Investigator-initiated trials usually have a Data Manager within the Sponsor-Investigator’s central coordinating trial team.
Responsibilities may include:
- Development of the Data Management Plan and any other SOPs or guidelines to ensure data management activities are in accordance with Good Clinical Practice (GCP) and any other applicable regulations or local requirements
- Coordinate the design, build, test and validation of the Case Report Form (CRF) or clinical database
- Coordinate process for integrating other systems for Electronic Data Capture (EDC)
- Develop CRF Completion Guidelines for participating sites
- Assign database user permissions in accordance with PI approval
- Enter data from paper CRFs into database
- Perform data cleaning, resolve data queries
- Generate datasets for interim analysis (if applicable) or reporting and final analysis (after database lock)
- Archive trial data at end of trial
See Data Management, for further information about activities.