Trial Withdrawal
This section contains
the following:
Introduction
Participants should have been informed, when consenting to take part
in the study, about their right to abstain from participation in a
study or withdraw consent to participate at anytime. If they do decide
to withdraw they are not required to give a reason. However, it
is important to establish with the participant the status of data all
ready collected. A conversation with the trial participant may
help to explain why the data all ready collected is important but this
is ultimately the decision of the participant.
In the case of centre withdrawal this will be due to the recruitment
period finishing or because of early termination of the trial (see trial
closure).
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Things to
consider
- Ensure the investigator site manual documents the
procedure to be followed if a participant withdraws.
- Depending on the type of study it maybe that the
participant only wants to withdraw from part and not all of the study.
It is important to make sure that this is clearly documented and
understood.
- Ensure that the appropriate documentation is completed
and the coordinating centre is informed.
- Try to inform the coordinating centre promptly so that
inadvertent further contact does not occur if not appropriate.
- Special consideration should be given to participant
withdrawal due to Serious
Adverse Events.
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This page was last updated January 2009.