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

ICH E6(R3) Guideline

The sponsor should consider whether the protocol requires amendment in response to an immediate hazard. The information on the immediate hazard, if required, and any subsequent protocol amendment should be submitted to the IRB/IEC and/or regulatory authorities by the investigator/institution or sponsor (in accordance with applicable regulatory requirements).

3.14

Insurance/Indemnification/Compensation to Participants and Investigators

3.14.1

If required by the applicable regulatory requirement(s), the sponsor should provide insurance or should indemnify (legal and financial coverage) the investigator/the institution against claims arising from the trial except for claims that arise from malpractice and/or negligence. The sponsor ’ s policies and procedures should address the costs of treatment of trial participants in the event of trial-related injuries in accordance with the applicable regulatory requirement(s).

3.14.2

3.14.3

The approach to compensating trial participants should comply with applicable regulatory requirement(s).

3.15

Investigational Product(s)

3.15.1

Information on Investigational Product(s)

The sponsor should ensure that an I nvestigator’s Brochure is developed and updated as significant new information on the investigational product becomes available. Alternatively, for authorised medicinal products, the sponsor should identify the basic product information to be used in the trial (see Appendix A, section A.1.1).

3.15.2

Manufacturing, Packaging, Labelling and Coding Investigational Product(s)

(a) The sponsor should ensure that the investigational product(s) (including active control(s) and placebo, if applicable) is characterised as appropriate to the stage of development of the product(s), is manufactured in accordance with any applicable GMP and is coded and labelled in a manner that protects the blinding, if applicable. In addition, the labelling should comply with applicable regulatory requirement(s). (b) The sponsor should determine acceptable storage temperatures, storage conditions (e.g., protection from light) and shelf life for the investigational product(s), appropriate reconstitution fluids and procedures, and devices for product administration, if any. The sponsor should inform all involved parties (e.g., monitors, investigators, pharmacists, storage managers) of these determinations.

(c) The investigational product(s) should be packaged to prevent contamination and unacceptable deterioration during transport and storage.

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