Monitoring Evaluation Visits-Professionalism, Positivity and Transparency make the process

CLINICAL RESEARCH & PHARMACOLOGY

Clinical research studies are regulated by governmental bodies, at the country level, to ensure patient safety, credible data, and Good Clinical Practice (GCP) standards are maintained. The investigational staff at institutions who execute each protocol are governed by institutional policy/training practices to likewise preserve trial integrity/patient safety. The Clinical Research Associates (CRA)s reviewing trial data at medical institutions must also have proficiency assessed to ensure quality monitoring standards that align with the rule of the respective organization and industry best practices. This is accomplished via the monitoring evaluation visit.

Monitoring evaluation visits are completed at predefined intervals specific to CRA experience, company standards and study needs. The monitoring evaluation visit is the principal measure of CRA performance due to the autonomy of monitoring activity on site. The majority of CRAs assigned to investigational sites in a region work independently at said site, in conjunction with their “in house” colleagues, in performance of site management activities such as data analysis, regulatory review and investigational product (IP) accountability. Due to the independent practice (of the CRA profession), a trained assessor observing their monitoring conduct alongside them in “real time” is the most authentic measure of performance.

The process of monitoring evaluation is broken down into two primary components; the CRA sign off visit and the periodic evaluation visit of more experienced monitors. The sign off visit is completed on CRAs either new to the role or new to an organization, as the initial confirmation of monitoring proficiency. The periodic evaluation satisfies institutional requirements for verification of continued proficiency.

The individuals conducting CRA evaluation visits (assessors) are either CRA managers, project managers or extremely experienced CRAs at the highest tier of employment within their organization. The CRA evaluation process is daunting for even the most seasoned clinical researcher, and fraught with stress (for the CRA) if the individual conducting the evaluation displays a detach-ed, inscrutable demeanor. Unfortunately, the process sometimes elicits critical review as opposed to constructive feedback. Some assessors feel the evaluation must result with some type of “finding” or else their scrutiny is in complete as opposed to the important realization that an evaluation that results in zero findings/proficiency confirmed is to be lauded and the CRA praised for their efforts.

An error driven mindset displayed by an assessor undermines what should be a positive collaboration, where identified learning deficits are corrected, retraining includes supportive measures to address specific areas of improvement as well as re-evaluation of training materials/deployment to ensure optimal understanding, and an outcome that proves to the CRA that their success and comfort is the primary driver. When this is followed the CRA leaves the experience feeling supported, not dejected. Even if the CRA is not successfully signed off or proficiency reconfirmed, this will happen at another visit, with the above noted measures implemented for a successful outcome.

A three-tiered approach to CRA assessment provides solid framework for a positive evaluation process: transparency, professionalism, and positivity.

Transparency

The assessor must prepare appropriately for the evaluation visit with review of the protocol and study documents, that they understand study elements required for measure of CRA performance. CRA activity is unique, is influenced by study design, and investigational site model. Applying a blanket evaluation approach does a disservice to all participants and does not lend the perspective required for holistic analysis.

The assessor must communicate the parameters of the evaluation visit to include time, elements of review and overall visit expectations. The assessor should meet with the CRA ahead of the visit to discuss visit plan and preparation. This ensures unified understanding of participants.

Positivity

The assessor should open the dialogue of the evaluation process with positive demeanor, communication, and intent. The CRA evaluation process is multidimensional and encompasses all aspects of site management: communication, collaboration, protocol knowledge and monitoring principles (regulatory, data review and drug accountability) computers and technology application, and soft skills of empathy, responsiveness, engagement, and professionalism. It is not a black and white, “yes or no” verification process to a rote checklist that a robot could satisfy. A minimum requirement may be met in one category (computers/technology) while proficiency surpasses minimum expectation in another category (monitoring principles). A CRA not meeting full expectation in one category does not automatically fail the evaluation visit.

This initial deficiency may require further investigation with resolution as simple as spot correction (understand the deficit, provide further guidance, look for corrective action and continue). If the deficiency, however, demonstrates failure to understand/apply research principles integral to patient safety/credible data, then the evaluation visit cannot be completed. This does not conclude the evaluation process nor terminate the training element. The assessor should set up a continuing education plan with the CRAs supervisor (if they are not the CRAs supervisor) to address learning needs and establish a secondary monitoring visit where the corrective action is evaluated to determine the CRAs ultimate proficiency.

