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

ICH E6(R3) Guideline

1.1

Submission and Communication

For the submission to or communication with the IRB/IEC, in most regions where there is also a requirement to make a submission to the relevant regulatory authority, these may be combined in a single submission in accordance with applicable regulatory requirements. Submissions and communications with the IRB/IEC and regulatory authorities are made in some regions by the investigator/institution and by the sponsor in other regions in accordance with applicable regulatory requirements.

1.2

Responsibilities

1.2.1

The purpose of an IRB/IEC is to safeguard the rights, safety and well-being of all trial participants. Appropriate consideration should be given to trials that intend to recruit vulnerable participants.

1.2.2

The IRB/IEC should review the following information, where applicable:

(a)

Protocol and amendments;

(b) Informed consent material(s), assent material(s), where applicable, and any updates, including the description of the process for how informed consent and assent is to be obtained; (c) Investigator ’ s Brochure or current scientific information, such as a basic product information brochure (e.g., Summary of Product Characteristics (SmPC), package leaflet or labelling), as appropriate, including their updates; (d) Other trial-related information to be provided to the trial participant(s), including a description of the media through which such information will be provided;

(e) Advertisement for participant recruitment (if used) and information on the recruitment process;

(f)

Plans to compensate participants (if any);

(g)

Ongoing updates to safety information;

(h) I nvestigator’s current curriculum vitae and/or other documentation evidencing qualifications;

(i) Any other documents that the IRB/IEC may need to fulfil its responsibilities.

1.2.3

The IRB/IEC should review a proposed clinical trial within a reasonable time and document its reviews, clearly identifying the trial, the documents reviewed and the dates for the following:

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