Reference:USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 -
From GxPlex
| Document information | |
|---|---|
| Reference | USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1):
Guidance for Industry March 2018 |
| Validity area | USA |
| Scope(s) | G |
| Document name | FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1):
Guidance for Industry |
| Version / Revision | March 2018 |
| Status | Current |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | GUIDANCE DOCUMENT
E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 â Unit 1.3.0 |
| Scope | G |
| Document part | - |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Good clinical practice, FDA, Clinical trial |
| Comment | FDA guidance document: GCP for clinical trials |
Content
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page.
