Topics: 21 CFR 812.140, Documentation, FDA, Clinical Research
You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
Most of us have been there before. In an attempt to get that last item completed before the end of another long day on the job in the field of clinical research we inadvertently scribe the wrong date on the research record we are completing. We are all human after all, and mistakes do happen from time to time. Sometimes we know instantly and can correct ourselves, and others someone else points out the discrepancy that we may have over looked. It’s how we respond after we are made aware that we have made the mistake that I want to focus on for this blog post because there are multiple different options one can take.
Topics: 21 CFR 812.140, Research Record, Case Report Form, Clinical Research
In clinical research this phrase is used to emphasize the importance of complete and accurate documentation to site staff. Still, every year we see that FDA issues multiple warning letters which cite, “You failed to maintain adequate and accurate records.”
Topics: 21 CFR 812.140, Documentation in Clinical Research, FDA, Warning Letters