A Clinical Research Associate’s (CRA) job can be very demanding and involve intense multi-tasking. There are many facets to the job outside of on-site monitoring including study start up activities and regulatory document maintenance, keeping up with Sponsor and site communication, remote data review, and team meetings just to name a few. But two of the most important deliverables a CRA has to meet is the timely completion of their monitoring visit reports and follow-up letters. Without this report, there is no documentation that the monitoring visit occurred. The follow-up letter is the site’s documentation of the monitoring visit and their action items to be completed. It is also the report that everyone on the clinical team reads to see how the site is performing and the study is progressing. These reports are the critical deliverables from the monitoring visit.
The most common complaint we receive from Clients is late monitoring visit reports and thus late finalization of the report and follow-up letter. We realize many factors can impact delivering a late report. CRA’s are often overburdened and asked to do more on site monitoring than initially allocated and still meet the monitoring visit report and letter deadlines. Sponsors can delay the review process on their end causing late finalization of the reports and letters. However, it is the CRA’s job to meet this deliverable on time, especially for submission of the initial draft of the report and letter. Time to finalize reports and letters may be outside of the CRA’s control but submission of the draft versions is completely in the CRA’s control. When you step aside and look at the big picture, late trip reports can delay a study’s completion and ultimately may delay getting an effective product into the hands of doctors to treat patients who may need them.
If you, like many other CRA’s, feel overburdened and struggle with finding time to complete trip reports, click here to read a great article on tips to increase efficiency when writing monitoring visit reports and submitting them on time. You may also find this website to be a useful link for other clinical operations issues open for discussion.