National guidance documents provide an outline of research and institute responsibilities, to ensure that all clinical trial information is recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification and that this data management process is conducted in accordance with ethical principles.
Researchers have responsibilities for managing data in clinical trials in accordance with:
The data management life cycle of a trial includes:
- Design and production of the data capture tool (paper or electronic) for collection of participant data
- The design and construction of the database for maintaining the data electronically
- Processing of the data (entry/uploading, cleaning and query management)
- Storage of the data
- Production of the final dataset ready for analysis
- Post project activities – retention/disposal, sharing, re-use and ownership of intellectual property
Download an infographic of the Clinical Trial Data Management Life Cycle.
Good data management practice
Depending on the complexity of the trial (large multi-centre versus small single centre), the data management process will vary. Regardless, all members of the trial team have responsibilities for good data management practices. In accordance with Good Clinical Practice (GCP), the Principal Investigator is responsible for delegating key data management tasks to members of their team who have been appropriately trained.
Institutions should have a data management policy and provide standard operating procedures, supporting guidelines and templates to researchers that promote responsible data management practices. See the Melbourne Health: Data Management in Research Guideline.
Generate a trial-specific Data Management Plan
All clinical trials should have a Data Management Plan (DMP) that describes how data will be collected, processed and stored. Researchers should use a DMP template when developing their trial-specific DMP to generate a comprehensive tool that documents data and its handling from definition, collection and processing to final archival or disposal.
The DMP should be developed before the trial starts and be managed as a controlled document. It should be reviewed at least annually and updated to reflect any change in the data management process.