Even if the CRA does not successfully complete the evaluation visit, they should never depart the process feeling they have failed, and this hinges on the assessor’s narrative. Positive communication and affirmation will build an equitable perspective (understanding what was correct, and what can be corrected) as opposed to the CRA feeling like they failed. It is much easier to solidify a structure that is weakened as opposed to trying to rebuild a structure demolished by ignorance.

Professionalism

This is obvious and should be implemented from the beginning. At the site level, the assessor and CRA should make a point of thanking the investigational site for allowing the additional visit during the monitoring visit. This should especially include the study coordinator/data manager/support staff that are key to monitoring visit conduct. The assessor should extend appreciation to the CRA being evaluated for their participation in the process, for though the evaluation is required, it still adds an additional responsibility to the CRAs already busy monitoring visit. The assessor should ensure to complete their evaluation tasks without interrupting the flow of monitoring visit activities to the point the CRA is unable to focus or complete their required tasks. “Please” and “thank you,” and such courtesies should be extended to all individuals who impact the process. The assessor should fit into the visit dynamic as opposed to creating an additional intimidating barrier.

The assessor should provide positive reinforcement/ guidance throughout the assessment process and should never leave the CRA hanging/wondering about the outcome. The assessor should strive to have a professional, candid discussion with the CRA about performance at the end of the visit or soon thereafter. It is decidedly unfair for the CRA to learn about retraining or performance reassessment needs from their line manager or supervisor; this should be initially communicated by the assessor whenever possible unless extreme circumstance or duress prohibit this.

Case study

A while I ago I was tasked to sign off an experienced CRA on site evaluation visits. She was newly assigned to a psychiatry study, and though extensively experienced with every monitoring visit type, she had never been assigned to a study during feasibility/start up phase and thus had no experience with direct conduct of site evaluation/ selection visits. We had a preliminary meeting where she demonstrated sufficient preparation for the visit, having gathered requisite information on site model and investigator background. She had reviewed the protocol, study design, informational slide deck and all questions required to solicit appropriate information from the site to confirm capabilities for study conduct.

Though her preparation was extensive, she confessed nervousness over presenting to the investigational site as public speaking was not her forte. I advised her to practice the study presentation in front of a mirror, working on word pronunciations, timing, and presentational flow. I gave her small tips to ease nervousness; pause, breathing and maintaining eye contact. The day of the evaluation visit dawned, and as she was setting up the slide presentation, I could see sweat beading on her brow and worry growing in her eyes. A couple of minutes before the investigational staff were due to arrive for the presentation, she informed me that she felt incredibly nervous and worried over the visit conduct and outcome.

I let her know that simply being nervous about the presentation and execution would not be a prohibitive reason for not being signed off, and that multiple elements influenced the dynamic and decision. This seemed to assuage her fears a bit. The presentation began, and though at times her anxiety caused her to speak rapidly, and look down, her knowledge of the protocol and her visit preparation carried her through to success. During the site question discussion, she started off a bit automatic and formal, but soon relaxed enough to engage in friendly banter that was critical to provision of information.

Throughout the visit I purposefully made eye contact and smiled in reassurance. At one point I gave her the “thumbs up” sign which made her smile and soften her style. The visit concluded successfully, and I let her know she was officially signed off for independent evaluation visit conduct. She thanked me for my support and for conducting a fully dimensional evaluation as opposed to a rigid assessment that would not serve the purpose of her success.

The process of monitoring evaluation is not to fulfil a rote checklist assessment of a CRA filling in every box of an automatic template. The purpose of monitoring assessment is a holistic evaluation of CRA strength and areas for improvement, that they fulfill the objectives of overall visit conduct while feeling supported, trained and part of a critical and successful collaboration.

Distinguished speaker and researcher with 22 years of clinical research experience, Elizabeth WeeksRowe has been a Certified Clinical Research Associate (CCRA) with the Association of Clinical Research Professionals (ACRP) since 2004. She is also a Clinical Research Fastrack staff trainer and works as a clinical operations manager for a large life sciences company. Passionate about training through creative and engaging communications, she has multiple Clinical Research Articles and Book updates.

Elizabeth Weeks-Rowe

Distinguished speaker and researcher with 22 years of clinical research experience, Elizabeth WeeksRowe has been a Certified Clinical Research Associate (CCRA) with the Association of Clinical Research Professionals (ACRP) since 2004. She is also a Clinical Research Fastrack staff trainer and works as a clinical operations manager for a large life sciences company. Passionate about training through creative and engaging communications, she has multiple Clinical Research Articles and Book updates.