A system for the appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data for conducted(multi-site) clinical trials.The data and safety monitoring functions and oversight of such activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB).

Reference: ori.hhs.gov/education/products/ucla/chapter5/default.htm
Source: NFU - D4LS versie 0.8 van 26-10-2016 
0.1 5/23/17​

Alternatieven en discussie hieronder: