Clinical Trial Data Management Plan Template
1. Study Identification
| Study Title |
|
| Protocol Number |
|
| Sponsor |
|
| Principal Investigator |
|
| Version/Date |
|
2. Data Collection
- Data Sources:
- Case Report Forms (CRFs):
- Electronic Data Capture (EDC) System:
- Data Entry Process:
- Data Collection Timeline:
3. Data Handling and Storage
- Data Storage Locations:
- Data Backup Procedures:
- Data Security Measures:
- Access Control:
4. Data Quality Assurance
- Data Cleaning Procedures:
- Data Validation Methods:
- Query Management:
- Monitoring and Auditing:
5. Confidentiality and Privacy
- De-identification/Anonymization Procedures:
- Participant Confidentiality:
6. Data Sharing and Access
- Data Sharing Policy:
- External Data Requests:
- Data Use Agreements:
7. Archiving and Retention
- Archiving Procedures:
- Data Retention Period:
- Destruction Procedures:
8. Roles and Responsibilities
| Role |
Name |
Responsibilities |
| Data Manager |
|
|
| Principal Investigator |
|
|
| Statistician |
|
|
| Others |
|
|
9. Amendments and Version Control
- Amendment Process:
- Version Control Table:
| Version |
Date |
Description of Changes |
|
|
|