Mentorship and career paths are underutilized tools to help struggling entry-level clinical trial professionals find their footing more quickly as trials are initiated, says Susan Alderman, PhD, MSN, RN, clinical research director with the Institute of Stroke and Cerebrovascular Disease at the University of Texas’ McGovern Medical School.
“Initiation is more than a single visit,” adds Alderman, who is also an assistant professor with the UTHealth School of Nursing. Sometimes, early-career clinical research coordinators (CRCs) have not yet been given adequate training and/or mentoring for the process when they are tossed into their first site initiation experience.
The result? “No one likes asking a question because they’re afraid it will make them look stupid,” Alderman says. Unfortunately, those reticent entry-level team members are often hired without prior experience to lean on. In other words, it’s up to the folks representing the study’s sponsor to ensure they get up to speed.
The consequences of getting this wrong range from problematic to severe, Alderman says. “It can derail a study, an institutional review board [IRB] can shut down the study altogether, and the U.S. Food and Drug Administration [FDA] can conduct a ‘for cause’ inspection,” she notes.
Practical Aspects of Study Initiation
Join Susan Alderman at ACRP 2019 this April as she breaks down the site-level study initiation process into three main components to help you improve the start up process. Walk away with practical tips, tools, and resources.
Such actions are all too common, and it doesn’t have to be a huge issue, relatively speaking, to set a trial back, Alderman says. For example, it’s not uncommon for an inadequately trained CRC to not understand how to notify the IRB about an adverse event. An early-in-the-process mistake like that can come back to haunt the study down the line.
Alderman breaks site initiation down into three core components: paperwork retention and flow, logistics planning, and people management. Each requires a clear sense of mission and process. She advises working with a mentor to help visualize study activities, hew tasks to timelines, and keep ideas and meeting notes together in one spiral notebook. “Don’t throw anything away,” she says.
Alderman also advocates creating binders grouped around nine areas:
- Protocol (e.g., Method of Procedure, Investigator’s Brochure, Informed Consent Form)
- Regulatory (e.g., IRB, Adverse Events/Serious Adverse Events, FDA)
- Logs (e.g., staff training, sponsor visits)
- Budget/Billing
- Manuals
- Correspondence
- CVs/Certifications (of site personnel)
- Archives
- Monitor (e.g., correspondence with site staff/investigators, visit logs)
Alderman’s bottom-line advice: “Get a mentor…really, get a couple of them.”
Author: Michael Causey
