In a business niche as highly critical, closely scrutinised and heavily regulated as pharmacovigilance it remains a puzzle why clinical development organisations struggle so often with the “end of process task” of distributing Safety Reports*. These are commonly known as Suspected Unexpected Serious Adverse Reaction or SUSARs. Timely safety report distribution is important because of its part in improving patient safety but also due to the compelling regulatory obligation to distribute this material promptly.
For reference here is how the FDA explain things – p16 of FDA Guidance Safety Reporting Requirements for INDs and BA/BE Studies.
The reality is that this end of process task sounds simple to define but it is in fact pretty complex and time critical. In addition – organisations are often so blindly addicted to using email that alternative, more dynamic and reliable means of information distribution are strangely alien and fantastical. But why not use distribution means that allow for active information distribution, with real-time dynamic readership information? In an age where audience behaviour is closely tracked, isn’t it time you knew who has read your latest Safety Report, and more crucially who has not?
The Addendum in section 8.1 of the ICH E6 (R2) sums up this topic with brevity: “The storage system used during the trial and for archiving (irrespective of the type of media used) should provide for document identification, version history, search, and retrieval.”
Everyone assumes the tagging, labeling and filing tasks will be done later in the TMF (Trial Master File). Here’s the problem: the TMF is so revered and with such concern and esteem as to be paralyzing. Excruciatingly detailed plans for managing documents in the specified eTMF platform are developed, circulated and labored over. The reference model for tagging and labeling and filing is reviewed, tailored and codified to meet the peculiarities of the sponsor or the vendor. There are set-up requirements, specifications and permissions to be sorted. The fast-paced reality of study conduct sweeps everyone along. Documents pile up in the multiplicity of usual places and they are not managed properly for real-time search and retrieval.
Here’s an idea: Keep things simple and don’t procrastinate. Employ a secure platform to get the study documents to sites (please, not email) with tags contemporaneously in place. It is a myth that anyone need wait for an eTMF system implementation. Use the DIA reference model as-is and assign someone responsible for QC along the way. Sure, the elaborate plan for that expensive, highly structured, meta-data-applied and indexed eTMF can still be achieved. It will be easier having managed things so well from the outset of the study.
The MHRA Gray Guide has much more to say about the TMF, devoting 30 pages to the topic in chapter 10. It is a great reference and recommended reading.
This is the second installment of our series on 5 Common Mistakes That Can Derail a Clinical Trial Inspection series. Check back again when we tackle Mistake #3: Lack of Appropriate Document Controls.
By Eileen Daniel, SVP, Development Operations at Caelum Biosciences
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