July 10, 2018 | Norman Goldfarb is Editor of the Journal of Clinical Research Best Practices and Chairman of MAGI. His passion is advancing the practice of clinical research by standardizing best practices in incremental steps, so every day is better than the last. He joins Clinical Informatics News with a monthly column highlighting new ideas for advancing clinical research. This month he speaks with S. Eric Ceh of SEC Clinical Consulting.

Eric, what do you think it’s about time for the clinical research enterprise to start doing?

Norm, it's about time clinical research sites properly track and document adverse events (AEs). You would not believe how much time I waste monitoring sites and resolving queries with study coordinators.

Given the importance of AEs, sites don’t track and document them properly already?

Some do, but many don’t. Most study coordinators document newly identified AEs on the study visit note or worksheet. However, they do not always document the resolution or status of any previously identified “ongoing” AEs. The study participant might not report an ongoing AE at each visit, assuming the study coordinator already knows about it. As a result, the study coordinator might not follow-up properly or create a clear record for the AE. The site monitor then has to waste time trying to figure out which AEs were reviewed and then query the study coordinator about gaps in the records.

What would be a better approach?

Sites should prepare for a study visit by reviewing the subject’s interim medical records to identify new adverse events (AEs) and identifying ongoing AEs from the previous visit notes or worksheet to discuss with the subject during the visit. The study coordinator should clearly document these assessments in the visit notes or worksheet so the site monitor has a complete picture of every AE.

Makes sense, what are the benefits?

Compliance with the protocol is always a good idea. This approach would also give study coordinators, investigators, site monitors, medical monitors, and IRBs a much clearer picture of each AE’s history and the site’s safety assessment process. It would maximize the chance that AEs gets properly addressed and minimize the chance that AEs get forgotten and then just marked “resolved” at the end of the study. We would get a better result and eliminate a lot of queries and wasted time for both the study coordinator and the site monitor.

Some sites must have figured this out already, right?

Yes, some have, but not many. Many study sponsors and CROs provide sites with study visit worksheets but few, if any, of them call for updates on ongoing AEs either. And it would be great if all the eSource products were to build these fields into every visit worksheet.

Eric, this approach seems like a no-brainer.

Yes, but maybe I should have thought about all the hours I won’t be able to bill my clients before mentioning it to you.

Too late now…

Norman M.  Goldfarb is Managing Director of First Clinical Research LLC, a provider of clinical research best practices information services.  Contact him at 1. 650. 465. 0119 or ngoldfarb@firstclinical.com.