Deviation Form

Deviations (defined as ‘any change, divergence or departure from the study design or procedures defined’) include major or critical findings and serious breaches of GCP or the trial protocol, and can be either planned or detected e.g. during on-site monitoring. This template can be used to generate a trial specific Deviation Form and its use is optional. When using this template, please amend the template to make it trial specific.

Date deviation noted: / DD / MON / YYYY
Date that deviation occurred: / DD / MON / YYYY
£ Relating to a UoB QMS document: / Name, code and version number of document:
£ Relating to a trial: / Trial documents affected:
Trial identifier (if applicable):
Site (if applicable):
Participant identifier (if applicable): / RNO/TNO: / Initials: / DoB:
£ Relating to a study: / Identifying details of the study:
Planned deviation: / £ / Detected deviation: / £
Further details of the deviation, (planned) corrective and preventative action:
Details of deviation, and full details and responsibilities of the CAPA required:
For research projects that require NRES REC approval, does the deviation fulfil one or more of the following criteria:
o  Likely to affect patient safety, patient confidentiality and/or data integrity?
o  Relating to significant GCP non-compliance?
o  Shows failure to comply with regulations?
o  Is a recurring deviation and deviations are minor departures of GCP suggesting a systematic quality assurance failure? / £ Yes / £ No / If yes, consider if the deviation meets the criteria of a Serious Breach and process accordingly, see UoB-CLN-CTM-SOP-001 Clinical Trial Management and UoB-CLN-SBR-SOP-001 Serious Breach reporting.
Name of person reporting deviation:
Trial role of person reporting deviation:
Signature of person reporting deviation:
I have reviewed the deviation and agree with the proposed CAPA plan:
Name
Function
Date / DD / MON / YYYY
Signature / Note: The review of the deviation and proposed CAPA plan should be a senior person within the team e.g. Chief Investigator, Principal Investigator, Team Leader etc

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