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