Dr. Smith certainly is the most earnest and resourceful investigator I have encountered in my clinical research career.

He had not yet had the opportunity to lead a clinical study as Principal Investigator, despite a strong desire to do so. But, armed with a lot of bravado—and zero experience—he had convinced a colleague, a busy PI, to allow him to serve as Sub Investigator on several trials to learn clinical research. He excelled in this role. This impressed the PI so much he chose Smith to temporarily fill in for him as the co-PI on a study when he took an unexpected personal leave. Smith flourished in this position and, as a result, expected a smooth transition to the role of PI. 

But he underestimated the difficulty of building trust with sponsors without research experience, and the challenge of being selected as a PI under this circumstance. Though he had temporarily assumed PI responsibilities on a study and met the minimum PI requirement as per the 1572, without a sponsor entrusting him with this task he was unable to progress from the Sub I role. 

Steps an experienced Sub Investigator can take to transition to a PI role

1.	Have a more experienced PI observe the new PI’s first several patient screening and randomization visits. Document the training plan and present it to sponsor staff evaluating the site.
2.	Hire experienced site staff to run the study, both for the clinical and administrative functions.
3.	Ensure the site has all necessary equipment, IP storage and lab certificates required for the study. Read the protocol, solicit outside professional opinions on the basic requirements for a site to conduct a study and build upward.

Smith was vigilant in his quest to establish a successful research practice and was willing to do whatever it took, however menial a task, to prove his worth to lead a clinical trial. He subscribed to the philosophy of team work within his clinic, engaging and learning all aspects of his employees’ jobs. He would process lab specimens to expedite patient screening, complete electronic case report form (eCRF) entry and query resolution during interim analysis and complete patient visits when his study coordinator was ill. His drive and desire were contagious. I wanted him to succeed and be selected as a PI for our study. The level of involvement he demonstrated would translate into rigorous oversight of our study management. 

I met Smith when I evaluated his site for an asthma study. He had arranged for an experienced PI, already selected for the study, to serve as his mentor. The PI had agreed to observe Smith conducting initial patient screening and randomization and assist him throughout the trial to ensure his success. Smith had created a clever solution to the problem his inexperience presented—he would work under a trusted PI and earn his proverbial stripes. 

However, a last-minute change almost lost him the opportunity, and would have robbed us of a wonderful investigator. Smith greeted me when I arrived at his site. Though polite, he was visibly distressed as he explained that the previous evening the PI who had agreed to mentor him unexpectedly pulled out of the arrangement without explanation. 

Smith’s next words gave me pause, as he asked that he still be considered for the study. “I have blocked off the entire morning for this visit. I know our site is equipped to conduct the study. I ask that you give us the chance to prove it.” 

I was touched by his sincerity. He had worked so hard to arrange everything. My sympathetic side wanted to rally to his aide; however, the auditor in me knew I had an objective task ahead. I needed to evaluate his site as I would any other. It was up to the sponsor to make the ultimate selection, based on my findings. I said I would proceed. 

We started with the protocol design, which he discussed with confidence, offering insight into study procedures and how to best implement within the clinical practice setting. He quoted eligibility criteria and its impact on overall study enrollment. It seemed he had memorized the protocol. 

We then moved to staff experience. Smith had a seasoned nurse practitioner as his research nurse and an experienced medical assistant to coordinate the administrative aspects of the trial. He also had arranged for the physician next door to serve as his Sub I. This would be the only trial at the site. 

We proceeded to the facilities tour. Smith showed me his clinic—five clean examination rooms with brand new digital blood pressure monitoring equipment, locked study drug storage with a calibrated min/max thermometer for accurate temperature monitoring and a clean, organized lab area with updated CLIA and IATA certificates for lab personnel. Sufficient experience, facilities and staff for study conduct had been objectively confirmed. He had met every evaluation requirement. 

I never had an investigator participate in the entire pre-study qualification visit or met one more determined to be a PI. Due to my recommendation and his outstanding efforts, his site was selected. Upon being notified by the sponsor, Smith called to thank me. I reminded him that his effort had resulted in the study award; the title of Principal Investigator was richly deserved. 

His conscientious attention during the evaluation visit was a strong indicator of his future level of involvement as a PI, which would ensure the safe and ethical treatment of the patients he would manage and the quality of study data his site would produce.

Elizabeth 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 currently works in relationship development/study startup in the CRO industry.

This article was reprinted from CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »