Data Managers

If they work in a clinical trials unit or similar research institution, they will likely be involved in reviewing collected data in a study and checking it for inconsistent or missing data. Alternatively, they might be responsible for adding data from medical notes or other sources onto study forms or systems.

They will usually be involved in designing study forms (e.g. ‘case report forms’ or CRFs). Sometimes they might also be involved specifying or even developing databases and other systems that will be used to collect and manage data in a study, or otherwise use data to support the study.

Data Managers’ role in managing participation changes will focus on collection of good quality data about participation changes to support the running of the study.

Data Managers might therefore be involved in answering questions about whether further data can be collected following different sorts of participation change (based on what the participant said they wanted to do, and other considerations).

They might be responsible for ensuring participants’ wishes are respected when they say they want no further data collection.

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how participation changes can be complex, rather than a simple matter of participants still taking part or having ‘withdrawn’.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. The language people use when discussing participation changes should similarly be clear about how a participant’s involvement has changed. This is a key idea in the PeRSEVERE project, and it’s important that everyone understands it, including Data Managers and those they work with.
• Principle O2 and O3 are relevant when considering what should happen with individual participant changes, and whether further data could be collected. 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. Collecting further data in this situation may not be possible. However, if done in a fair way, it can be acceptable to try to collect more data, or to attempt to recontact participants at the end of a study.
• Principle O5 says that data collection should continue until a participant says they want it to stop, as long as this is done transparently and fairly.
• 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.
• Principles D1 and D2 are about making sure study protocols are clear, flexible and resilient. This can be relevant to Data Managers in knowing the different ways data might be provided by sites or participants, and in writing and/or following protocol instructions about what to do in case of different sorts of participation changes. These principles are also relevant when considering what data to collect, when Data Managers are involved in deciding this. Data Managers might also be involved in discussions around how feasible it might be to collect data in multiple ways or to use multiple schedules within the same study.
• Principle D6 covers adequate training and support to help people manage participation changes. This includes Data Managers, those who work with Data Managers, and those who provide data that Data Managers need to use.
• Principle M1 is particularly important for Data Managers. It says that studies should collect good quality data about participation changes, to make clear how a participant’s involvement has changed, when it changed and – if known – why.
• Some Data Managers might also be involved in central monitoring activities for studies. Principle M2 covers this aspect.

• Our guidance on:
  • 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.
• Checklists for managing individual participation changes, to ensure all required steps are completed.
• Suggested terminology for talking about participation changes (in any context).