2.9.1 When a participant decides to stop treatment with the investigational product or withdraw from a trial; is discontinued from the trial; or reaches the routine end of the trial, the investigator should follow the protocol and/or other protocol-related documents. For participants who did not reach the routine end of the trial, this may include instructions to avoid loss of already collected data, in accordance with applicable regulatory requirements, to ensure that trial results are reliable. In general, loss of already collected data may bias results and may lead to, for example, inaccurate conclusions regarding the safety profile of the investigational product.
2.9.2 Although a participant is not obliged to provide a reason(s) for withdrawing prematurely from a trial, the investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the participant’s rights. The investigator should consider if a discussion with the participant or the participant’s legally acceptable representative is appropriate. This discussion should focus on the reasons for withdrawal to determine if there are ways to address the concerns such that the participant could reconsider their withdrawal without unduly influencing the participant’s decision. The investigator or delegated investigator site
staff should consider explaining to the participant the value of continuing their participation to minimise trial participants withdrawal. In this process, the investigator should ensure that it does not interfere with the participant’s decision to refuse or withdraw participation at any time.
2.9.3 Where relevant, the investigator should inform the participant about the trial results and treatment received when this information is available from the sponsor after unblinding, with due respect to the participant’s preference to be informed.