input obtained where applicable
- Age ranges clearly specified

## 6. Related Documents

- FRM-001 Document Change Request Form
- FRM-002 Document Review Record
- SOP-PED-001 Pediatric Assent Process
- SOP-PED-002 Parental Permission Requirements

## 7. Definitions

| Term | Definition |
|------|------------|
| Controlled Document | Document managed under document control system |
| Obsolete | Document no longer valid for use |
| Revision | Updated version of a document |
| Assent | A child's affirmative agreement to participate in research |
| Parental Permission | Permission obtained from parent(s) or guardian(s) for child's participation |

## 8. References

- 45 CFR 46.116, 46.408 (Assent and Parental Permission)
- 21 CFR 50.55 (Parental Permission)
- ICH-GCP E6(R2) Section 4.8 (Informed Consent)
- OHRP Guidance on Assent and Permission

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## Revision History

| Rev | Date | Description | Author |
|-----|------|-------------|--------|
| 1.0 | [DATE] | Initial release | [AUTHOR] |