ICH Harmonised Guideline for Good Clinical Practice E6(R3) - Step 4 Final

ICH E6(R3) Guideline

Unfavourable medical events occurring in participants before investigational product administration (e.g., during screening) should be considered and reported to the sponsor if required by the protocol.

(b) All serious adverse events (SAEs) should be reported immediately (after the investigator reasonably becomes aware of the event) to the sponsor. The investigator should also include an assessment of causality. In accordance with applicable regulatory requirements, the protocol may identify SAEs not requiring immediate reporting; for example, deaths or other events that are endpoints. Subsequent information should be submitted as a follow-up report, as necessary. (c) For reported deaths, the investigator should supply the sponsor, the IRB/IEC and, where applicable, the regulatory authority with any additional requested information (e.g., autopsy reports and terminal medical reports) when they become available. (d) The investigator may delegate activities for safety reporting to qualified investigator site staff but retains the overall responsibility for safety of participants under their responsibility and compliance with the reporting requirements. In obtaining and documenting informed consent (paper or electronic format), the investigator should comply with the applicable regulatory requirement(s) and should adhere to GCP and to the ethical principles that have their origin in the Declaration of Helsinki. The informed consent process should include the following: (a) Prior to consenting and enrolling participants, the investigator should have the IRB/IEC ’ s documented approval/favourable opinion of the informed consent materials and process; (b) The information should be as clear and concise as possible, use simple language and avoid unnecessary volume and complexity. This is to ensure that the trial participants or their legally acceptable representatives have an adequate understanding of the objectives of the trial, alternative treatments, potential benefits and risks, burdens, their rights and what is expected of the participants to be able to make an informed decision as to their participation in the trial; (c) Varied approaches (e.g., text, images, videos and other interactive methods) may be used in the informed consent process including for providing information to the participant. The characteristics of the potential trial population (e.g., participants may lack familiarity with computerised systems) and the suitability of the method of obtaining consent should be taken into consideration when developing the informed consent materials and process. When computerised systems are used to obtain informed consent, trial Informed Consent of Trial Participants

2.8

2.8.1

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