OMB control number
GFI: E6(R2) Good Clinical Practice; International Council for Harmonisation
OMB 0910-0843 · HHS/FDA.
OMB 0910-0843
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 is listed under ICR 202008-0910-009.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 Guidance Reporting Recommendations |
Information collection |
| Guidance Recordkeeping Recommendations |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202008-0910-009 | Extension without change of a currently approved collection | 2020-08-10 | Approved without change | |
| 201707-0910-011 | New collection (Request for a new OMB Control Number) | 2017-07-18 | Approved without change |
OMB Details
Guidance Recordkeeping Recommendations
Federal Enterprise Architecture: Health - Consumer Health and Safety