By Ginger Steinhilber RN, MS, CCRC, CCRP, OnCore Coordinator & Director of Training, Clinical Monitor, Wayne State University
Q: What is your site’s experience with techniques that help preserve site-sponsor/CRO relationships?
A: We emphasize developing and maintaining a collegial and cooperative relationship with study monitors/CROs. Our coordinators are trained to identify the CRO as part of the team. However, the coordinators are also trained in GCP and are able to identify which requests by study monitors are reasonable and unreasonable. If there are questions, the unit admin and/or nurse manager works with the CRO to find a solution, being aware that the coordinator must continue to work with the study monitor in the future. Thus, we avoid a relationship becoming adversarial and frustrating. The coordinators feel they have backup when they are running a study.
Q: What expectations do you set up-front with the CRO and CRA to have an escalation process in place, so the monitor doesn’t perceive the CRC as being either uncooperative or going behind their back?
A: The process is informal, but quite clear. In our unit, I (or the person who is the nurse manager at the time) will be involved in the study start-up and site initiation process. Thus, I have often met the study monitor prior to the first monitoring visit. In any case, I meet with the study monitor on the first monitoring visit, mostly to stop in and introduce myself. I also let the monitor know that the study coordinator is the key point of contact, that we are committed to quality research, and that he/she should advise me, in addition to the study coordinator, of any major issues that arise during the study.
I approach it with the intention of providing additional support to a coordinator who needs it (e.g., if data entry is late) or providing additional training. I try to stop in and see the monitors while they are on-site for each visit to ask, “How is everything going with the study?” and similar questions. I also let the monitor know that the coordinators will provide me with a copy of monitoring reports, so that we can address any problems internally. That way, the monitor knows that I’m involved in the process. (I am approved by the IRB as a key person for the study.)
Our coordinators are told to come to the nurse manager or unit administrator if the monitor asks for something to be done that does not seem right or reasonable. Our CRCs are encouraged to buy time and tell the monitor that they will have to check with the nurse manager about it. The coordinators appreciate the backup. It’s important for the nurse manager and unit administrator to support and teach, and not to chastise if and when errors are made.
Having been in research for over 16 years, I realize that new monitors are not always aware of alternative ways of doing things. That being said, sometimes the coordinators just have to bite the bullet and do what the monitor asks, even if it seems redundant or repetitious, as long as it meets GCP compliance. In my years of research, I have only had to request (demand) a monitor change once. This happened within the first few years after HIPAA was implemented. We had more than one sponsor and study monitor insist that our site send a screening log (eligible subjects but not yet consented) that included PHI elements. This was a discussion that the coordinator could not resolve alone and was addressed at the admin-level with discussion on HIPAA, GCP, IRB, and unit SOPs. More common are issues such as re-entering data in a different manner than the previous monitor on the study instructed.
Q: Are there any tips for requesting EDC guidelines, query guidelines, or any other documents up-front that could help to avoid the “he said, she said” trap based on different interpretations of GCPs?
A: We do request eCRFs prior to study start so we can develop source documents. Otherwise, we haven’t requested anything up-front.
This post is part of the site empowerment campaign. To learn more about site empowerment techniques, you can find all of the articles here.