Skip to main content


We’d like to understand how you use our websites in order to improve them. Register your interest.

File notes and breach reports: when are they appropriate?

Protocol and/or GCP deviations occur in many clinical trials. There are clear definitions and reporting guidelines on serious breaches in Clinical Trials of Investigational Medicinal Products (CTIMPs)[1]. However there is no such national guidance for non-CTIMPs. For any trial design, there is little, if any, information on when and for what type of incident it is appropriate to write a file note or when a breach report is the appropriate action. Should we consider whether an event that has been recorded by a file note but then repeated becomes a breach? There is also lack of clarity about the jargon we (and others) use - violation, deviation, breach - do they all mean the same or, if not, which is the most appropriate terminology to use for what type of event? This lack of clarity leads to confusion and inconsistency.

We will present incidents that we have been directly involved in and discuss how we have handled these. We will also discuss how we have developed our guidance on recording file notes and breaches. This will include definitions, information recorded, how decisions are made and by whom and when oversight by sponsor is required.


  1. 1.

    Guidance for the Notification of Serious Breaches Version 3 (Final 07-02-13).

Download references

Author information



Corresponding author

Correspondence to Alison McDonald.

Rights and permissions

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Reprints and Permissions

About this article

Cite this article

McDonald, A., Cotton, S. & Norrie, J. File notes and breach reports: when are they appropriate?. Trials 14, P133 (2013).

Download citation


  • Public Health
  • Clinical Trial
  • Trial Design
  • Medicinal Product
  • Clear Definition


By submitting a comment you agree to abide by our Terms and Community Guidelines. If you find something abusive or that does not comply with our terms or guidelines please flag it as inappropriate. Please note that comments may be removed without notice if they are flagged by another user or do not comply with our community guidelines.