A written Data Management Plan (DMP) is a critical element in conducting a successful clinical study or trial. The DMP is usually very general during the protocol development stage, but it should become very detailed immediately before study initiation.
A typical DMP provides detailed descriptions of how the following areas will be addressed during the clinical trial:
- CRF Processing – How will completed CRFs be tracked, filed, and handled in the data entry area?
- Data Entry – How will staff be trained? Will data be double entered? How will differences in the data be resolved?
- Validation and Query Generation – Who decides how data will be verified? What documentation is needed? How will programming be tested?
- Query Management – How will queries be tracked? How will queries be resolved? How will the main database be updated?
- Coding – Which questions have open-ended text that needs to be grouped for table presentations? Which questions need to be coded with standard medical terminology and what standard medical terminology should be used?
- Filing – Where will CRFs be filed? Who should have access to the files, and how will access to them be controlled? How many copies of each CRF should be made? How should updated data be recorded on the original forms and on copies of them?
- Audits – What types of audits are useful? How much of the data should be audited? How should auditing results be interpreted? What changes should be made to processes based on the results of an audit?
The ICSSC team can assist you with data management in the following ways:
- Site Visit – The ICSSC can review the data management systems and practices at your site. You will receive a written report summarizing your hardware and software systems and processes, along with recommendations for changes if necessary.
- CRF Review – The ICSSC can review your CRFs and make suggestions on format and content.
- Testing – The ICSSC can test your data collection computer programs and provide an extra layer of validation.
- Multi-Center Coordination – The ICSSC can review your plans for managing data flow between multiple centers, and can help create systems for tracking data transfers, combining data, editing data, and communicating between centers.
View presentations from past ICSSC events for information on Data Management in clinical research.