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
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference: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 | ||
| Reference:ICH ICH E8 Guideline R1 (2021) - | HM | - | EN | ICH guideline E8 (R1) on general considerations for clinical studies |
| Reference: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 operationally feasible. A feasibility assessment ... |
| Reference: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 conditions under a shared framework. Platform studies ... |
| Reference: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 criteria for the study The degree to which a study ... |
| Reference: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 documented in the clinical study protocol. […] |
| Reference: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. Therefore, if a study includes one or more interim ... |
| Reference: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 to ensure the protection of the participants but ... |
| Reference: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 enrolled in a clinical study, or a participant becomes ... |
| Reference: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 E9). In studies with planned interim analyses, ... |
