Quality Assurance staff

Quality Assurance staff might be responsible for developing standard operating procedures and templates that help study teams manage participation changes.

They might also be involved in assessing individual cases – especially more complex ones – to establish how a participant’s involvement should change based on what the participant has said they want, for example whether further data can be collected or biological samples retained.

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how participation changes can be complex, rather than a simple matter of participants still taking part or having ‘withdrawn’.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 QA staff and those they work with.
• Principle O2 says that it’s mainly participants who decide the nature and extent of changes in their participation.
• Principle O3 says that everyone involved in studies should be aware that it’s good to collect as much as possible of the planned study data. This doesn’t mean this overrides all other considerations, but it should be taken into account in all work related to managing participation changes.
• 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.
• Principle O5 supports study quality by saying that data collection continues until a participant says they want it to stop. We set out some conditions for how to apply this approach fairly and transparently.
• Principle O6 confirms that data already collected before a participant says they want data collection to stop should be kept and used in study analysis. In many cases, this also includes data gathered before that time but not yet added to study forms.
• 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.
• Principle D6 says that everyone involved in managing participation changes should be adequately trained and supported to do it. Quality Assurance staff might be involved in providing that training.
• Principle M2 is about monitoring and oversight of participation changes. Monitoring activity should be informed by study risk assessments.

• Our guidance on:
  • Policies and processes
  • Risk assessment and monitoring
  • Training and support

• Scenarios explaining how the Persevere principles can help.
• Suggested terminology for talking about participation changes (in any context).
• Template patient information sheet wording.