ORI Introduction to RCR: Chapter 6. Data Management Practices
Guidelines for Clinical Investigator Involvement in Industy-sponsored Clinical Trials
IV. Trial Data Management
- The industry sponsor and the investigators should have a firm commitment to thorough monitoring of the trial at every step.
- All data collected in the trial should be open to scrutiny by both the investigators and the industry sponsor.
- Clinical investigators should have substantial input into the initial analytic plan and also any subsequent amendments that occur during the trial period.
- When possible, statistical analysis of the data should be conducted by an entity independent of the researchers and the sponsor. For trials using interim analysis, use of an independent entity is particularly important. Decisions to prematurely stop a trial should be based upon predetermined criteria.
- Consideration should be given to the use of an unbiased, blinded “clinical evaluation committee” for trials that involve assessment of potentially subjective endpoints.
- The industry sponsors must share the results of all data analyses with the principal investigators. Selective withholding or incomplete reporting of data analyses to the principal investigators is unacceptable.
- Trial results and data analysis should be shared with the principal investigators as soon as they become available. Delays by the industry sponsors for marketing or related purposes are unacceptable. (PDF)
