Compliance In Focus

Research sponsors and sites know the importance of implementing Quality Assurance processes for their clinical studies. For safety oversight, what steps can be followed to incorporate Quality Assurance into Data Safety Monitoring Boards, Clinical Events Committees, and Medical Monitoring? Take a look at these four tips:

1. Follow Thoughtful Procedures
2. Gain Consensus and Implement a Charter
3. Maintain Well-Organized Documentation
4. Build Quality Control Steps Into Processes

Researchers agree that the highest standards in clinical research need to be preserved to maintain the public’s confidence in their work, competence, and ethics. With patient safety as a primary consideration, the implementation of safety monitoring is paramount. One means of adding this value to a study is utilizing a Data Safety Monitoring Board (DSMB) and/or a Clinical Events Committee (CEC).

Evaluating patient data to ensure the continued safety of clinical trial subjects is an important part of a sponsor’s responsibility. Sponsors often enlist the help of independent boards to ensure expert oversight and eliminate the potential for bias.

Traditionally, Data Safety Monitoring Boards (DSMBs/DMCs) and Clinical Events Committees (CECs) have been set up to operate independently from each other. They have distinct functions and as such, membership generally does not overlap. However, since the FDA has no explicit regulatory requirement for the establishment of a DSMB/CEC (except in the case of emergency research conducted under 21 CFR 50.24 (a)(7)(iv)), it raises the question as to whether or not it may be feasible or even advantageous to combine their efforts into one safety monitoring board. To explore this option, consider the following Q&A’s:

Not all studies require a data safety monitoring board (DSMB) or a clinical events committee (CEC). But should they be implemented for your study, it’s important to know they are not all created equal. The Data Safety Monitoring Boards (DSMB) review cumulative information from a study and monitor safety oversight with teams of independent physicians and medical professors. Clinical Events Committees (CEC) adjudicate finite sets of adverse events within a study to determine if those events are related to the study or not. While it is critical to understand the primary purposes of a DSMB/CEC, you should also look beyond meeting basic requirements in order to be the most confident in your efforts for patient protection and study results.