An experienced CRA may follow all the rules and requirements for writing a site monitoring visit report (SMVR), but there are nuances that can make the difference between a report that simply follows that formula and one that really paints a picture its audience can understand.
Roslyn Hennessey, senior project manager at Westat describes the ideal SMVR as “a snapshot in time of what’s happening at the site.” To develop that snapshot, start by asking who will read the report, she advises. There are several types of audiences for SMVRs, all of which have slightly different interests:
- The sponsor wants to know about the performance of the site — is it in compliance with the protocol, are improvements needed, are there any major concerns;
- The PI and site staff want to know if additional training or procedural changes are needed;
- Regulatory authorities and auditors want to know if the site is in compliance and, if not, what corrective action was taken;
- Future monitors need enough information to ensure a smooth hand-off from one CRA to another.
It’s important to give all of the key stakeholders the “heart or the core of the information that they are most interested in,” she says.
And although an SMVR should be comprehensive, it also needs to be concise to avoid burying important information or tiring the reader. Writing an SMVR is an exercise in deciding what information needs to go in and what needs to stay out.
“We really need to get more efficient in terms of going just from point A to B,” she says, “but in that A to B, we need to include some important things.”
Hennessey recommends starting at the end. A monitor usually will have an overall message to convey in the report and should choose the information that supports that message. “Know what you want to say ahead of time and write to your conclusion,” she says. “What do I need to say to get me to that conclusion?”
Be analytical in what you write, she advises. A good SMVR is more than an “information dump.” When writing the report, provide the reader with some context instead of just transcribing notes. Explain what those notes indicate, Hennessey urges. Look for common denominators in the findings and identify root causes of problems. Pay attention to trends, from a single visit and across several visits.
In addition to being analytical, an SMVR should be objective. Elizabeth Weeks-Rowe, a clinical research training consultant, advises SMVR authors to keep the human factor in mind. A monitor may encounter many different personalities in a trial, but they should not be reflected in the site report.
“Taking the emotion out of verbiage is critical,” says Weeks-Rowe. “Be factual, not emotional.” If, for example, a principal investigator is less than professional, this impression should not be included in the report. Instead, address any outcome of that behavior. Making sure that all findings are actionable helps avoid an emotional narrative, she says.
Hennessey notes that an attentive monitor can enhance communication between the site and the sponsor. “Sometimes the investigators feel like the sponsor is too far removed,” she says, and wonder “where is my voice heard?” The investigator may feel more comfortable communicating with the CRA, who then passes the information on to the sponsor via the SMVR.
The last step in writing an effective SMVR is recommending corrective actions, Hennessey says. All issues/findings noted in the report should have an associated action and/or resolution. Have a “no finding left behind” policy, she advises. But, she cautions, don’t be overly prescriptive. It’s important that the PI and site staff take responsibility for problems and solutions.
Both Hennessey and Weeks-Rowe stress taking care of the basics, carefully reviewing the SMVR for misspellings and grammatical errors. Flaws in the presentation, Hennessey says, distract from the content and message and ultimately hurt the credibility of the monitor and the company.
Ultimately, the SMVR must be able to stand the test of time, Hennessey says. Trials can last for years and go through several CRAs along the way. “It’s not often that a CRA gets to work with a site from initiation to closeout,” she notes. And a regulatory request for further information or an audit can come at any time. In one case, she says, the FDA came back to question the SMVR 10 years after the fact.
-By John Mitchell
