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?
Even in organizations with low staff turnover, a common clinical trial staffing pattern is that the staff who represent a company in an inspection are not the staff who started the study — for example at the protocol design and site identification stage. This is understandable because to an extent the skill sets and expertise that are optimal at earlier stages are different to those needed later.
Unfortunately, it is all too common for those trial leading staff in the early and middling periods of the trial — when pressures over protocol completion, site initiation and patient enrolment are at their highest — to struggle to pay enough attention to what constitutes evidence of oversight.
The other side of this coin are the staff who join a study team in the build up to an inspection. It is often incredibly hard for them to fully comprehend “the story of the study”. Information is strewn across multiple locations. The evidence is dispersed and at times contradictory. The record of processes and decisions from the early days of the study is lacking. How do they get to grips with what happened during the study — some parts of which happened years ago.
Imagine you are in this scenario in 2021……
When I presented at a recent conference I posed this question to the audience. Being admirably frank most of the audience noted that it might take them up to an hour to find this evidence — and for some it would take them even more than an hour.
Hardly a positive example of your oversight evidence especially as there alternatives available now [Editor: shameless commercial plug coming….] such as the myClin Clinical Oversight Platform. In that situation:
You were smart – and you chose to work a little differently in 2018-9.
Within seconds you open the compliance record in your Clinical Oversight Platform for that 2nd protocol amendment.
There is your evidence that the nurse was trained!
[End of commercial plug – phew!]
Moving on, it’s important to prepare your inspection team well before an inspection and to establish in-house roles and responsibilities for when the inspector arrives. Internal mock audits are a great way to get a feel for both your team’s strengths and weaknesses and also the strengths and weaknesses of your oversight evidence base.
An additional point relates to the sponsor obligation to ensure sites are trained and competent in the procedures for your study.
ICH E6 R2 says:
Training evidence takes a number of forms:
How do you track the delivery of this training and information. Bear in mind that that ad hoc content is often of the highest, most critical value in terms of good study execution and therefore Oversight.
We hope this review of common mistakes in clinical trial inspections has been useful to you. Good luck with your next inspection!
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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