The Delegation of Duties – Where the Buck Stops
Busy clinical investigators who have additional patient care duties can find themselves in a perpetual state of multitasking. It is common for investigators to delegate certain study-related tasks to their study staff, or to colleagues. This can include study coordinators, study nurses, pharmacists, among others.
Sometimes investigators run into problems when the people to whom the tasks are delegated do not perform their duties according to regulatory guidelines or within the written protocol.
The principal investigator remains responsible for protecting the rights, safety, and welfare of subjects who participate and enroll in their studies. Regardless of who may have breached the guidelines, the investigator will be the one receiving the FDA warning letter.
FDA and ICH/GCP Guidelines call for investigators to ”maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.” This documentation can be called Delegation of Duties/Responsibilities Log or Delegation of Authority. Not only should it include the names of the study personnel with required signature or initials, but also the specific duties and tasks they will be conducting during the study and dates of involvement in the study.
Types of duties that can be delegated
An investigator can delegate a variety of activities related to a clinical trial, including:
- Obtaining informed consent from study participants
- Preparing or dispensing investigational drugs or devices
- Conducting clinical exams to evaluate response to the investigational drug
- Collecting vital signs or documenting medical history
- Assessing adverse events
- Assessing eligibility criteria
- Maintaining regulatory documents
While there may be a variety of people that have interactions with patients and study subjects, the regulatory guidelines address only those activities and tasks that are significantly relevant to the conduct of the study.
A principal investigator is responsible for ensuring that team members are qualified to conduct the duties being delegated to them. Qualifications include appropriate education, training, and level of experience. In some cases, state licensing or hospital certification may be required. Sometimes a protocol may specify the qualifications of the individuals who are to perform certain protocol-required tasks.
At a minimum, the investigator should ensure that staff:
- Are familiar with the purpose of the study
- Have an adequate understanding of the specific details of the protocol
- Have completed the necessary protocol training and documents it
- Are aware of all applicable regulatory requirements and accepted standards for the conduct of the study and the protection of human subjects
- Are informed of any pertinent changes during the study and receive additional training as appropriate.
In addition to documenting the qualifications of assigned team members, an investigator should also document the following:
- Any financial interests or relationships with sponsors as required by federal regulations and institutional policies.
- IRB approval of key personnel
Document the Delegation of Duties
The Delegation of Duties/Responsibilities Log and accompanying documentation (CVs, medical licenses, documented trainings and certifications, conflict of interest documents, etc.) should be kept on file with other regulatory documents for each clinical research study. This is often kept in a so-called “regulatory binder.”
At a minimum, the Delegation of Authority Log should contain:
- The individual’s full name, signature, and/or initials
- Duties assigned
- Date duties assigned
- Dates duties completed (if applicable)
- Signature of PI indicating that he/she has reviewed the duties delegated to an individual and authorizes approval
The log must be updated with any staff changes that would result in a change or termination of duties as it pertains to that protocol. BRANY’s Quality Assurance (QA) auditors often observe that research sites miss this important step when onboarding new research staff to an ongoing research study. When sites fail to add staff to the delegation of authority log, it may also mean that the new research staff member may not have been approved by the IRB to carry out study procedures. Sites commonly fail to also confirm all study personnel listed on the delegation of authority log have received IRB approval. These oversights must then be reported as a major deviation to the IRB.
Institutions and research sites should be sure that the form they use is easy to understand and achieves the overall purpose of the document.
The Society for Clinical Research sites offers this free and customizable template.
You can download BRANY’s DOA template here.