Checklist of possible evaluations to be made to the DMC
From Grant AM et al Issues in data monitoring an interim analysis of trials. 2005 HTA
Evaluation of trial procedures
- Adequacy of record forms to capture the intended data
- procedures and arrangements for data processing and handling
Evaluation of trial data
- General monitoring of the trial
- Date of freeze of the data set
- Patient accrual and description
- Patient exclusions
- Quality of data
- Completeness of follow-up
- Compliance to treatment
Evaluation of interim statistical analysis
- Safety analyses
- Efficacy analyses
Evaluation of trial context
- Interpretation of interim results
- Results from other individual trials
- Meta-analyses
- Liaison with other groups or DMCs
Back to data and safety monitoring.
This document was last updated on March 2009