Clinical Trial Guidelines

Guidelines on Clinical Trials

A

A Standard for the Scientific and Ethical Review of Trials (ASSERT)
Australian Therapeutic Goods Administration
Association of Clinical Research Professionals

C

CancerIndex
Cancernet.co.uk
Central Committee on Research Involving Human Subjects (CCMO)
Clinical Trials Tool Kit
The Cochrane Collaboration
Community of Science
The CONSORT Statement

E

European Agency for the Evaluation of Medicinal Products (EMEA)
European Clinical Trials Directive 2001/20/EC

H

Heads of EU Agencies Website

I

International Committee of Medical Journal Editors (ICMJE) - Uniform Requirements for Manuscripts Submitted to Biomedical Journals
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - Guideline for Good Clinical Practice (ICH GCP)
International Directory of Government and Regulatory Bodies (Pharmweb)

J

James Lind Library

M

Medical Dictionary for Regulatory Activities Terminology (MedDRA)

P

PhRMA New Medicines in Development Database

Q

The Quality Of Reporting Of Meta-analyses (QUOROM) Statement

U

The UK Medicines and Healthcare products Regulatory Agency (MHRA)
UK Central Office for Research Ethics Committees (COREC)
UK Department of Health Policy and Guidance on Research and Development
UK National Library for Health

US Food and Drug Administration (FDA)
US National Institutes of Health (NIH): Institutes, Centers & Offices
US Office for Human Research Protections (OHRP)

W

WHO Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products
WHO International Clinical Trials Registry Platform (ICTRP)
WHO operational guidelines for ethics committees that review biomedical research
World Medical Association Declaration of Helsinki