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:

E 8 (R1) ICH Consensus Guideline

 

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:

Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

 

 

Author: European Medicines Agency

Clinical Research News

Applying for a Paediatric investigation plan (PIP): review of the EMA guidelines
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products
Submission of comments on ICH E6 (R3) Guideline for Good Clinical Practice(GCP) - Step 2b 
ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation
The study of the new investigational drug for acute myeloid leukemia and myelodysplastic syndrome
Open Label study of entrectinib in ROS1 gene fusion-positive rare adult, paediatric and teenage/young adult cancers
Gasherbrum Bio, Inc is starting the study of GSBR-1290 drug in overweight or obese healthy adults

Upcoming Clinical Research Training and Conferences

All events

Kommende kliniske forsøg

Clinical Research Jobs

All jobs

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner