Drug and Safety Monitoring
The methodology core supports the design and implementation of data and safety monitoring processes for Multidisciplinary Clinical Research Center (MCRC) clinical trials.
The following services are provided:
- Development and / or review of mechanisms for ensuring the overall integrity of the data
- Development and/or review of mechanisms for the monitoring and reporting of adverse events
- Development and / or review of mechanisms for ensuring confidentiality of the trial data and of participants
- Make recommendations to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Internal Review Board and Primary Investigator concerning continuation or conclusion of the trial
