Investigator Gets FDA Warning Letter for Not Retaining Trial Documents
(Thursday, January 13, 2022)
A clinical investigator received a Warning Letter for not retaining the clinical trial records after the completion of the trial in a rare such letters issued by the FDA. This is an example of the systematic failure not only of the investigator but also the CRO and the sponsor who all share responsibility to maintain clinical trial documentation. The US regulations require that a clinical investigator participating in a pivotal trial retain trial related source documents at least for “two years following the date a marketing application is approved for the drug for the indication for which the drug is being investigated; or, if no application is filed or if the application is not approved for such indication, until two years after the investigation is discontinued.” From the time a trial is completed, the market approval application is filed, and FDA decision made, a very long time could have elapsed, sometimes years. So, practically per the FDA rules, the investigator could be holding on to trial documents for several years. At the end of a given trial, there are several options available to sponsors and investigators to assure proper storage of trial related documents. Since most clinical sites have limited storage space and trial documents are voluminous, investigators are allowed to move the records to long-term storage or even transfer the documents to the sponsor for safe keep. Documents can also be scanned, and electronic copies saved for security. In case the trial documents were generated electronically, it is far easier to store long-term. In this case, apparently, none of the common-sense measures were taken. The sponsor did send clinical monitors to prepare the site for the FDA inspection a month before FDA showed up. The sponsor’s monitors noticed the missing documents, but nothing was done to rectify the error. This is not a very unlikely outcome for an investigator like in this case, who had already decided to not participate in future clinical trials. The FDA Warning Letter would likely have little impact on the investigator. But the consequences for the sponsor could be serious if the site contributed significant data which may not be usable now that FDA has raised red flags for its integrity. This was an avoidable crisis that happened because of the disfunction of the clinical trial quality system. And it is not that hard to repeat for similarly careless clinical teams.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC