2.6 Premature termination or suspension of a trial

2.6.1 If the trial is prematurely terminated or suspended for any reason, the investigator/institution should promptly inform the trial participants and should ensure appropriate therapy and follow- up for the participants.

2.6.2 Where the investigator terminates or suspends their involvement in a trial without prior agreement by the sponsor, the investigator should promptly inform the institution, where applicable, the sponsor, the IRB/IEC and the regulatory authorities in accordance with applicable regulatory requirements and should provide a detailed explanation of the reasons.

2.6.3 If the sponsor terminates or suspends a trial, the investigator/institution or the sponsor, in accordance with applicable regulatory requirement(s), should promptly inform the IRB/IEC and the regulatory authorities and should provide an appropriate explanation (see section 3.17.1).

2.6.4 If the IRB/IEC terminates or suspends its approval/favourable opinion of a trial (see sections 1.2.3 and 1.4.9), the investigator should inform the institution, where applicable, and the investigator/institution should promptly notify the sponsor.

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