Perhaps you have heard from relationship gurus that, upon meeting your blind date for the first time, they will probably have decided within 30 seconds if they want to get to know you better or would prefer to leave you by the roadside and move on to the next candidate. No pressure, right?
Like a first date for those seeking significant others in the realm of clinical research, the site qualification visit (SQV) by a monitor representing a potential study sponsor or contract research organization can make or break a relationship, says Lisa Ince, CCRC, CCRA, FACRP, a Project Manager I in oncology trials with the Clinical Solutions division of Syneos Health.
With attention paid to both site and sponsor perspectives, Ince gave a presentation at ACRP 2024 in Anaheim, Calif., in May on SQVs in which she examined issues ranging from feasibility to follow-up to ensure all parties are confident that the studies being sought for sites and the sites being sought for studies are “keepers.” As a supplement to her appearance at the conference, she offered the following insights in response to further questions from ACRP.
ACRP: What is your best piece of advice (or even your top three tips) for monitors, or clinical research associates (CRAs), who are preparing for their first solo SQV and maybe feeling a bit nervous or overwhelmed about the responsibility?
Ince: Do your research and start building your relationship with the site as soon as you receive your assignment. Collect any available documentation and information about your site prior to the SQV. Set up a brief call prior to the visit to understand any areas where the site may have questions or hesitations, and be prepared to speak to those items during the visit.
ACRP: If you could have your way and see any one (or a few) improvements implemented across the industry in terms of how these visits are handled, what would that look like?
Ince: There would be a shift from a checkbox mentality to one of finding those sites that would truly be beneficial to the study, even if they don’t “check all the boxes.” Conversely, I’d caution that, even if a site checks all the boxes, looking deeper to determine whether the site is truly a good fit for the study is a good idea.
ACRP: Recognizing that the visit is a two-way street, what is your best advice for sites that are about to be visited by a CRA who is on his or her first qualification visit?
Ince: Be prepared and ask questions! Just as the CRA is looking to qualify your site, your site should be looking to qualify the study. Know the client and determine whether their culture is a fit for the culture at your site. Understand what they need from your site and show how your site can successfully run the study.
ACRP: Do you have any other takeaways on this topic for our readers?
Ince: The SQV is arguably the most important step in crafting a successful study, and is the start of what could be a very long relationship. Make sure you know exactly what you are looking for, if you are a sponsor, and exactly what you can and are willing to do, if you are a site.
Note: Ince’s presentation is available in the Course Catalog as part of the ACRP 2024 Study & Site Management session replays (login required).
Edited by Gary Cramer
