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E8(R1) Draft Guideline: ICH


24th June 2019

In May 2019, the ICH E8(R1) draft guideline on General Considerations for Clinical Trials reached Step 2b of the ICH process and entered the period of public consultation. ICH E8’s modernization is the first step towards the GCP Renovation initiated in 2017.

The modernization of ICH E8 is proposed to incorporate the most current topics achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials. The revision promises to:

  • · Identification and adaption of critical-to-quality factors to support trial results and to protect human subjects;
  • · Addressing broader range of trial designs and data sources;
  • · Provide cross-referencing of all relevant ICH guidelines.

The ICH draft covers GENERAL PRINCIPLES, DESIGNING QUALITY INTO CLINICAL STUDIES, DRUG DEVELOPMENT PLANNING, DESIGN ELEMENTS FOR CLINICAL STUDIES, STUDY CONDUCT AND REPORTING, and CONSIDERATIONS IN IDENTIFYING CRITICAL-TO-QUALITY FACTORS along with their sub-topics.

It also includes 3 Annexes: Annex 1 (TYPES OF STUDIES), Annex 2 (ICH E FAMILY OF GUIDELINES) and Annex 3 (SELECTED EXAMPLES OF CRITICAL-TO-QUALITY FACTORS).


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