Things You Need to Know About Delegation of Responsibilities in Clinical Research
Delegation of responsibilities related to a clinical trial is an area that is not always properly understood by the investigators. Incidents with the completion and maintenance of the Delegation Log are repeated over and over across all the research sites which suggest that the investigators did not receive appropriate training.
This article will clearly explain what the principles of delegation are and how a Delegation Log must be completed and updated.
ICH GCP Section 4.1.5 “The Investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties”
This article clarifies what “delegation of trial-related duties” means and what are the regulatory expectations.
Use of Qualified Staff
As discussed in one of our previous articles “Why you should be qualified to conduct clinical trials as per ICH GCP”, the Principal Investigator (PI) first needs to confirm that their team members are qualified and trained to discharge their roles in the study, and that their qualifications are documented.
The PI is required to maintain a list of persons to whom significant study duties have been delegated and it is expected to maintain it throughout the study [ICH GCP E6 (R2) 4.1.5]. Such list is commonly referred to as “Site Delegation Log” or “Site Signature and Delegation Log”, moving forward “Delegation Log” (DL).
A DL provides information such as the staff printed name, initials, date delegation began, date delegation ended, and what tasks were delegated to each study team member.
The Delegation Log is an official regulatory document and is always requested during audits and inspections
Delegation of Duties: Principles of Delegation
Conducting a study is a team effort with several critical activities running at the same time therefore the PI often needs to delegate certain study related tasks to subordinates, colleagues, or other contracted third parties not under the direct supervision of the PI.
Let’s gather additional information in how certain study related tasks are delegated to study personnel by the Principal Investigator by reviewing the principles of delegation:
Some tasks can ONLY be delegated to medical doctors. For example, adverse events and serious adverse events assessments can only be conducted by a medical doctor and not by a study nurse.
The PI has to ensure that each individual conducts ONLY the activities delegated to them in the Delegation Log, and ONLY after they have received training on those activities.
The PI must also ensure that study staff do not conduct any study activity prior to their recorded start date in the DL.
Throughout the study conduct process, the PI remains responsible for the delegated tasks until they are completed, and the study is closed.
The overall responsibility of the study cannot be delegated by the PI
Some example of delegated tasks are:
Obtain/Conduct informed consent
Enter/correct eCRF data
Prepare/dispense investigational medicinal products
Assess adverse events, serious adverse events
Site Delegation Log
The sponsor can provide a DL template, or the site can use their own template if their log meets all the sponsor’s requirements.
A sample of a standard delegation log template can be found at the TransCelerate website: www.transceleratebiopharmainc.com
Conclusion
The delegation of duties is not just a paper exercise and PIs need to take it seriously.
As GCP auditors, we always raise observations related to the delegation of responsibilities at the investigational sites. For example, when reviewing source documents, we sometimes realize that an investigator who was not delegated and who had not received training in the study protocol conducted study specific tasks.
It is also quite often seen during site audits, that the PIs delegate the IMP handling to the site’s Pharmacy staff and that they do not keep an adequate oversight. It is like their responsibilities disappear once the tasks are delegated. However, when serious issues arise related to the IMP, the investigators are totally shocked and angry, and a war starts between the PI and the main Pharmacist.
All investigators should understand and be reminded on a frequent basis that the delegation of tasks is neither a simple paper exercise nor the hot potato game.
We have created an engaging ICH GCP E6 (R2) online course covering the delegation of trial-related tasks topic amongst other critical areas that investigators and other clinical research staff conducting clinical trials need to properly understand…
References
Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6(R2). November 2016.
Author: Dr Leire Zúñiga, Director and Principal GCP Consultant
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