Training and support

Training of clinical trials unit staff:

• In the pages of this section, we give detailed recommendations for how to ensure trials unit staff are trained and supported to manage study participation changes for the good of participants and studies.

Training and support for study sites:

• We suggest that more detailed training for study site staff about managing participation changes would be a good addition to existing training that staff already routinely receive.
• We make recommendations for training content:
  • The main messages from the PeRSEVERE project, with rationale.
  • Opportunities for study site staff to talk through any concerns, misunderstandings or disagreements with these main messages.
  • Recognition that it can be challenging to accommodate the needs of study participants and the studies they take part in.
  • The need for all involved in studies (in any capacity) to understand the potential complexity in participation changes and to use language and terminology to match.
  • The importance of collecting as much of the planned data as possible, with a particular focus on study outcome data.
  • The idea that study data collection continues until the participant says they want it to stop, the conditions that need to apply to make this approach valid, and the role of study site staff in applying the approach.
  • Confirmation that, if a participant does say they want data collection to stop, data already collected is retained and data generated prior to that point can also still be collected in most cases.
  • Information to convey during initial consent about participation changes.
  • Encouragement to have dialogue wherever needed about participation changes, both with participants and with CTUs (to discuss individual cases or to seek advice).
  • Emphasis on communication with participants being balanced and positive, i.e. there is no ‘wrong choice’ for participants about their level of involvement in the study.
  • Advice about how to talk to participants about topics where staff may worry about the risk of appearing to put pressure on participants.
  • Confirmation that study staff should assess each individual situation for its specific circumstances and sensitivities, and prioritise participants’ rights.
  • Emphasising that when a participant says they want to stop or reduce their participation, it does not mean they need to stop all involvement.
  • Emphasising that the nature and extent of participation changes should be participants’ decision.
  • The need to explore whether a change in study site could help the participant continue contributing to the study, if they want to.
  • Guidance and expectations for establishing what a participant wants to do when they say they want to stop or reduce their participation.
  • Information about possible flexibilities in each study’s follow-up procedures.
  • Reminders to communicate clearly with participants if aspects of participation stop when it was not participants’ choice.
  • Expectations around record-keeping for all types of participation change.
  • What is practically expected of study staff in cases where they are unable to contact research participants.
  • Advice about how to ask participants if they might be happy to provide any information about why they want to change their participation.
  • Advice about how to ask participants if they are willing to provide study outcome data when they stop or reduce their participation (if it would help the trial’s objectives).
  • Confirmation that stopping participation does not automatically remove participants’ rights to receive relevant information that they might want or need.
  • It may be useful to present common scenarios that may arise and what would be expected from study staff in these scenarios.
• We make further suggestions for how study site staff could be better supported to manage participation changes. We provide examples of tools and templates that could help with this, such as checklists for managing different sorts of participation change, templates to use when attempting to regain contact with participants or to check participants’ preferences for further contact.