Integrated addendum to ICH E6(R1): guideline for good clinical practice E6(R2)

About this guideline

Overseas effective date: 9 November 2016

Replaces: Note for guidance on good clinical practice (CPMP/ICH/135/95)

Categories: Clinical efficacy and safety | General 

TGA Annotations: 

Introductory comments of the TGA

The Guideline for Good Clinical Practice is an internationally accepted standard for the designing, conducting, recording and reporting of clinical trials. The Guideline for Good Clinical Practice is incorporated by reference in the Therapeutic Goods Regulations 1990. Compliance with the Guideline is a condition of approval for the conduct of a clinical trial.

In Australia, the National Health and Medical Research Council Act 1992 establishes the National Health and Medical Research Council (NHMRC) as a statutory entity to pursue and foster issues relating to public health. The NHMRC is specifically required to issue guidelines for the conduct of medical research and ethical matters related to health. The National Statement on Ethical Conduct in Human Research- external site (the National Statement) has been produced by the NHMRC as the Australian ethical standard against which all research involving humans, including clinical trials, are reviewed. The National Statement is incorporated by reference in the Therapeutic Goods Regulations 1990. Compliance with the National Statement is a condition of approval for the conduct of a clinical trial.

If requirements specified in the National Statement appear to differ from those specified in the Guideline for Good Clinical Practice, the TGA recommends compliance with the National Statement.

Section 3 INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)

TGA comment: The Therapeutic Goods Act 1989 defines an ethics committee as a committee constituted and operating in accordance with guidelines issued by the NHMRC as in force from time to time; and which has notified its existence to the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992. The ethics committee must notify their existence to the NHMRC directly. The responsibilities, composition, function, operations, procedural and record keeping requirements for Human Research Ethics Committees in Australia are set out in the National Statement. To the extent that there is a perceived inconsistency between the National Statement and the Guideline for Good Clinical Practice, the TGA recommends that the National Statement take precedence.

Section 4.8 - Informed Consent of Trial Subjects

TGA comment: Further information about requirements for obtaining informed consent in special cases can be found in the National Statement.

Section 5.2.2 - Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing

TGA comment: The Australian trial sponsor retains overall responsibility for the conduct of the trial in Australia.

Section 5.5.11 – Trial Management, Data Handling, and Record Keeping

TGA comment: The TGA requires records to be retained by the trial sponsor for at least 15 years following the completion of a clinical trial. However, in Australia, the overriding consideration for trial sponsors with respect to record retention is the issue of product liability and the potential need for sponsors of products to produce records at any time during, and possibly beyond, the life of a product in the event of a claim against the sponsor as a result of an adverse outcome associated with the use of the product.

Section 5.13 - Manufacturing, Packaging, Labelling, and Coding Investigational Product(s)

TGA comment: The 'applicable GMP' in Australia refers to the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (in particular Annex 13) and the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products.

Section 5.17 – Adverse Drug Reaction Reporting

TGA comment: The TGA has adopted the 'ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting' in principle, particularly its reporting timeframes. Trial sponsors should refer to the guidance published by the NHMRC: Safety monitoring and reporting in clinical trials involving therapeutic goods- external site.

For more information see International scientific guidelines adopted in Australia.