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title: "Good clinical practice"
canonical: "https://research.refined.site/space/Research/112492591/Good%20clinical%20practice"
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[International Conference on Harmonisation - Good Clinical Practice (ICH GCP) – E6 (R3)](https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf) 

- The first version of the ICH E6 Good Clinical Practice (GCP) Guideline was finalised in 1996, outlining the responsibilities and expectations of all participants involved in the conduct of clinical trials, including investigators, monitors, sponsors, and ethics committees/IRBs. GCP addresses key elements such as trial design, conduct, monitoring, reporting, and archiving, and includes guidance on essential documents and the Investigator’s Brochure.
- In 2016, the guideline was updated with the integrated addendum E6(R2), which introduced a greater emphasis on risk-based approaches to trial design, conduct, and oversight. This update encouraged more efficient and quality-focused clinical trial processes while maintaining robust protection of participants and the integrity of trial data. It also strengthened expectations around electronic systems, data governance, and the management of essential documents.
- The guideline has since undergone further modernisation with the development of E6(R3). As of 2024–2025, E6(R3) has been finalised and adopted in multiple regions. This revision represents a significant evolution of GCP, introducing a principles-based and flexible framework designed to accommodate increasingly diverse trial designs, data sources, and technological innovations. E6(R3) places stronger emphasis on quality by design, proportionate risk management, fit-for-purpose processes, and the use of digital technologies, while continuing to ensure the protection of trial participants and the reliability of results. It also expands applicability beyond traditional interventional trials to a broader range of clinical study types used to support regulatory and healthcare decision-making.
- All researchers should complete ICH GCP training at least every 3 years


**ICH-GCP Training Courses**

Training provider options may be fee based or free / face to face or online.

For example:

Free Online: Global Health Network **[ICH Good Clinical Practice E6 (R3)](https://globalhealthtrainingcentre.tghn.org/ich-gcp-r3/)**

Recognised by TransCelerate BioPharma as meeting the minimum criteria for ICH GCP Investigator Site Personnel Training necessary and mutually accepted by trial sponsors

Fee based and face to face: Green Lane Coordinating Centre [Good clinical practice (GCP) courses](http://www.glcc.co.nz/gcp-training) 

Should you require to be trained in shipping blood or tissue samples for a clinical trial, please contact Te Whatu Ora Waitematā Laboratory Quality Manager to enquire about the next **IATA Infectious Substances by Air** course.


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###### Last reviewed May 2026   
Author: Kathryn Tennant