What is the Persevere project about?
The PeRSEVERE principles aim to guide everyone involved in research about how to prepare for and manage “participation changes” – this means when research participants stop, reduce, change or increase their involvement in a study, whatever the circumstances.
Participation changes can be complex, and our principles aim to give everyone clarity and confidence about the right approach.
What might be a Monitor’s role in helping to manage participation changes in research studies?
A study monitor may be mostly responsible for planning, carrying out and following-up on visits to study sites.
They might be involved in reviewing data about participation changes before visits, to help plan the visit or to decide which sites to visit as part of a ‘triggered’ monitoring approach.
At the visit, they might review information about individual participation changes, for example checking the evidence in the participant’s medical notes to confirm the change has been reported correctly. As this access to medical notes is based on participants’ consent, monitors should be clear about when that consent is still in place and when it is not.
Some monitors may also be involved in ‘central monitoring’ of data about participation changes, to review trends without necessarily planning a visit.
Which PeRSEVERE principles might be most relevant?
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how participation changes can be complex, rather than a simple matter of participants still taking part or having ‘withdrawn’.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 Monitors and those they work with.
- Principle O2 says that the extent and nature of participation changes should be primarily each participant’s informed and freely-given choice. Monitors can check at on-site visits that there is evidence that participation has changed in line with participants’ wishes (no more, no less).
- Principle O5 says that data collection should continue until a participant says they want it to stop. We explain the conditions that make this fair and transparent. These same ideas of ‘presumed ongoing consent’ can be applied to other aspects of participation, as long as those same conditions are met – including access to medical records for monitoring purposes.
- Principle D2 is about making sure the study protocol has clear instructions about managing participation changes. This is relevant to monitors who need to follow any of those instructions themselves, or check that they have been followed at sites.
- Principle D6 covers adequate training and support to help people manage participation changes. This includes Monitors but also those who might work with Monitors or who are trained by them.
- Principle M1 is about the importance of good quality data about participation changes, which can support study management and analysis. Monitors can have a role in this through checking that data reported to their research institution is accurate, based on data available at on-site visits. Good quality data also supports Monitors to choose the right sites to visit, and to carry out their visits with the best available information.
- Principle M2 is about monitoring of participation changes. This includes central monitoring, to look for trends in participation changes overall, or by site or by type of change. It also includes on-site monitoring, where monitors might look at how individual participation changes have been managed.
Which PeRSEVERE resources might be most useful?
- Our guidance on:
- Suggested terminology for talking about participation changes (in any context).