Monitoring Evaluation Visits are the means by which sponsors and CROs confirm a Clinical Research Associate’s (CRA) proficiency in conducting monitoring visits.
The individual evaluating the CRA will observe (at an investigational site) their site management and monitoring practices to confirm continued sufficiency for independent monitoring or deficient areas for retraining. The degree of deficits identified during the evaluation will dictate the level of retraining, or in some cases, the need for additional evaluation visits. All of this should be communicated in a professional, effective manner at visit conclusion. The content of the message is important; it serves as the basis for retraining measures. However, the delivery of the message is most critical to the recipient’s understanding and acceptance of corrective action.
When an individual fails to reach the level of excellence their profession demands, it can be devastating. The natural recourse is to refocus efforts until the goal is attained—review the protocol, prepare the visit tools and monitoring checklists and successfully execute an independent monitoring visit. Once a deficiency is identified, it is corrected with re-evaluation and specific retraining to educate and prevent future error. The site, the study and, most importantly, the CRA benefits from the process.
Someone who initially fails to meet a certain standard may indeed exceed and redefine the established standard by this means. Someone who fails the initial monitoring visit evaluation may go on to become an effective CRA trainer and evaluator. Evaluators are chosen not just for their monitoring experience and proficiency, but they are chosen for their leadership skills and ability to mentor, serve and effectively impact by words and actions. It is up to the evaluator to help the CRA who does not successfully complete the monitoring evaluation understand that the purposeful process is to validate and educate—not to criticize or undermine performance.
Communicating the message of additional retraining is never easy and can make for an uncomfortable situation if the recipient is defensive or in disagreement with the findings.
The most difficult CRA evaluation visit I ever conducted was with a CRA who had an elevated perception of her abilities. She had been monitoring for a year, but had not yet conducted an initiation visit and was not adequately prepared for such a critical site training. She did not have all of the required visit tools to demonstrate study assessments to site staff nor to complete lab test or drug calculations. She also did not provide a detailed enough study overview commensurate with the protocol difficulty. I could not clear her an for independent monitoring visit.
This was very disappointing. The CRA was extremely defensive when I informed her of the need for further evaluation. I had detailed documentation supporting my decision, noting specific errors and retraining/correction actions. I commended specific proficiency and was compassionate in the delivery. Yet she left the meeting angry and even challenged my decision to her line manager. In the end, her line manager agreed with my findings and my decision was validated. The CRA received additional evaluation and successfully conducted a site initiation visit. Though the outcome was ultimately positive, the experience felt incomplete and unsatisfactory to me. I wanted the CRA to value the outcome and not suffer from the means to achieve it.
Little did I know that I would shortly be given an opportunity to directly witness the far reaching impact of that conversation.
Several months later, I was asked to help co-monitor a high-enrolling academic site for an important oncology study. This was a high profile site that had a large number of study patients. To my surprise, I was assigned to work alongside the CRA I had deemed in need of further evaluation. To my relief, the co-monitoring evaluation was not mentioned and we worked professionally together. The CRA had clearly progressed, demonstrating exceptional monitoring skills. She even assisted me in identifying a serious ICF language deficiency.
Later that afternoon, I complimented the CRA on her performance. She thanked me and smiled in appreciation. Though she never verbalized her feelings, we both received closure that day. Her effective monitoring abilities were, in part, the result of effective re-evaluation, which served the bigger picture of successful study conduct. I like to think she had learned to respect a process that made her a better monitor.
Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in a variety of clinical research roles. Currently she works in relationship development/study startup in the CRO industry. Email email@example.com
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