Study Set Content:
is concerned with the design, conduct, safety and reporting of clinical trials It also covers novel types
of medicines derived from biotechnological processes and the use of Pharmacogenetics genomics
techniques to produce better targeted medicines
The work carried out by ICH under the
Efficacy heading
E1-E2F
CLINICAL SAFETY
E3
CLINICAL STUDY REPORTS
E4
DOSE-RESPONSE STUDIES
E5
ETHNIC FACTORS
E6
GOOD CLINICAL PRACTICE
E7-E11
CLINICAL TRIALS
E12
CLINICAL EVALUATION BY THERAPEUTIC CATEGORY
E14
CLINICAL EVALUATION
E15-E16
PHARMACOGENOMICS
Those are the cross-cutting topics which
don’t fit uniquely into one of the Quality,
Safety and Efficacy categories
Multidisciplinary Guidelines
Multidisciplinary guidelines includes
ICH medical terminology,
Common Technical Document (CTD),
Development of Electronic, Standards
for the Transfer of Regulatory
Information (ESTRI)
M1
MEDRA TERMINOLOGY
M2
ELECTRONIC STANDARDS
M3
NON-CLINICAL SAFTY STUDIES
M4
COMMON TECHNICAL DOCUMENT
M5
DATA ELEMENTS AND STANDARDS FOR DRUG DICTIONARIES
M6
GENE THERAPY
M7
GENOMIC IMPURITIES
M8
ELECTRONIC COMMON TECHNICAL DOCUMENT (ECTD)
