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

ICH E6(R3) Guideline

(a) Deviations from the protocol to eliminate immediate hazards to the trial participants (see sections 1.4.7, 2.5.4 and 2.5.5);

(b) Changes increasing the risk to participants and/or significantly affecting the conduct of the trial (see section 2.4.6);

(c) All suspected unexpected serious adverse reactions (SUSARs) in accordance with applicable regulatory requirements;

(d) New information that may adversely affect the safety of the participants or the conduct of the trial.

1.4.9

Ensuring that the IRB/IEC (see section 1.1) promptly notifies in writing (paper or electronically) the investigator/institution or sponsor concerning:

(a)

Its trial-related decisions/opinions;

(b)

The reasons for its decisions/opinions;

(c)

Procedures for appeal of its decisions/opinions.

1.5

Records

1.5.1

The IRB/IEC should retain all relevant records (e.g., documented procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings and correspondence) in accordance with applicable regulatory requirements and make them available upon request from the regulatory authority(ies).

1.5.2

The IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide its documented procedures and membership lists.

2.

INVESTIGATOR

2.1

Qualifications and Training

2.1.1

The investigator(s) should be qualified by education, training and experience to assume responsibility for the proper conduct of the trial and should provide evidence of such qualifications. The investigator should be familiar with the appropriate use of the investigational product(s) as described in the protocol, in the current Investigator ’ s Brochure, in the product information and/or in other information sources provided by the sponsor.

2.1.2

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