TMF Document Error Solutions – A Quick Fix to a Lingering eTMF Issue

Time is of the essence in the clinical world- and it’s important that documents are submitted correctly and timely. It only takes one small component of a TMF not being properly managed to prohibit Inspection Readiness.?

?One issue DRS Clinical Document Analysts (CDA) have come across during the QC and attribution process is documents submitted that do not follow Good Document Practices (GDP) guidelines. However, unless the document submitter is aware there is a problem, the documents with issues can sit for weeks or months with no corrections.?

?To facilitate quicker turnaround times for submitting corrected documents, the DRS eTMF now sends an email notification to the submitter moments after going through the QC and attribution process.?Through this method, the CDA indicates the issue reason and includes additional or supplemental information to assist with document correction.?The email notification to the submitter includes a copy of the rejected document, the study, document level, country/site (if applicable) and an explanation of the document issue.?With the notification going back to the submitter within a couple of days of submission, this will assist in correction occurring in a more timely manner.

?Richard McQuade, President and CEO of DRS Corporation says of the new feature, “The proactive monitoring of issue documents has made the teams very productive and certainly shows that if submitters know there is a mistake, they take action right away.”

?DRS Corporation implemented the eReject process into the DRS eTMF version 3.0 release.?This feature is optional and will only be available if selected by the customer.

?Since this process was implemented, the customers who turned the eReject process on have shown a significant improvement for average days to correction.?Some US only studies have correction rates as low as same day to 2 days.?International studies have a higher correction rate, since sometimes translations are required – with averages of 2-4 weeks.??

In one study that has been active in the DRS eTMF for about 7 years, the average days for correction went from 68 days in 2021 to 35 days in 2023, cutting the corrected document turnaround time in half.?This study’s sponsor says, “’eReject’ seems to be effective (at least for a high percentage of the issues) so (DRS Corporation’s) contribution with this new functionality has been significant for this general improvement.”

?CROs that submit documents directly into the DRS eTMF also find the new feature useful.?One CRO who utilizes eReject states, “The process was very easy.?The website / eTMF worked perfectly well.. it was a five star process!”

?If this is something that resonates with you and your study, please feel free to reach out to the DRS Corporation team for assistance in keeping you Inspection Ready.

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