6.2 KiB
Standard Operating Procedure: Document Control
| Document ID | SOP-GEN-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 Measure Repository Quality Management System.
2. Scope
This procedure applies to all controlled documents including:
- Policies
- Standard Operating Procedures (SOPs)
- Work Instructions
- Forms and Templates
- Validation Reports
- License Agreements
- Translation Certificates
- Measure Administration Manuals
3. Responsibilities
3.1 Document Owner
- Responsible for document content and accuracy
- Initiates document creation and revision
- Ensures periodic review is performed
- Reviews validation evidence and updates
3.2 Quality Manager
- Maintains the document control system
- Assigns document numbers
- Manages document distribution
- Archives obsolete documents
- Tracks measure version control
3.3 Approvers
- Review and approve documents before release
- Ensure documents are adequate for intended purpose
- Verify compliance with regulatory requirements (FDA PRO Guidance, ISPOR)
4. Procedure
4.1 Document Creation
4.1.1. Identify the need for a new document
4.1.2. Request document number from Quality Manager
4.1.3. Draft document using appropriate template
4.1.4. Include all required header information:
- Document ID
- Title
- Revision number
- Effective date
- Author and approver names
- Department
4.1.5. Submit for review and approval
4.2 Document Review and Approval
4.2.1. Route document to appropriate reviewers:
- Subject matter experts
- Measure copyright holders (if applicable)
- Regulatory affairs (for validation reports)
- Legal (for license agreements)
4.2.2. Reviewers provide comments within 5 business days
4.2.3. Author addresses all comments
4.2.4. Final approval by designated approver
4.2.5. Quality Manager releases document
4.2.6. Distribute to relevant personnel and training system
4.3 Document Numbering
Documents shall be numbered according to the following convention:
| Type | Prefix | Example |
|---|---|---|
| Policy | POL | POL-001 |
| Licensing SOP | SOP-LIC | SOP-LIC-001 |
| Validation SOP | SOP-VAL | SOP-VAL-001 |
| Administration SOP | SOP-ADM | SOP-ADM-001 |
| Translation SOP | SOP-TRN | SOP-TRN-001 |
| Data Management SOP | SOP-DM | SOP-DM-001 |
| General SOP | SOP-GEN | SOP-GEN-001 |
| Work Instruction | WI | WI-001 |
| Form | FRM | FRM-001 |
| License Document | LIC | LIC-001 |
| Validation Report | VAL | VAL-001 |
| Scoring Algorithm | SCR | SCR-001 |
4.4 Measure Version Control
4.4.1. Track all versions of clinical outcome measures:
- Original measure version
- Translated versions with language code
- Modified or adapted versions
- Electronic format versions (eCOA)
4.4.2. Version naming convention:
- [Measure Name]v[Version][Language]_[Date]
- Example: PHQ9_v1.0_EN-US_2024-01-15
4.4.3. Maintain version history documentation:
- Changes between versions
- Rationale for modifications
- Validation status of each version
- Copyright holder approval for changes
4.5 Revision Control
4.5.1. All changes require documented justification
4.5.2. Changes follow same review/approval process as new documents
4.5.3. Revision numbering:
- Major revisions: increment whole number (1.0 → 2.0)
- Minor revisions: increment decimal (1.0 → 1.1)
4.5.4. Revision history maintained in document footer
4.5.5. For measure revisions, verify:
- Copyright holder approval obtained
- License permits modifications
- Psychometric impact assessed
- Revalidation needs determined
4.6 Document Distribution
4.6.1. Current versions available in document control system (Git repository)
4.6.2. Obsolete versions clearly marked and archived in separate branch/folder
4.6.3. Training on new/revised documents as needed
4.6.4. Notification sent to all affected personnel
4.6.5. For measures used in ongoing studies:
- Coordinate version updates with study teams
- Ensure continuity of measurement
- Document version used at each timepoint
4.7 Periodic Review
4.7.1. Documents reviewed at least every 2 years
4.7.2. SOPs related to regulatory requirements reviewed when regulations update
4.7.3. Validation reports reviewed when new evidence published
4.7.4. License agreements reviewed 90 days before expiration
4.7.5. Review documented even if no changes made
4.7.6. Reviews may result in:
- Revision (with documented changes)
- Reaffirmation (no changes needed)
- Retirement (document obsolete)
4.8 Special Considerations for Measure Documents
4.8.1 Validation Reports
- Archive raw validation data separately
- Link to statistical analysis files
- Maintain in compliance with 21 CFR Part 11 if electronic
- Update when additional validation evidence obtained
4.8.2 License Agreements
- Store executed agreements securely
- Maintain access log for auditing
- Set expiration reminders (90 and 30 days)
- Coordinate with legal department
4.8.3 Translation Certificates
- Link to linguistic validation report
- Document copyright holder approval
- Track all language versions
- Maintain translator qualifications
5. Related Documents
- FRM-GEN-001: Document Change Request Form
- FRM-GEN-002: Document Review Record
- SOP-LIC-001: License Management
- SOP-TRN-001: Translation and Linguistic Validation
- SOP-VAL-001: Psychometric Validation
6. Definitions
| Term | Definition |
|---|---|
| Controlled Document | Document managed under document control system with versioning and approval |
| Obsolete | Document no longer valid for use |
| Revision | Updated version of a document |
| Measure Version | Specific iteration of a clinical outcome measure with documented changes |
| Source Document | Original documentation supporting measure development or validation |
Revision History
| Rev | Date | Description | Author |
|---|---|---|---|
| 1.0 | [DATE] | Initial release | [AUTHOR] |