The Scoop on Credentialing Site Coordinators
Readiness for a Reason
Bonnie Hennig-Trestman, PhD, is Co-chair of the Huntington Study Group Credentialing Committee.
More than two decades ago, the Huntington Study Group initiated credentialing of its sites, primary investigators (PIs), and study coordinators (SCs) to ensure consistency of clinical readiness. Over the past few years, however, the HSG has seen an increased number of candidates applying to become credentialed PIs and SC who have limited clinical and/or trial experience.
To address this issue, the HSG Credential Committee has revised their standard operating procedures (SOPs) and application process. The goal of the revisions is to ensure that HSG-credentialed PIs and SCs are trained to work with people who are impacted by HD and are skilled at conducting clinical trials.
Credentialing Centers on Preparedness
Preparedness is primary for success as a clinical coordinator. Personally, I can tell you that going into a study with a “trial by fire” mentality is not the best option. Over a decade ago, when I initially became a site coordinator (SC) on a drug trial, I was armed with only experience as a back-up coordinator for an observational study. Although at the time I felt confident as a SC, looking back I realize my limitations.
My site IRB conducted an audit that proved to be a huge learning experience for me. While my initial perception of the audit result felt like a slap on the wrist, I realized later how beneficial it really was. The audit wasn’t a punishment — it was implemented to assure the research was documented properly. A side benefit was that it taught me how to do my job properly and how to keep participants safe.
In fact, following the audit, I asked for ongoing support in order to improve the quality of my documentation. The knowledge I gained from that support was invaluable. Since that time, I have served as a SC for other successful studies, and I credit these to this auditor who became a mentor to me. She made me a better SC, and more confident in my role.
Modifications to Meet More Complex Demands
While mentors play a vital role in each person’s development, the purpose of the HSG Credential Committee is to ensure that SCs (and PIs) are qualified and ready to take on these respective roles. Current studies are increasingly more complex. To enhance the success of these SCs and PIs, the HSG Credential Committee actively works to support the credentialing process.
In addition to other requirements, the Credential Committee has made revisions to the application, which now requires completion of the latest CME4HD courses and case studies. These are offered on demand (https://huntingtonstudygroup.org/cme4hd-online/). Along with providing CMEs, CNEs, or IPCE, these lecture courses and interactive case studies provide an overview of clinical care for people with HD.
Another modification is that the online credential application itself is now more streamlined and efficient. This change allows you, the SC candidate, to focus on the most relevant aspects of your experience and helps committee members to better understand whether you are prepared to conduct clinical trials in your specific roles.
The Qualified Site Coordinator Candidate
The committee reviews each application and pays close attention to the SC candidate’s clinical and research experience. When you submit an application, be sure to include all relevant clinical practice and specifics of any involvement in trials which you have participated.
If you do not have adequate experience, the HSG Credential Committee will send you a letter recommending additional training and mentorship, along with a checklist of recommendations. These include: reviewing the HSG Educational Training Videos, which cover topics such as budgeting, Unified Huntington’s Disease Rating Scale (UHDRS) insights, audits, and evaluation of suicidal behaviors; attending HD clinics at your institution; participating in the HSG Study Coordinator Council, which meets virtually weekly and provides mentorship; shadowing a PI or coordinator at your site; and other suggestions.
Of course, if you are able to complete some of these prior to submitting your application, we strongly encourage you to do that!
It is our hope that HSG members applying for certification take the time to review the credential application thoroughly and understand that receiving approval is much more than just a “rubber stamp.” Becoming a HSG-credentialed SC means that you have met strict standards to ensure the safety of study participants and to assure sponsors that your site is well-prepared and able to “hit the ground ready” when chosen to participate in a study.
If you would like more information about how to become a credentialed SC (or PI or site), please contact the Huntington Study Group at firstname.lastname@example.org or toll-free in North America at 1-800-487-7671.
About the Huntington Study Group
The Huntington Study Group (HSG) is the largest clinical research organization focused solely on clinical trials designed for people impacted by Huntington Disease. Sponsors such as pharmaceutical companies rely on the HSG to set the standard for conducting these studies. While each site’s principal investigator (PI) is ultimately responsible for the conduct of specific trials, as their sponsors look to HSG to provide a pool of potential sites where the staff are knowledgeable and experienced.