Participant safety is at the core of all clinical trials and one of the most crucial aspects of trial conduct. Safety monitoring during a trial is critical for evaluating and characterizing the associated risk of the drug and for making informed decisions on risk minimization. The purpose of safety monitoring during a drug trial is to verify that the safety, rights and well-being of study participants are protected and the reported medical and safety data of the participants is accurate, complete, verifiable (from source documents) and compliant with the applicable regulatory requirement(s).
CDSA has the competence to support the sponsor/investigators/ researchers on initial and ongoing risk assessment, develop, implement and/or monitor project-specific safety management plan and ensure that processes for safety reporting mandated for research projects are in place and being followed. This includes organization and coordination of DSMB, safety monitoring and other related medical monitoring oversight as required / requested for the respective projects.