Trial/Study Managers

They might help write the sections of a study protocol that are about managing participation changes or the relevant sections of pre-study information for potential study participants.

They might work with recruiting study sites to help manage individual participant changes in a timely way, for example helping to establish what a participant wants to do, and how their involvement in a study should change. This involves considering the participants’ rights and wishes, and also what is in the best interests of the study (and therefore the patients in future who will be affected by the study results).

They might be involved in centrally monitoring trends in participation changes at oversight committee meetings. They might be responsible for sharing study results with the participants, including those who stopped taking part if they still want to receive the results.

The principles are coded with O for ‘overarching’ principles, D for study design and setup issues, M for data management and monitoring, and R for study analysis and reporting. See the main PeRSEVERE principles page for more details.

• The principle O1 explains how participation changes can be complex, rather than a simple matter of participants still taking part or having ‘withdrawn’. Often, there might be various ways that participants might change their involvement in a study. This is a key idea in the PeRSEVERE project, and it’s important that everyone understands it, including Trial/Study Managers and those they work with.
• Principle O2 and O3 are relevant when considering what should happen with individual participant changes. O2 says that the participant’s wishes about how their participation will change should come first. O3 says that everyone involved in managing participation changes should keep in mind that it is good for studies to collect as much of the planned data as possible, particularly study outcome data.
• Principle O4 gives guidance about what to do if participants and research staff lose contact – which is not the same as participants saying they want to stop taking part.
• Principles O5 and O6 are about when further data collection about participants should continue or stop, and about keeping data already collected.
• Principle O7 says that stopping taking part in a study does not mean participants cannot get information they want or need later on. This includes study results, if they still want to receive them.
• Principles D1 and D2 are about writing clear, flexible and resilient study protocols that are also feasible to run. The principles also emphasise the importance of being proactive, and working with patient contributors to ensure protocols are suitable.
• Principles D3 and D4 are about how to create clear and balanced information for potential research participants about changing their participation.
• Principle D6 covers adequate training and support to help people manage participation changes. This includes Trial/Study Managers but also those who might receive training from Trial/Study Managers.
• Principles M1 and M2 say we need to collect good quality data about participation changes to inform study management, and that we should use that data to monitor the number and nature of participation changes in ongoing studies. Monitoring might lead to protocol amendments, which Trial/Study Managers would usually be involved in.

• Our guidance on:
  • Grant applications and protocol development
  • Patient information, participant communications and consent
  • Risk assessments and monitoring
  • Training and support
  • Data collection about participation changes

• Example scenarios showing how the PeRSEVERE principles can help manage – or avoid – various issues relating to participation changes.
• Guidance on providing information to participants around the time they stop or reduce their participation.
• Template wording for study patient information sheets.
• Suggested terminology for talking about participation changes (in any context).