During a company meeting recently, talk turned to Delegation of Responsibilities (also known as Delegation of Authority, or DOA) logs. It is common practice for investigators to delegate certain study tasks to other members of the study team (coordinators, Physician Assistants, technicians, etc.). As pointed out by the FDA in their 2009 Guidance for Industry: Investigator Responsibilities, “When tasks are delegated by an investigator, the investigator is responsible for providing adequate supervision of those to whom tasks are delegated.” Sites and sponsors often choose to utilize delegation logs as a way to document those assigned responsibilities, although the log itself is not required by the federal regulations.
Topics: Monitors, Delegation Logs, Delegation of Responsibilities, FDA

