2.5.1 The investigator/institution should sign the protocol or an alternative contract to confirm agreement with the sponsor.
2.5.2 The investigator should comply with the protocol, GCP and applicable regulatory requirements.
2.5.3 The investigator should document all protocol deviations. In addition to those identified by the investigator themselves, protocol deviations relevant to their trial participants and their conduct of the trial may be communicated to them by the sponsor (see section 3.11.4.5.1(b)). In either case, the investigator should review the deviations, and for those deviations deemed important, the investigator should explain the deviation and implement appropriate measures to prevent a recurrence, where applicable (see section 3.9.3).
2.5.4 The investigator should follow the protocol and deviate only where necessary to eliminate an immediate hazard(s) to trial participants. In case of deviations undertaken to eliminate immediate hazard to trial participants, the investigator should inform the sponsor promptly.
2.5.5 The investigator should report information on the immediate hazard, the implemented change and the subsequent proposed protocol amendment, if any, to the IRB/IEC and, where applicable, regulatory authorities