GFI: E6(R2) Good Clinical Practice; International Council for Harmonisation

This information collection supports agency guidance. The guidance recommends that sponsors develop and implement a quality management system throughout all stages of the clinical trial process. The guidance also recommends that sponsors describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken in the clinical study report.

The latest form for GFI: E6(R2) Good Clinical Practice; International Council for Harmonisation expires 2023-09-30 and can be found here.

Guidance Recordkeeping Recommendations

Federal Enterprise Architecture: Health - Consumer Health and Safety