Reflecting on 3rd EU Clinical Quality Oversight Forum

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?

Once again Kristen Hunter, ExL Events and David Fryrear, Abbvie delivered an engaging and stimulating programme. Thanks both! Here are some personal observations shared in the spirit of collaboration.

Inspector Access to the TMF

Repeated references were made to inspector access to the TMF. Sponsors had anecdotes relating to this and the 2 regulators present confirmed that this is an entirely normal expectation. Inspector (or audit) usage is often slightly different to normal line of process usage because inspectors need to constantly cross-reference between items – so need to have multiple items of content open simultaneously. Can they do that in your eClinical systems?

Consistent with my experience of regulators being well informed members of our industry who know all the tricks and tools available to sponsors and CROs the MHRA representative, Paula Walker, shared how the MHRA is now often starting inspections remotely from their own office via web meeting and securing access to relevant systems before they go on site at the sponsor. This allows them to get orientated to the study in question in advance and to iron out basic logistics – sounds rather like good practice preparation for a monitoring visit!

All TMFs are hybrid

All TMFs are hybrid was another common message this week. The reality is that whenever “the inspector calls” your study information is almost always spread across a number of systems, including paper ones, only one/some of which are actually eTMF systems.


  • Once the inspector asks for access to you eTMF, they will almost certainly ask for access to other systems: EDC, IRT, labs etc.
  • Despite the promise of eTMF vendors, any given eTMF is very rarely the sole, final source of content for a trial inspections.
  • There is ALWAYS some paper somewhere.

Standalone Inspections of eClinical Vendors

Paula Walker, Senior GCP Inspector at the MHRA noted that they are now doing standalone inspections of eClinical vendors. This is a welcome difference to the attitude I got from the MHRA 15 years ago when I asked for an audit at the ePRO vendor I worked at back then.

The new MHRA logic is that these vendors are critical to the trial ecosystem and are centres of good / bad practice in their own right. Bad things done by such a vendor on one study are quite likely not to be isolated instances – equally good practices can be lead by, or encouraged by these vendors.

Nightmare Email Trails

My last note is about the nightmare of email trails. There was MHRA and audience agreement that “correspondence” sections in TMFs (paper or electronic) are no good to anyone. Correspondence (email, paper, other) should be directly stored in the relevant section of the TMF. However that can start to become tricky when email trails cover multiple topics, including “interesting” matters that you don’t necessarily want to share.

In considering this I was struck with how myClin implicitly avoids the separation of TMF content into pieces of correspondence. Essentially in myClin there is no separate content type of “correspondence”. All content gets organised and coded intrinsically as part of the creation and sharing process. So the nightmare of email trails is automatically avoided.

By Adam Wood, VP, Business Development at myClin

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