Arrangements for notification

D. Arrangements for notification:

Who should notify?

The Sponsor or a person legally authorised by the Sponsor to perform this function (e.g. legal representative or contract research organisation), if this function has been delegated by the Sponsor to another party. In accordance with Statutory Instrument 2004/1031 as amended by Statutory Instrument 2006/1928, the Sponsor retains legal responsibility even if the function is delegated (Regulation 3.12). The CRO is also legally responsible for compliance with the legislation in relation to functions delegated by the Sponsor to the CRO (Regulation 3.8).

When should the notification be made?

• Within 7 days of the Sponsor becoming aware of the breach. If the notification function has been delegated by the Sponsor to another party e.g. a CRO, the 7-day timeline applies to the other party.

• If the Sponsor retains the notification function, then it is recommended that agreements between the Sponsor and other parties involved in the trial e.g. CROs, contractors, co-development partners, investigators, should state that the other party will promptly notify the Sponsor of a serious breach (as defined in Regulation 29A) that they become aware of, in order for the Sponsor to meet their legal obligation. In this case, the clock starts when the Sponsor becomes aware of the serious breach.

• If the Sponsor obtains clear and unequivocal evidence that a serious breach has occurred (as defined in Regulations 29A), the default position should be for the Sponsor to notify the MHRA first, within 7 days, and investigate and take action simultaneously or after notification. In this case, the Sponsor should not wait to obtain all of the details of the breach prior to notification. In other cases, some degree of investigation and assessment may be required by the Sponsor prior to notification, in order to confirm that a serious breach has actually occurred.

• A pragmatic approach to clock start should be employed. Inspectors will review the process for notification during MHRA GCP inspections and delays in notification may be classified as a non-compliance. If in doubt about whether and when to notify, contact the MHRA GCP Inspectorate.

Who should be notified?

• Notify serious breaches to the MHRA GCP Inspectorate. Notifications should primarily be made using the following email address:

E-mail to: GCP-PV.Inspectors@mhra.gsi.gov.uk

• A template form for notifications of serious breaches to the MHRA is attached in Appendix II.

• The Sponsor may initially contact the MHRA Inspectorate by telephone to discuss the breach and follow up with a written notification within 7 days of the Sponsor becoming aware of the breach. For current contact details for the Inspectorate, please refer to the MHRA web site.

• Notifications can also be sent by post or fax to any of the three MHRA Inspectorate offices. Current office addresses can be found on the MHRA web site.

• Wherever possible, MHRA will provide an acknowledgement of receipt of notifications. If the MHRA template form is not used, the written report should clearly state that it relates to a notification of a serious breach.