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Deviation collection should follow a risk proportionate approach. For example, during trial design, certain deviations can be noted as not requiring recording or reporting.
Section 1 Introduction
Terminology – Deviation, Non-Compliance or Breach?
The terms ‘Deviation, ‘Non-Compliance’ or Breach can be used by a CTU or Sponsor to describe a situation that has occurred where the approved protocol, document or process has not been followed and the situation needs to be recorded and/or reported within the trial for compliance and oversight purposes. These types of non-compliances are difficult to predict and as such a certain level of non-compliance is expected within trials.
However, these are not to be confused with ‘waivers’ which are prospective deviations from the protocol or other approved document/process. These types of non-compliances are not acceptable and are a contravention of the UK Statutory Instrument SI2004/1031
The terms ‘Deviation, ‘Non-Compliance’, ‘Incident’, or Breach can be used by a CTU or Sponsor to describe a situation that has occurred where the approved protocol, document or process has not been followed and needs to be recorded and/or reported within the trial for compliance and oversight purposes. Whilst it isn’t important which term an organisation chooses to use, the terminology must be used consistently across all of their Quality Management documentation to ensure a consistent approach to recording and reporting.
Here we will use the term Deviation.
Classification
Each Unit will need to identify how they classify their deviations in terms of severity. As with the naming of deviations, it’s individual unit preference how these are defined, however they will usually follow a similar, escalating severity level.
Here we will use the Major / Minor terminology as a means of classification.
Regardless of the individual classification of any given deviation e.g. a minor deviation, if this is part of a systematic problem, the systematic problem also becomes a deviation of a greater severity. An example is a single missed approved GP letter would be a minor deviation but if the site hasn’t sent the approved GP letters for a large proportion of their patients, but did include details of the trial in a routine clinic letter this could become a major deviation. If the site didn’t include any information about the trial in any communication with the GP and they were completely unaware of their patient’s involvement with the trial, this could be a reportable serious breach if patient safety was/could have been significantly compromised.
Purpose of Recording Deviations
Recording and/or reporting deviations is an important method for maintaining trial oversight, to ensure that the trial is conducted as planned (and approved) and that all participants are comparable within the trial analysis dataset, ensuring that any differences are accounted for/explained in all trial result reports. It’s expected that all major deviations are detailed in the Clinical Study Report (CSR) and/or publication and will be reviewed during any regulatory inspection.
Practically, keeping accurate records and reports of deviations and reviewing these periodically allows Trial Management Groups to identify if there are any significant concerns with trial conduct, at a site, visit or trial level. A suitable and considered CAPA can then be created and implemented, leading to a timely resolution and ultimately limiting the scale of the problem and potential reoccurrence.
The effective dissemination of learning and insights gained through the review of deviations from across the organisation can lead to improved trial design and enhanced trial systems and processes.
