Scoring the Compliance of Your Study

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.

A Pharmacovigilance Process Summary

  1. Site reports Serious Adverse Reaction (SAR) within 48 hours.
  2. Sponsor determines if SAR is unexpected or not.
  3. Sponsor reports SUSAR to relevant regulators within days (for EMA within 7 days and typically 15 days for the FDA).
  4. In parallel to step 3 the sponsor has a responsibility to promptly inform other sites once the matter is identified as a safety issue. While there is some scope for interpretation here, “promptly” is normally interpreted as meaning a number of days and not some longer period of time. Typically sponsors will aim to distribute safety reports within 15 days.

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?

Clinical Operations staff typically have a number of pretty effective tools for understanding parts of the compliance picture for their study. These are implicit in the process and system choices that we make when executing a study – and we almost take them for granted. For example

  • It’s easy to track patient enrollment in real time when we use an IxRS system.
  • In turn EDC gives an up to the minute view of CRF completion and query resolution.
  • And any self-respecting central lab service will give you a pretty web portal with sample tracking and reporting progress information.

However there are other process and system “choices” that in effect we make which have profound implications for our understanding of the compliance profile of a study. I put the word choices in quotes for emphasis because that choice is so ingrained and embedded in our daily practice that we rarely consider it a choice at all. So what is that villainous choice we make all the time without fully acknowledging the compliance risk we are giving ourselves? It is using email to share study information.

One of the regulatory obligations that sponsors are commonly wrestling with is that of adequate oversight of studies. Oversight includes ensuring that all parties have the correct, up to date study information at any time that they perform study duties – e.g. run a patient visit or handle a lab sample. The need for sponsor Oversight of study activities (including at sites and by vendors) is not new, but recent regulatory enforcement and the updated ICH E6 R2 affirm that Oversight is a hot topic in our sector.

Put bluntly, expect to be scrutinised closely on issues of Oversight at future inspections or due diligence audits. myClin have a number of customers who have experienced both good and bad inspections with the FDA that pivoted either way on the existence of adequate oversight evidence. Integral to delivering adequate Oversight is understanding compliance. As explained above we normally have some of the tools to understand compliance in some parts of our studies – how and when you use those tools is not the point of this posting.

But a major compliance blindspot comes through our use of email.

It’s practically impossible to use email in a meaningful and efficient way to share information, track delivery and confirm that it’s been read. Sure you might be able to get your email audience to respond to a few “Urgent – please confirm receipt” pleas here and there but that doesn’t scale to the thousands of items of communication every trial experiences. And even when the audience does reply how do your compile and track those replies?

In another spreadsheet?


Resolving this compliance blindspot is central to the mission of myClin. The myClin Compliance Score helps you understand the compliance profile of your study in ways that are currently impossible. Unblinding in a positive way!

All information shared in myClin has an integral audit trail. When a user views, prints, downloads or “files” any item this is recorded. While each of these actions appears small in isolation, the result when scaled across many users and many items of content is a rich picture of compliance on your study. Who are the engaged sites? Who are the laggards? Why does study procedure X keep coming through on monitoring reports as a problem?

This audit trail also serves another purpose. It automatically notes the activity of supervising staff – the Oversight activity. As you read monitoring reports or meeting minutes so you are registering an item view. You are sprinkling a trail of positive Oversight evidence across your study that you can use in future inspections.

It’s time to raise our expectations about information distribution on clinical trials. We know that soon enough inspectors and auditors will be shining a light on these activities with the non-clinical data that support the integrity of your primary clinical endpoints. They will be looking for continuous and contemporaneous evidence of Oversight. We no longer have to be restricted by the awfulness of email. It’s time to eliminate compliance blind spots from your study.

Join us Wednesday, March 11th for our next webinar, Uncover Study Compliance Blind Spots with the myClin Compliance Score, to learn more. Registration is now open here!

By Adam Wood, VP, Business Development at myClin

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