Delegation of Authority Worksheet: 8 Considerations for Clinical Trial Activities

April Schultz
July 13th, 2017

In today’s clinical trial landscape, it’s not possible to conduct cutting-edge research without a quality study team. Capable and trustworthy staff members spread the trial workload and allow principal investigators (PIs) to take on more complex studies. However, as valuable as this team is, the PI is still ultimately responsible for study conduct and must maintain compliant and ethical delegation of authority.

Delegation of authority in clinical research

By definition, delegation of authority is entrusting someone else to do parts of your job. In clinical research, this means PIs can allot trial-related tasks to their staff members to perform on their behalves, but they never relinquish responsibility for those tasks and their outcomes.

The FDA requires PIs to personally conduct or supervise clinical investigations, ensuring the study is conducted accordingly and maintains data integrity. This includes determining when and to whom it is appropriate to delegate particular trial activities.

Looking for a better way to manage the regulatory compliance process? Read this related article.

A number of factors need to be taken into consideration when deciding if a task should be delegated, including whether or not your regulatory body expects the PI to perform that activity.

Some tasks are more straightforward than others and can often be delegated to the appropriate individuals, including:

  • Regulatory paperwork/monitoring of completion requirements
  • Recruitment
  • Data entry
  • Sponsor communications not relating to subject safety
  • Clinical trial finances
  • Changes to the protocol not affecting study design and/or risk

Then there are tasks that should always be conducted by the principal investigator, such as:

  • Changes to the protocol affecting study design and/or risk
  • Review of severity of adverse events
  • Appropriateness to include potential participants in alignment of protocol inclusion/exclusion criteria
  • Assessment of primary outcomes

Many clinical trial activities, including those listed here, aren’t cut-and-dry and it’s questionable whether or not it is ethically responsible for the PI to assign the activity to someone else. Download your free copy of the “Delegation of Authority Worksheet” to learn eight factors to consider when deciding to delegate or not to delegate such tasks.