Site monitoring visit reports are something of an Achilles heel in the documentation of clinical trials, says Roslyn Hennessey, PA, MS, a project manager at Westat.
“When we’re talking about documentation in clinical trials, we are usually talking about source documents,” Hennessey says. Obviously, those, too, are critically important, “but we don’t really talk specifically about the site visit report.”
As someone who has reviewed hundreds in her career, Hennessey says she’s learned “how important they are in terms of conveying information to a lot of different people on the trial team.”
Hennessey draws on experience in the field.
“Several years ago [we] found we were spending a lot of time on site visit report writing and reviewing, because we were finding a whole lot of issues and a whole lot of time was being spend in making corrections for the report to get them to what we felt was a quality report that we would want the client to see,” she says.
ALCOA-C Redefined: Writing Effective Site Monitoring Visit Reports
Join Roslyn Hennessey of Westat at ACRP 2019 this April as she shines the spotlight on the site monitoring visit report and provides guidance on how to not only document observations at the site, but also to effectively communicate key information to the clinical trial team.
Unfortunately, site visit reports are often treated like a “check the box” activity without enough thought given to nuance and the specific information requirements of those who’ll be reading them in the future, Hennessey adds. “A lot of times things are missed or miscommunicated,” she notes. “You can’t capture everything in a check box.”
However, the answer isn’t to go to the other end of the spectrum to produce an avalanche of data. A good site report author isn’t a stenographer, Hennessey says. “You’re not just spitting back out everything that you take in… if you make it like a dissertation people are not going to want to read that report,” she stresses.
Author: Michael Causey