16
Mar2015

by Krystal Bradford, CIP, research compliance specialist at Cincinnati Children’s Hospital Medical Center

Since my last blog post, I have tried to pay closer attention to things discussed at the 2014 AER Conference that I have incorporated into my everyday work. Several items that stand out to me might be considered minor, but there is payoff in the end. One example is documentation.
If you have read any post-site visit letters from OHRP or FDA, there is almost always a reference to documentation that should have occurred but didn’t. Accurate research study documentation can sometimes get overlooked by a research team, then possibly missed by the IRB, and the result can be an avoidable problem. I am well aware of how important attention to this detail can be.
One of my current job responsibilities for our IRB pertains to continuing review submissions. Since AER14, one of the elements I have incorporated into my pre-review of a submission is to search ClinicalTrials.gov for the study and any information pertaining to it. I’ve already been surprised to find one discrepancy in a study’s documentation, easily rectified, thanks to this check. I was equally surprised to see how easily a small detail could be missed.
Another aspect of documentation is keeping resources like ClinicalTrials.gov up-to-date. For example, if your institution is involved in a study that is required to be published on ClinicalTrials.gov, it may not be your responsibility to update the site. Since you, like me and others who work for IRBs, care about the overall conduct of your research program, you have a vested interest in making sure the correct information is shared. The accuracy of the information you provide on the site ties to the funding of research protocols, data analysis, and publication of the results. Take the International Committee of Medical Journal Editors (ICMJE), which requires registration of a study in a publicly available and searchable system. Several other journals have adopted this policy. So not only is it a requirement by law, it is a requirement if the researcher intends to publish results. It’s easy to see, then, how this “minor” detail of accurate documentation—inadvertently overlooked by the research team, and then possibly missed by the IRB—could end up in a letter from OHRP or FDA and could have widespread implications for the overall research enterprise.
The seriousness of this issue was a hot topic at the 2014 AER Conference, and the trend appears to be that more diligence must paid to ensuring the correct documentation of information. The old saying of “it takes a village to raise a child” could also apply to the documentation trail of a study. It’s a responsibility we all share, and one that I am making a priority at my institution.
I would like to thank PRIM&R for allowing me the opportunity to share my thoughts with everyone via the Blog Squad. It has been a very pleasant and rewarding experience.

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