International & Local Recommendations, Standards, Guidelines, Regulations, Documents & Useful Links in relation to Clinical Trials Registration

Recommendations, Standards, Guidelines & Regulations
International & Local
Handbook on Clinical Research Management and Compliance at Study Sites
ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals
The CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
WHO Handbook for Good Clinical Research Practice (GCP)
WHO International Standards for Clinical Trial Registries
WHO Statement on Public Disclosure of Clinical Trial Results
WMA 2013 Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
United States
Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Food and Drug Administration Modernization Act of 1997 (FDAMA)
NLM Technical Bulletin: to Include Basic Results Data
Policy Ensuring Public Availability of Results from NCI-supported Clinical Trials
Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801)
European Union
Article 11 of the Directive 2001/20/EC
Article 41 of the Paediatric Regulation (EC) No 1901/2006
Article 57 of the Regulation (EC) No 726/2004
EMA Press Release October 11, 2013: European Medicines Agency launches a new version of EudraCT: Summary results of clinical trials soon to be available to the public
Forms for HKUCTR
HKU Clinical Trials Registry Online Study Registration Form
HKU Clinical Trials Registry Study Data Public Disclosure Form
Useful Links
Clinical Trials Centre, The University of Hong Kong
Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster
International Committee of Medical Journal Editors
WHO International Clinical Trials Registry Platform