Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D When should the notification be made

Document information
Reference	GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020
Validity area	GBR
Scope(s)	HM
Document name	GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL
Version / Revision	08-Jul-2020
Status	Current
Document type	Official guideline
Language(s)	EN
Description	GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 4 — Unit 4.1.4
Scope	HM
Document part	D When should the notification be made
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Serious breach, Reporting timeline, CRO, Sponsor

Content

[…] 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, for example, 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, for example, 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 non-compliance. If in doubt about whether and when to notify, contact the MHRA GCP Inspectorate.