Policies and processes

Managing participation changes through organisational policies:

• Consider referencing the PeRSEVERE principles if you agree these should guide how participation changes are managed in your organisation.
• Consider adopting a ‘presumed ongoing consent’ approach to study data collection and/or other aspects of study participation. This means that participants can say they do not want data collection to continue, but it will continue unless and until they do express such a wish, even if their participation reduces or changes in other ways (subject to the conditions set out in PeRSEVERE principle O5).
• Confirm that data already collected until a participant says they want data collection to stop will be retained, and made available at the end of the trial for secondary research purposes.
• Alongside these points, remind staff that each participant’s situation needs to be assessed on its own features, and the policy positions should not be applied in a blanket manner without further thought.

Standard Operating Procedures (SOPs) about participation changes:

• SOPs should reinforce the message that study participation changes can take many forms, and guide CTU staff on how to manage this complexity.
• SOPs can list the decisions to make and document for each study, including:
  • Whether aspects of participation will be formally organised into tiers or levels for practical reasons.
  • What level of flexibility may be acceptable regarding what the protocol requires participants to do (e.g. in follow-up schedules).
  • Whether there are any alternative follow-up or data collection mechanisms or schedules.
  • How to manage loss of contact between participants and researchers.
  • Any study-specific considerations affecting the general principle that data already collected is retained.
  • Any study-specific aspects to which a ‘presumed ongoing consent’ approach might be applied (see above).
  • Study-specific processes to help record and maintain information about participants’ contact details and preferences.
  • Any specific features of the study that could make handling participation changes more difficult, for example in an international context.
• SOPs can list the key information to be communicated to potential study participants about changing their participation.
• SOPs should outline the general steps to take when participants express a wish to stop, reduce or change their participation.
• SOPs should be clear about the need to complete enough statistical planning before a study starts recruitment, including how the study analysis will be done in ways that give the best chance of a reliable result despite participation changes.
• SOPs should state the general position that data already collected at the time a participant says they want data collection to stop is retained and analysed.
• SOPs could also confirm that, in general, data generated prior to a participant’s decision to stop data collection can still be collected.
• Where data collection is to fulfil a regulatory requirement, SOPs should state that collection of these sorts of data continues indefinitely (e.g. collection of some safety data in clinical trials of investigational medicinal products).
• SOP content regarding the emergence of new information about study interventions’ safety should include the requirement to decide whether the new information may need to be shared with all participants, including those who have stopped participating in the study.
• SOPs about sharing study results with participants (and any other routine participant communications) should be clear that stopping participation does not automatically exclude participants from receiving such information.