My Take on Delegation of Authority Logs: A Broken Process

by Nate Becker, BS, CCRP

There is a lot of discussion on message boards and even more discussion within the clinical research industry surrounding Delegation of Authority logs.

The first item I would like to discuss is the purpose of the delegation of authority log. The purpose of the DOA log is to record all study staff members’ significant study-related duties – which is exactly what the FDA and ICH/GCP guidelines recommend.

There is no FDA Requirement that sites must have a Delegation of Authority Log. ICH/GCP Guidelines state the same. If you refer to the “FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects” all the FDA recommends is this:

The investigator should maintain a list of the appropriately qualified persons to whom significant trial-related duties have been delegated. This list should also describe the delegated tasks, identify the training that individuals have received that qualifies them to perform delegated tasks.

The ICH/GCP Guidelines section 4.1.5 state the following:

The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.

This isn’t to say that sites should just do the bare minimum of what the FDA is recommending, of course sites should go above and beyond recommendations. My issue is that the process surrounding DOA logs has gone over board and gotten out of hand, we need to rewind and re-focus on the intent and purpose of the DOA logs.

I do understand that when sites work with sponsors, sites are in many ways obligated to follow the directives of the sponsor. However, when the directives become nonsensical there needs to be serious discussions to sustain and refocus on the core purpose of certain practices. To be blunt, the requests/directives regarding DOA logs have simply become comical to the point where we have literally been asked to delegate who takes the patient to the medical room.

I underlined the following phrases from the FDA Guidance and the ICG/GCP guidelines: significant trial-related duties have been delegated and significant trial-related duties. This is what has been lost in regards to the purpose of the DOA logs and is one of many issues with DOA logs. Not only are sites asked to delegate very insignificant duties, there is zero consistency from one project team to the next project team even though the project teams and DOA logs are from the same sponsor.

DOA logs are clearly an industry standard of practice and do serve a very practical purpose for sites in that the DOA log functions as the suggested “list of the appropriately qualified persons to whom significant trial-related duties have been delegated”. With that in mind, there needs to be industry wide improvement, understanding and consistency established surrounding DOA logs.

Some Ideas for improvement:

• Sites create their own Delegation Logs and Sponsors/CRO’s allow sites to use them
  • This will provide more consistency for sites. When documents are more consistent, there tends to be less errors

• Sponsors/CRO’s create a “model” Delegation Log
  • There are groups of sponsors that have adopted the 1 page CV from Transcelerate, more Sponsors/CRO’s could collaborate to agree upon a generic delegation of authority log template to use across the board

• Sponsors/CRO project teams should be more involved with sites regarding the tasks that will be delegated
  • Oftentimes project teams will send the Sponsor/CRO generic DOA log template to the site with no guidance as to what they specifically want delegated. The site will be monitored and the monitor will query why a certain task was not added or delegated. If Sponsors/CRO’s want specific tasks (not already on the DOA log template), then they need to play a bigger role in developing the project specific DOA log.

• “Pump the Brakes”
  • We are forgetting what is important when it comes to delegating duties. As mentioned above, the FDA wants to record all study staff members’ significant study-related duties. Sites are getting inundated with requests to delegate “who will walk the patient to the room”, “who will get the patient a glass of water so they can take a pregnancy test” etc. etc. These are tasks that play zero significance in the study and yes, we have been requested to delegate who will walk the patient to the room.

• Delegation of Authority Logs need to be more “user friendly” or streamlined
  • It is my belief that many of the DOA logs used are developed by people that have never or very rarely completed a DOA log. Many of DOA logs we are required to use are a bit too creative for the purpose of the DOA log and they are not easy to follow or easy to complete for many different reasons.
    • Examples
      • Many logs do not have enough room to Print Names, Sign Names and Delegate 15-20 tasks
      • Some logs require the PI to initial and date every single line where a person is added rather than just simply have the PI sign once on each page.
    • Sponsors/CRO’s should reach out to those who use the DOA logs the most (sites) and get feedback from sites on how to improve the log.

These are a few simple ideas to help improve delegation of authority log conundrum and I think with enough pushback from the site level and even the Sponsor/CRO level (there are plenty of Sponsor/CRO staff that share many of the same frustrations) – we can at least start a discussion of changes that could possibly improve a very time consuming and inconsistent process.