Well-written monitoring visit reports will keep you out of trouble, says Kathryn Kimmel, CCRC, CCRA, a senior clinical research associate with PRA Health Sciences.
“It’s the first thing site auditors look at before they visit for a sponsor inspection,” she says. It gives them a framework for what to expect when they walk in the door. A good monitoring visit report inspires confidence, Kimmel adds.
There are several keys to writing a high-quality monitoring visit report:
- Keep the audience in mind. Of course the report will be read by the sponsor and the project team. However, others, including site auditors/regulatory auditors, will give it the once over, too.
- Try to identify and address inconsistencies in how project teams, sponsors, and monitors report and review results.
- Keep it simple. “It’s about quality, not quantity,” Kimmel says. State the facts in a simple way that is understandable to anyone reading the report.
Kimmel also stresses viewing your report thorough a “how, who, what, when” prism. “Tell the story,” she says. “How did it happen, who did it, what are you going to do to fix it, and when will the corrective action be done?”
Vagueness is an enemy to avoid at all costs, Kimmel says. Example: A report that says something like “some informed consent forms were not signed properly.” Specificity is critical. “Which ones weren’t signed? What do you mean when you say some weren’t signed properly?”
Another shortcoming to be avoided: An absence of annotated trip report models. These are “invaluable” as a means to guide monitors. A strong model offers up clear “if/then” decision trees with guidance on how to handle unexpected issues.