Reference:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 D What needs to be reported

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 What needs to be reported
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Serious breach, Definition, Good clinical practice, Protocol

Content

What needs to be reported?

• Any serious breach of: (a) The conditions and principles of good clinical practice in connection with that trial (as defined in UK legislation); or (b) The protocol relating to that trial, as amended from time to time in accordance with regulations 22 to 25.

• For the purposes of this regulation, a “serious breach” is a breach which is likely to effect to a significant degree: (a) The safety or physical or mental integrity of the subjects of the trial (this should be relevant to trial subjects in the UK); or (b) The scientific value of the trial.

The judgement on whether a breach is likely to have a significant impact on the scientific value of the trial depends on a variety of factors, for example, the design of the trial, the type and extent of the data affected by the breach, the overall contribution of the data to key analysis parameters, the impact of excluding the data from the analysis etc.

It is the responsibility of the Sponsor to assess the impact of the breach on the scientific value of the trial.