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?
As a sponsor, it is vital to maintain a level of Oversight towards any trial-related duties or functions. ICH E6 R2 states that, “The sponsor should ensure Oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).” That idea can be summarised as:
You can delegate anything – except Oversight.
In many ways a clinical trial inspection is an opportunity for the inspector to review “the story of the study”. The TMF is considered a starting point for telling that story. However any study story is so much more than a simple 2 dimensional “flat file”. So much more than just a long list of all the documents used, presented in their final state.
A 3rd dimension to the story of the study is how did these documents evolve? Who collaborated on them, who approved them, where did they get shared? So the interaction between the many people and organisations who make up your study is essential to illuminating this 3rd dimension.
Therefore it’s important that Oversight happens contemporaneously, like the tagging of documents and files (see Mistake #2). Any communication or collaboration between parties to the study should be documented and noted as it happens. This can be as simple as noting the actions from your weekly team meetings or documenting the context, causes and resolution of an issue that required intervention.
Once again, leaving this documentation to happen at the end of your study leads to extra time, money, and energy wasted – to say nothing of all the interventions that you’ll forget or the intricate sequence of events that you can no longer remember.
Looping back to my opening point, [“You can delegate anything – except Oversight”], in recent years I have found it worryingly common to hear from sponsor staff that managing site relationships is entirely the responsibility of their chosen CRO. If ever you wish to throw a red rag to the metaphorical bull (the inspector) then saying “that’s the CRO’s job” is an excellent, if career limiting way to start. While much of the day to day interaction will be between the site and the CRO, the inspector is likely to be much happier to see evidence of a virtuous triangular relationship between site, sponsor and CRO.
Note: the word Oversight has been capitalised in this article simply to emphasise the point.
This article is part 4 of a five-part series on Common Mistakes That Can Derail a Clinical Trial Inspection. Read the previous post from Eileen Daniel on Lack of Appropriate Document Controls.
By Adam Wood, VP, Business Development at myClin
About myClin: Are you really ready for an inspection? Start using the myClin platform to take control of intricate and error-prone study documentation. Keep essential information at your fingertips to stay audit-ready at all times. Get started with more free resources and a demo at myClin.com
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