Regardless of the industry, or how simple or complex the profession, a consistent assessment of job performance is required to determine a professional’s ongoing proficiency.
Experience or status within an organization means nothing, even if the participants are given appropriate training, if they are not evaluated against a validated set of parameters to determine their competence.
In the autonomous field of regional monitoring, in which CRAs are entrusted to manage sites with little supervision, there is a critical need for evaluation visits to confirm proficiency with the protocol, appropriate site management and professionalism and understanding of the study design and therapeutic indication.
An experienced CRA evaluator will accompany CRAs to monitoring visits, annually and as needed, and will perform a review of regulatory binders, source/CRFs and IP storage and accountability. Proficiency, or deficiency, is established as a result. Identified deficiencies are corrected with retraining. It is imperative the CRA understands this is not a corrective action but, rather, a show of employee support, to ensure he/she has the best tools/training with which to perform the job. Deficient monitoring practice is not always the result of inadequacy; it also can be the result of inaccurate training.
There are other CRA evaluation methods. Monitoring feedback forms periodically are sent to sites by the trial or CRA management to gather feedback on CRA performance. CRAs are rated against a list of critical monitoring criteria, with space for comments. Per-site data query rates are analyzed for accuracy of source/CRF review (by the CRA) during monitoring visits. Unfortunately, these assessment tools are imperfect. Feedback forms are meant for objective feedback of CRA performance by site staff, but can be made subjective if content is influenced, positively or negatively, by personal feelings toward the CRA. Likewise, query rates are not 100% accurate, as they sometimes are generated automatically by the EDC system or incorrectly by data management staff. The most effective, unbiased assessment of monitoring performance is the CRA evaluation visit. It provides real-time guidelines for error identification and resolution.
Every CRA is subject to an evaluation visit at some point in his/her career. During a recent evaluation visit, I was reminded that, no matter how much we may think we know, we always can learn from someone else. And after 15 years as a CRA/CRA trainer, I still can get nervous about someone evaluating my performance.
I work on a team of highly experienced CRA specialists, all trained as evaluators. Our site assessment responsibilities precluded the need for our own assessments, until recently. A change in upper management structure prompted reevaluation of departmental policy. For organizational consistency, it was determined each monitoring group would be required to have annual monitoring evaluation visits, by year end. This new directive took effect at the end of the third quarter, causing a mad scramble to organize last-minute evaluation visits. I had not had an evaluation visit in several years, and while I was confident in my performance, I felt a slight trepidation about the impending scrutiny of my work.
I was determined to ace the evaluation, despite less than stellar circumstance. The best monitoring visit I had scheduled, to accommodate the CRA evaluator’s schedule, was a pre-study visit at a relatively new site in a different time zone, for a complicated study that required confirmation of several ancillary facilities. Despite this, I respected the process and was determined to do the best job possible. I sent the evaluator the protocol, pre-study visit slide deck, checklist and summary of my personal visit objectives. I requested the evaluator meet with me 30 minutes before the visit so I could provide feedback on the study endpoints. Though familiar with the protocol, I spent an extra hour reviewing my notes, the synopsis and the visit presentation.
The evaluator was polite and inscrutable. During the visit he remained silent and expressionless, taking copious notes. I knew I had conveyed all critical study endpoints, eligibility criteria and investigator responsibilities, and had confirmed all facilities and staff for the study. But the evaluator’s demeanor left me worried.
When the visit ended, the evaluator said I had done a very good job engaging the site, communicating the endpoints and meeting all pre-study visit requirements. He commended my organizational skills. His only recommendation was that I speak a little more slowly to allow less experienced sites to follow along.
I left feeling relief, as my performance had been confirmed as proficient; gratitude for the professionalism of the evaluator and his silence during the visit; and mirth, for my mother has nagged me my entire life to speak more slowly.
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 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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