We may call them “site inspections”, but it’s not the site that’s being inspected when a regulator visits; it’s the Principle Investigator. Though a PI typically delegates study tasks to other staff members, he or she remains solely responsible for the conduct of the study. In fact, the ICH E6(R2) addendum adds two new sections to the international guidance that emphasize PI supervision.

That’s what makes the Delegation of Authority (DoA) log so important and why regulatory inspectors care about it so much. A DoA log serves as evidence that a PI has assigned study tasks only to those staff members with the education, training, and experience to carry them out. If delegates are unqualified to perform their tasks, subject safety could be at risk and it’s highly likely that the study data would be unusable.

Monitors – you can really make a big contribution here. At the outset of the study, you can verify that your PI has made appropriate delegations and the DoA log is complete. You can cross-match the log with training records, CVs, licenses, and source documents and correct any problems as early in the study as possible. Then, throughout the study, you can verify that the DoA log is being maintained.

Coverage

Without referencing any other site document, monitors can spot two types of DoA log omissions.

  1. Missing Assignments. Are there study tasks to which no one has been delegated? The tasks in a DoA log are often represented by a short code to conserve space. A legend at the end of the log translates the code into its corresponding task. Monitors can compare the legend to the DoA log entries to see if any tasks are omitted.
  2. Gap in Assignments. Due to staff turnover, reassignment, leaves of absence, etc., delegation for a task frequently does not last the duration of the entire study. A column in the DoA log indicates the delegation start and stop date.Monitors can check to make sure that when the delegation for a task ends for one staff member, it is picked up by another.

Qualifications

Once you’re satisfied the DoA log completely covers all tasks for the duration of the study, you can check to make sure delegates have the necessary qualifications. You’ll want to compare the log with training records, CVs, and medical licenses from the regulatory binder.

  • Has the staffer charged with recording vital signs during a subject visit been formally trained to take blood pressure? Is it documented?
  • Did an incoming pharmacist receive protocol training prior to the start date of his study assignments?
  • Does state law allow a registered nurse to dispense investigational product, or is a nurse practitioner or physician’s assistant required? Does the protocol require only an M.D. conduct certain procedures? Does the DoA log show the requirement is being followed?

Study Procedures

Even after the focus of the monitoring visit moves past the DoA log itself, you should revisit the log during source document review. Have any study tasks been conducted by staff members who have not received official delegation to do so? Perhaps the protocol requires a blinded IP dispenser. If so, has the delegated dispenser conducted any other study procedure?

PI Oversight

The PI is responsible for ensuring subject safety, compliance with the regs and the protocol, and control of the investigational product. That obligation cannot be delegated away. PI oversight is critical to a successful study, and the DoA log is where PI oversight starts.

Procedures that are performed by unqualified or ineligible personnel put both study participants and study data at risk. These are the very things regulatory inspectors work to guard against. Good monitors know it and make verifying the DoA log a priority.

About the Author:

Laurie Meehan is the Social Media Director for Polaris Compliance Consultants, Inc. She writes the company blog, eNewsletter, and website content, and manages stands behind company accounts on social media platforms. Prior to joining Polaris in 2008, Ms. Meehan worked at a major telecommunication R&D company and taught math and computer science at a local university.

A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

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