Depending on the trial risk assessment, it may be useful to plan monitoring activity around individual participation changes.
This could take place during on-site monitoring visits. It could involve review of participants’ medical notes to check that participation has changed in line with participants’ wishes.
Monitoring could help verify that trial sites have followed best practice regarding managing participation changes (including record-keeping, and all other relevant aspects as set out through the PeRSEVERE project).
Implications of changing consent
The impact of participants’ changing consent on trial staff’s access to participants’ medical notes needs to be considered. This access to confidential information is based on participants’ consent, which may not automatically remain in place if participants withdraw their consent to take part in some or all aspects of a trial.
It may be suitable to apply a ‘presumed ongoing consent’ approach to this aspect of participation.*
Central monitoring of individual cases
Central monitoring processes should also help identify where a participant’s wishes have not been followed. For example, if a participant expresses a wish for no further data collection about them for the trial, processes in place at the CTU should immediately identify if the trial site provides trial data (in error) after that time.
* This means participants’ consent to a particular trial activity is presumed to be ongoing if the participant has not said they want that activity to stop, as long as certain conditions are met. For more details, see PeRSEVERE principle O5.