The International Council for Harmonisation (ICH): 'E' group of guidelines
Below is the overview of 'E' group of ICH guidelines that collectively apply to different stages and types of pre- / clinical research and development.
ICH: ‘E’ group of guidelines overview
| |
General Considerations for Clinical Studies: | |
Design and Analysis: | E4 Dose-Response Studies |
E9 Statistical principles for Clinical Trials | |
E10 Choice of Control Group in Clinical Trials | |
E17 Multi-Regional Clinical Trials | |
Conduct and Reporting: | E3 Clinical Study Reports |
| |
Safety Reporting: | E1 Clinical Safety for Drugs used in Long-Term Treatment |
E2A – E2F Pharmacovigilance | |
E14 Clinical Evaluation of QT | |
E19 Safety Data Collection | |
Populations: | E5 Ethnic Factors |
E7 Clinical Trials in Geriatric Population | |
E11 – E11A Clinical Trials in Pediatric Polulations | |
E12 Clinical Evaluation by Therapeutic Category | |
Genetics / Genomics | E15 Definitions in Pharmacogenetics/Pharmacogenomics |
E16 Qualification of Genomic Biomarkers | |
E18 Genomic Sampling |
Other EU Guidelines:
Author: European Medicines Agency
Clinical Research News
Upcoming Clinical Research Training and Conferences
-
on demandACROSS Global Training AcademyOnline
-
29 September 2023 – 02 October 2024SCDM (Society of Clinical Data Management)United States
-
21 – 23 May 2024InformaBelgium
-
03 – 04 June 2024The Society for Clinical Research Sites (SCRS)United States
-
16 – 17 July 2024The Society for Clinical Research Sites (SCRS)Australia
-
27 September – 29 October 2024The Society for Clinical Research Sites (SCRS)United States
Připravované klinické studie
-
University of Western SydneyUniversity of Auckland, New ZealandNábor
-
University of Southern CaliforniaUniversity of California, IrvineZatím nenabírámeAlzheimerova nemoc | Kognitivní úpadek související s věkem
-
Karaman Training and Research HospitalZatím nenabírámeObezita, morbidníKrocan
-
Istanbul Medipol University HospitalZatím nenabírámeZdraví dospělí | Inspirativní svalový tréninkKrocan
-
Muhammad IlyasZatím nenabírámeNevolnost a zvracení, pooperační
-
University of LeicesterUniversity Hospitals, LeicesterZatím nenabírámeIntracerebrální krvácení
-
University of SienaNáborParadentóza | Zánět dásní | Chlorhexidin | Cetylpyridinium chloridItálie
-
Istanbul Medipol University HospitalNáborAtletická zraněníKrocan
-
McMaster UniversityZatím nenabíráme
-
Örebro University, SwedenRegion Örebro CountyNáborChronická bolest | Emocionální úzkostŠvédsko
-
NICHD Pelvic Floor Disorders NetworkEunice Kennedy Shriver National Institute of Child Health and Human Development... a další spolupracovníciZatím nenabírámeÚnik moči | Komplikace doručeníSpojené státy