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If you have read the Note for Guidance on Good Clinical Practice (CPMP/ICH/13e72_05/95) – Annotated with TGA comments, you would be aware that Section 3 – Institutional Review Board/Independent Ethics Committee is not included.  This is because the TGA has adopted the NRMC’s National Statement on Ethical Conduct in Research (often referred to simply as The National Statement) in place of Section 3 of ICH-GCP.

The National Statement is not often taught as part of a GCP course but it is important for researchers to be as familiar with this document as they are with other sections of GCP.  All members of your research team, members of the HREC and personnel involved in research governance should all be familiar with this document.

But perhaps the most important group of people who should be familiar with this document are clinical research participants.  Unfortunately, the NHMRC no longer prints hard copies of this document but it can be easily downloaded form their website.

 

 

Affinity Clinical Research Services Newsletter

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