Document:ICH ICH E8 Guideline R1 (2021)
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| Document information | |
|---|---|
| Reference | ICH ICH E8 Guideline R1 (2021) |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E8 Guideline |
| Version / Revision | R1 (2021) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | ICH guideline E8 (R1) on general considerations for clinical studies |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| ICH ICH E8 Guideline R1 (2021) - | HM | - | EN | ICH guideline E8 (R1) on general considerations for clinical studies… |
| ICH ICH E8 Guideline R1 (2021) 3.3.5 | HM | 3.3.5 | EN | 3.3.5 Critical to Quality Factors in Operational Practice The foundation of a successful study is a protocol that is both scientifically sound and ope… |
| ICH ICH E8 Guideline R1 (2021) 4.3.3.1 | HM | 4.3.3.1 | EN | 4.3.3.1 Investigations in pregnant women Investigation of drugs that may be used in pregnancy is important. Where pregnant women volunteer to be enrol… |
| ICH ICH E8 Guideline R1 (2021) 5. | HM | 5. | EN | 5. DESIGN ELEMENTS AND DATA SOURCES FOR CLINICAL STUDIES
[…] Master protocol studies allow for the investigation of multiple drugs or multiple conditi… |
| ICH ICH E8 Guideline R1 (2021) 5.1 | G | 5.1 | EN | Study Population The population to be studied should be chosen to support the study objectives and is defined through the inclusion and exclusion crit… |
| ICH ICH E8 Guideline R1 (2021) 5.6 | HM | 5.6 | EN | 5.6 Statistical Analysis
[…] For double-blind studies, the statistical analysis should be finalised before treatment assignments are revealed. Therefo… |
| ICH ICH E8 Guideline R1 (2021) 6.1.4 | HM | 6.1.4 | EN | 6.1.4 Access to Interim Data Inappropriate access to data during the conduct of the study may compromise study integrity (Sections 5.5 and 5.6 and ICH… |
| ICH ICH E8 Guideline R1 (2021) 6.2.2 | HM | 6.2.2 | EN | 6.2.2 Withdrawal Criteria Clear criteria for stopping treatment or study procedures for a study participant while remaining in the study are necessary… |
| ICH ICH E8 Guideline R1 (2021) 7 | G | 7 | EN | Consideration in identifying critical to quality factors
[…] The eligibility criteria should be reflective of the study objectives and be well documen… |
| ICH ICH E8 Guideline R1 (2021) ANNEX: TYPES OF CLINICAL STUDIES | HM | ANNEX: TYPES OF CLINICAL STUDIES | EN | „Human Pharmacology“
„Exploratory“ „Confirmatory“ „Post-Approval“ https://www.ich.org/page/efficacy-guidelines… |
