Our top 15 EU Regulation 536/2014 questions – Part 2 - Arkivum

GxP / 07 Dec, 2021

Our top 15 EU Regulation 536/2014 questions – Part 2

Following on from our first instalment of regulation 536/2014 questions, we bring you part two in which we delve into more intricate questions asked by CROs and Sponsors.

You can read Part 1 here.

9- Are new documents going to be implemented in the TMF reference model?

Yes, the TMF reference model steering committee is looking at the new requirements and where new artefacts will need to be added to the reference model.

These announcements will likely be published further into the future, or when the next major upgrade is released.

10- Is it possible to export the submission, withdrawal, etc. from the CTIS? Ideally with an audit trail and metadata?

We’re waiting for confirmed details regarding this issue from the owners of the CTIS.

It may be the case that you will be able to take screenshots of the data that you enter on to the CTIS but whether or not that will be sufficient for purpose remains to be seen.

11- Does this regulation apply to trials that ended due to lack of efficacy, or if the trial was aborted?

Yes. If you have ended the trial for any reason at all, you still need to submit a clinical trial summary report detailing:

  • The status of the trial
  • The reasons why it was ended
  • What the outcomes were

You can’t end a trial without a supporting summary detailing the reasons why.

12- How does regulation 536 work alongside GDPR and the rights of the data subject?

Before we answer this question, we’d like to point out that a lot of the GDPR rules don’t apply to clinical trials.

(If you would like further information regarding this, then there is a special category under GDPR for medical records and clinical trial records which would be the best place as your first port of call.)

If you have a patient who is participating in a clinical trial, their information will have to be retained and made available in the case that they need to be made aware of any safety information. If they need to be told about something relating to the trial they took part in, they must be communicated to in a timely manner.

Their records must be retained appropriately for this instance.

A patient cannot request to be deleted from a trial’s records. Deleting these records would be unsafe and unethical.

Patient data must be kept for as long as the rest of the clinical trial’s records and information are retained. The clauses around the purpose for keeping that data must also be maintained

13- How will audio or video consenting be documented in the TMF?

 You must ensure your audio and video recordings can be reviewed throughout the entire retention period which can be a challenge.

In relation to this regulation, you must also archive the consent given for those recordings alongside the audio and/or video files.

The HSRAA have published a guide on this concern which will provide indication as to how you need to archive and preserve them for the long-term.  Making sure you have a format that’s durable will be critical.

14- What suggestions would to offer to Sponsors who choose to maintain certain Zones? e.g., 03 – Regulatory; 07 – Safety, outside the TMF?

This shouldn’t be a concern because the regulation doesn’t actually tell you how you should structure your TMF.

The TMF reference model has become the standard for the way in which you store your information. This means that most inspectors are familiar with it.

It also makes it easier for inspectors to navigate but you do not need to have all your TMF content in one place. If you’re spreading your TMF content over several platforms or applications, you should say that this is the case by stating this on your TMF index or TMF plan you present to an inspector during an audit so that they know where to find that information.

15- SUSARs (Suspected Unexpected Serious Adverse Reaction) resulting in death or life-threatening side effects had to be reported within 7 calendar days. Is this still the case?

Yes, SUSAR reporting hasn’t changed from the original Clinical Trials Directive. It’s still 7 days for death/life-threatening results and 15 days for other effects.

Whitney Armstrong

Whitney is the Marketing Executive at Arkivum. She joined the business in 2020 and is responsible for supporting marketing campaigns and activities targeting key sectors. Whitney has over 5 years' experience of delivering and supporting marketing strategy for technology brands.

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