ICH E8 General Considerations for Clinical Trials
E555142
ICH E8 General Considerations for Clinical Trials is an international guideline that outlines fundamental principles and quality considerations for the design, conduct, and evaluation of clinical studies across all phases of drug development.
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
ICH guideline
ⓘ
clinical trial guideline ⓘ regulatory guidance document ⓘ |
| abbreviation | ICH E8 NERFINISHED ⓘ |
| addresses |
ethical conduct of clinical trials
ⓘ
protection of trial subjects ⓘ quality by design in clinical development ⓘ reliability of clinical trial data ⓘ risk-based approach to clinical trial quality ⓘ scientific validity of clinical trials ⓘ |
| aimsTo |
facilitate global drug registration
ⓘ
harmonise clinical trial requirements internationally ⓘ improve quality of clinical development programs ⓘ |
| appliesTo |
all phases of clinical drug development
ⓘ
confirmatory clinical trials ⓘ exploratory clinical trials ⓘ post-approval clinical studies ⓘ |
| covers |
blinding and randomisation
ⓘ
choice of endpoints ⓘ control groups and comparators ⓘ data handling and record keeping ⓘ monitoring and quality assurance ⓘ multinational clinical trials ⓘ selection of trial population ⓘ special populations in clinical trials ⓘ |
| emphasizes |
critical-to-quality factors in clinical trials
ⓘ
patient safety and rights ⓘ proportionate trial oversight ⓘ prospective planning of trial quality ⓘ |
| focusesOn |
general principles for clinical trials
ⓘ
quality considerations in clinical studies ⓘ |
| hasFullTitle | ICH Harmonised Guideline E8: General Considerations for Clinical Trials NERFINISHED ⓘ |
| intendedFor |
clinical investigators
ⓘ
ethics committees ⓘ pharmaceutical sponsors ⓘ regulatory authorities ⓘ |
| issuedBy | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use NERFINISHED ⓘ |
| language | English ⓘ |
| providesGuidanceOn |
analysis of clinical trial data
ⓘ
conduct of clinical trials ⓘ design of clinical trials ⓘ documentation of clinical trials ⓘ interpretation of clinical trial results ⓘ |
| relatedTo |
ICH E6 Guideline for Good Clinical Practice
NERFINISHED
ⓘ
ICH E9 Statistical Principles for Clinical Trials NERFINISHED ⓘ |
| scope | human clinical trials of medicinal products ⓘ |
| usedIn |
design of clinical trial protocols
ⓘ
regulatory review of clinical development programs ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.