EMA-consult: ICH-richtlijn E8 (R1) over algemene overwegingen voor klinische onderzoeken – Stap b

The European Medicines Agency has released for public consultation an ICH guideline E8 (R1) on general considerations for clinical studies – Step b.

The ICH guideline ‘General considerations for clinical studies’ is intended to describe internationally accepted principles and practices in the design and conduct of clinical studies that will facilitate acceptance of data and results by regulatory authorities, provide guidance on the consideration of quality in the design and conduct of clinical studies across the product lifecycle, including the identification during study planning of factors that are critical to the quality of the study, and the management of risks to those factors during study conduct. It provides an overview of the types of clinical studies performed during the product lifecycle, and describe the aspects of those studies that support the determination of which quality factors are critical to ensuring the protection of study subjects, the integrity of the data, the reliability of results, and the ability of the studies to meet their objectives.

The draft guideline is available by clicking here.

Comments should be provided using this template and sent to ich@ema.europa.eu by 30 September 2019.

Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.

For more information on the European regulatory system for medicines, please click here (brochure available in all languages).