MHRA produced FAQs for Investigator Sites

[MHRA Super Moderator]

4. If there is a change of principal investigator (PI) at an investigator site, can trial activities continue uninterrupted or do they need to be halted until the necessary approvals have been obtained?

The following position has been agreed between the MHRA GCP Inspectorate, the National Research Ethics Service (NRES) and the NIHR Clinical Research Network.

Where a new PI is to be appointed, the preferred process is to plan ahead so that the necessary approvals can be obtained in advance of the handover, ensuring there is no gap. However, we recognise this may not always be possible, for example where a PI leaves the host organisation unexpectedly or falls ill.

Where a gap occurs, the aim should be to enable the trial to continue uninterrupted. The sponsor is responsible for taking prompt action to identify another health professional to take on the role of PI, in consultation with the host organisation and taking into account the expertise and experience required for the trial concerned. Provided that the sponsor and host organisation are satisfied that the individual is suitable and that any risks have been assessed, there is no reason why the trial should not continue uninterrupted. Once the new PI has been identified and agreed to take on the role, new participants could be recruited.

The sponsor should submit the necessary Notice of Substantial Amendment to the Research Ethics Committee (REC) as soon as the new PI has been appointed, so that formal approvals can be obtained to ‘ratify’ the appointment. For NHS sites, the REC will issue an approval letter promptly. For non-NHS sites, approval will follow confirmation of no objection from the site-specific assessment (SSA) REC for the site. REC approval will be subject to the host organisation confirming continued permission.

It is of course open to the sponsor to halt new recruitment until all approvals are formally in place. However, we think it would be undesirable if recruitment of eligible participants was to be held up by administrative requirements where the sponsor is satisfied that an appropriate investigational team is in place at the site. The sponsor should of course be able to demonstrate and justify the action taken.

[MHRA Super Moderator]

5. Can inspectors access medical records of patients participating/who have participated in clinical trials of IMP in the UK if the consent form does not explicitly include consent for Regulators to access these records?

The answer to this question can be found in the FAQs for Inspection process.