There may be other occasions where it would be useful or necessary to convey information to participants about participation changes.
All communications should be written with an understanding that participation changes can take many forms (see principle O1 – participation can stop, reduce or change).
Contact cards
Sometimes trial participants are given contact cards (or other trial-related information in a similar format, e.g. diary cards for recording when they take their trial intervention).
These could include the message to contact trial staff if they are having any trouble completing any trial activities, or a general message about what to do if they might like to reduce or change their level of participation in the trial.
If any of the additional mechanisms mentioned in ‘Other ways to support freely-given participant decisions‘ have been implemented, then these could be mentioned as well.
Newsletters and other, ongoing communication
Newsletters or other communications provided to participants during their time on trial could remind participants of some of the points covered in the pre-consent information, including about rights to stop taking part, reminders about ‘passive’ aspects of participation such as data collection from routine sources, or the importance of retention and collecting as much of the planned data as possible.
Most content about participation changes needs to be provided up front so that participants can take it into account when deciding whether to take part.
However, it can help reduce the potential for information overload to give different information different emphasis at different times, depending on how relevant it is to participants’ current stage in the trial.
Communicating trial results for all participants
Processes to ensure trial results and other important trial-related information are easy to find on the internet can help address PeRSEVERE principle O7 (information after stopping participation).
This sort of general communication means many participants can more easily find this information regardless of how their participation changed during the trial.