Clinical Researcher—June 2023 (Volume 37, Issue 3)

ON THE JOB

Elizabeth Weeks-Rowe, LVN, CCRA

 

The pre-study evaluation visit is far more than a clinical research associate (CRA) confirming an investigational site’s facilities, equipment, and personnel for potential study participation. The pre-study evaluation visit is the impetus for relationship development/sustainability with the investigational site, and if conducted appropriately, builds the framework for the collaborative relationship integral to study conduct. The CRA is an extension of the study sponsor, and his or her behavior bears the weight of this representation. The CRA must therefore cultivate a positive impression at the beginning of the evaluation visit process; the resulting outcome will influence site selection, site willingness to participate, and future endeavors. It must be navigated carefully.

Making the First Impression Count

First impressions are multifaceted, fluid; they lay the groundwork for a growing, more mature impression that builds to the current impression and onward to a lasting impression, whether positive or negative. A successful impression is borne of professionalism, supported by preparation, and should be framed with positivity for the outcome desired.

There are specific behaviors, when demonstrated by the CRA during the pre-study evaluation visit, which will elevate visit conduct and ensure a positive impression with the investigational site. For example, the CRA should:

• Be flexible when scheduling the pre-study evaluation visit with the site. The CRA is scheduling for one, whereas the site representative is scheduling for multiple participants/departments and has less flexibility. Successful accommodation requires compromise.
• E-mail the study coordinator a list of questions to be asked ahead of the visit. This helps the site to better prepare for the visit, and the CRA may even receive answers to some questions before the visit. This facilitates effective time management and support for all participants.
• Provide an agenda that delineates activities, required attendees, and timeframe. This provides the site with the parameters to organize personnel and logistics effectively.
• Provide the principal investigator (PI) and site personnel with the protocol, slides, and all documents to be reviewed/completed in advance of the visit.
• Obtain the correct address and directions to the investigational site from the study coordinator/site representative, instead of relying on an address in a database that may be incorrect.
• Print a copy of the slides and protocol to bring to the visit and provide for any attendees who want to write notes during the presentation. Obviously, the site can print copies, but this is sometimes forgotten in the rush to organize things. It is helpful to a site if the CRA does this. Alternatively, if there is an equipment or internet failure, printed copies ensure the visit can proceed when there is no other option for review of information.
• Bring the schedule of assessments from the protocol to the visit, as it provides a large-scale view of protocol activities and helps the site further consider its capabilities (visit frequency, patient burden, timing, resources).
• Arrive at the site 15 to 20 minutes before the visit. Punctuality demonstrates respect for others’ time and the CRA’s efficiency, and gives the CRA extra time to set up.
• Be very familiar with presentation content and mindful of presentation timing, due to unanticipated or unavoidable schedule changes by site staff. At the pre-study evaluation visit, the CRA should confirm how long the PI is available in person and adapt accordingly. For example, if the PI’s availability changes from 60 minutes to 20 minutes, the CRA can pivot and only review the most critical required information to fulfill visit requirements.
  

Other Courtesies and Considerations

If the PI is unexpectedly not able to attend the pre-study evaluation visit, the CRA should not automatically reschedule the visit. The CRA may be able to schedule a teleconference with the PI to review protocol and required information soon after the pre-study evaluation visit, while still completing the onsite evaluation visit with the remaining site members. This will prevent revenue loss associated with changing travel and schedules. The CRA must obtain permission from study management to follow the aforementioned process.

During the protocol presentation, the CRA should stick to the critical points and let the bullet points guide discussions and supplement attendees with information. It is not necessary to review every bullet point and every slide in the presentation, and the audience will appreciate this effort.

The CRA should be professional, respectful, and kind to site staff. They are graciously allowing an “outsider” into their facility and committing a large amount of time for study consideration.

The CRA should be clear on the questions to ask and the information to present. Lack of preparation will hinder what should be an efficient and equitable process.

The CRA should understand that the pre-study visit is a reciprocal consideration. The site personnel are assessing the CRA as much as the CRA is assessing them. If the CRA is informative, patient, and positive, it will result in transparent and professional dialogue that illuminates and engages all players.

The CRA should give positive feedback. If the study coordinator was responsive and fulfilled all advance requests to organize the visit effectively, make sure to thank the study coordinator and inform the PI of the study coordinator’s effort. If the PI was generous with his/her time, thank them sincerely; the investigator’s time is very limited and this investment shows their high regard for the study/contract research organization/sponsor.

Conclusion

Hardworking site personnel deserve recognition and respect, for they are in the proverbial trenches executing study activities and preserving the tenets of patient safety and credible data that are the framework for the clinical trials we conduct.

Elizabeth Weeks-Rowe, LVN, CCRA, (elizabethwrowe@gmail.com) is an independent research consultant and former clinical research coordinator with a track record of expertise in site selection and education for the contract research organization industry. She last wrote for Clinical Researcher in October 2022 (“Lessons from Female Innovators in Clinical Research”).