EMA has published a revision of the ICH-E8 Guideline for consensus building: GENERAL CONSIDERATIONS FOR CLINICAL STUDIES.
This version is a revision of the original E8 guideline from 1998. It covers topics like
- General principles (protection of subjects, scientific approach and patient input)
- Designing quality into clinical studies
- Drug development planning
- Design elements for clinical studies
- Conduct and reporting
- Considerations in identifying critical to quality factors
Please find here the link to the EMA webpage:
EFGCP would like to submit comments - critique and constructive suggestions – on topics of relevance to our vision and mission. All members are free to send their own comments to EMA but it is believed that the comments will have a higher weight if presented under the EFGCP banner.
Ingrid Klingmann, MD, PhD
Healthcare professionals who wish to be part of a unique network, providing access to up-to-date, accurate and validated information about clinical research.
Investigators and study staff who wish to be part of a unique network, in order to stay abreast of clinical trials taking place in Luxembourg and who are willing to further develop their competencies.