ICH Guideline for Good Clinical Practice
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- Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) (PDF,650kb) - Annotated with TGA comments as below
- Replaces: Note for guidance on good clinical practice (CPMP/ICH/135/95)
- Effective: 9 November 2016
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. These guidelines may be overridden by national legal requirements and the requirements of individual regulatory agencies as appropriate, to address matters relevant to local conditions or culture.
In Australia, the National Health and Medical Research Council Act 1992 establishes the 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 (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 TGA has adopted this guideline in principle, but at the same time has recognised that some elements are, by necessity, overridden by the National Statement (and therefore not adopted) and that others require explanation in terms of 'local regulatory requirements'.
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 National Health and Medical Research Council 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 responsibilities, composition, function, operations, procedural and record keeping requirements for Human Research Ethics Committees in Australia are set out in the NHMRC National Statement on Ethical Conduct in Research Involving Humans. The National Statement takes precedence over this document.
Note: currently, an ethics committee needs to have notified its existence to the NHMRC directly.
Section 4.8 - Informed Consent of Trial Subjects
TGA comment: More detailed information about requirements for obtaining informed consent in special cases can be found in the NHMRC National Statement on Ethical Conduct in Human Research.
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.