# E8(R1) General Considerations for Clinical Studies - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/e8r1-general-considerations-for-clinical-studies/c5e52286-b058-4b0f-b1f2-e589be1aaf84

> FDA guidance document: E8(R1) General Considerations for Clinical Studies. Issue date: April 08, 2022. Get complete insights and analysis.

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## Details

- Title: E8(R1) General Considerations for Clinical Studies
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2022-04-08
- Last Changed: 2022-04-08
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-3049">FDA-2019-D-3049</a>

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