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Compliance In Focus
Posted by Lauren Easley on Tue, Jan 7, 2014

Our Love/Hate Relationship with Delegation Logs

Our Love Hate Relationship with Delegation LogsDuring 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.

During our discussion, we realized that feelings about Delegation logs differed widely.

Some monitors preferred the use of a DOA log. Being somewhat “Type-A,” they appreciated how clear-cut delegation logs make it. For example, it clearly shows that Dr. Smith was added to the study on this date, was delegated these responsibilities, and was removed on this date. It doesn’t get any more straightforward than that! The log captures several necessary regulatory data in one place and clearly delineates delegated functions. It makes it considerably easier to do our job and keep track of who’s on the study. Having the information in one convenient, easy to locate place also makes it easier to spot red flags, such as a non-study team member performing a study task.

Other monitors disagreed, claiming that the logs are too ambiguous. Who all should be added to the log? What is someone’s official start date – when they were trained on the study or approved by the IRB? They argued that delegation logs often create more questions than they resolve. The monitors also questioned their helpfulness, noting instances where they noticed site staff performing activities that had not been delegated to them. The site’s response? Simply adding the delegated task after the fact. Additionally, in a field of high turnover, the log requires constant updating.

Love or hate ‘em? Let us know your thoughts on delegation logs in the comments below.

Photo Credit: yelahneb

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Topics: Monitors, Delegation Logs, Delegation of Responsibilities, FDA


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