In the conduct of clinical trials, proper delegation of responsibilities to appropriately informed, experienced research staff is not merely encouraged, but required of the Principal Investigator (PI).

It extends beyond best research practice and is referenced in section 9 of the 1572, Investigator Commitments: “I agree to ensure that all associates, colleagues and employees assisting in the conduct of the study are informed about their obligations in meeting the above commitments.”

Appropriate delegation of responsibilities is one way to ensure adequate PI oversight of the trial, for it demonstrates the PI’s consideration of correctly trained staff to fulfill study roles. But what dictates adequate PI involvement in the trial for which he/she is responsible? 

Whether assessing sites for study participation or conducting routine monitoring visits, it is essential to ensure the PI, delegating patient treatment and procedures to Sub Investigators (Sub Is), maintains both appropriate oversight of and involvement in the trial. PI oversight and PI involvement are not mutually exclusive. Nor is there a precise algorhythm to correlate the correct ratio of involvement to oversight. Many factors contribute to this sometimes subjective determination, including the site model, the investigator’s available time and the complexity of the therapeutic indication. 

Site models and investigator practices vary and so require special consideration for processes at study startup and throughout the lifecycle of a trial. Here are two examples of site models in which the PI delegates patient treatment responsibilities to Sub Is while following best practice to ensure both PI oversight and involvement.

A PI at a large academic institution in a complex therapeutic indication most likely will work with a team of Sub Is who share in study patient treatment responsibilities. The level of delegation sometimes depends on PI availability vs. PI involvement. The PI may serve as a key opinion leader (KOL) and may travel extensively to speak about the therapeutic area. Or the PI may serve as a clinical professor with additional teaching responsibilities. If the PI is available only to treat a small percentage of study patients, the bulk of patient treatment will fall to the Sub Is. In this scenario, site practices must ensure sufficient PI oversight and involvement by establishing a consistent communication infrastructure.

In a large, private physician practice, in which the PI works with a large number of physician partners who serve as Sub Is, study patients sometimes are exclusively treated by whichever investigator enrolled them in the trial. With this established treatment paradigm, sites may have documented SOPs or guidelines that dictate and regulate PI oversight and involvement with study patient treatment. 

Recently I encountered a unique level of delegation by a physician contracting with a large, dedicated research site as the PI for its clinical trials. He served on the board of directors while maintaining a thriving medical practice. In speaking with the site director about research patient treatment and evaluation, I was informed the Sub I, a nurse practitioner, was delegated the majority of study patient treatment and procedures. The PI fulfilled oversight by signing off on patient eligibility, Adverse Event causality and central lab results in the source documents. He also co-signed each patient’s chart at trial completion. He was apprised of patient status and maintained oversight, but without direct involvement in patient care. 

It would have been more appropriate for the PI to complete a portion of direct patient care and evaluation, as opposed to 100% delegation of study treatment. Upon recommending this to the site, the PI and director were very amenable to modifying their current practice to ensure the appropriate level of PI involvement to accompany the oversight plan. The PI would complete all physician evaluations at the screening and randomization visits for study patients, with the Sub I completing all subsequent study treatment evaluations for patients at the remaining study visits, thus assuring an adequate balance of PI oversight and PI involvement in the trial.

Regardless of the site model or patient treatment distribution process between a PI and Sub Is, PI oversight is an undisputable requirement. Oversight ensures the PI fulfills his investigator commitments, while direct involvement in patient care contributes to the safe and ethical treatment of study patients for which the PI is responsible.   

E lizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in a variety of clinical research roles including CRA, CRA trainer, CRA manager and business development director. She has written and edited newsletters for several CROs, created training curriculum for CRA/clinical research educational and training programs and is a contributing writer to several research publications. She currently works in relationship development/study startup in the CRO industry.

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