Clinical registries 

The clinical trial registries that are national, regional, or international in scope are listed below, along with relevant laws and guidance documents.

International Committee of Medical Journal Editors

Guidelines: Clinical Trial Registration:
http://icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html

 

World Health Organization – International Clinical Trials Registry Platform:
http://www.who.int/ictrp/
en/
 

Guidelines: Resolution WHA 58.34 (2005):
http://www.wpro.who.int/health_research/policy_documents/ministerial_summit_on_health_research_may2005.pdf?ua=1 - PDF

 

World Medical Association

Declaration of Helsinki, Article 35 (2013):
https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/

 

Africa 

1. Pan Africa

Pan African Clinical Trials Registry:*
https://pactr.samrc.ac.za/

FAQs:
https://pactr.samrc.ac.za/FAQ.aspx 

 

2. South Africa

South African National Clinical Trials Register: http://www.sanctr.gov.za/

FAQs:
http://www.sanctr.gov.za/InvestigatorbrnbspInformation/FAQ/tabid/200/Default.aspx

 

3. Tanzania

Tanzania Clinical Trial Registry:
http://www.tzctr.or.tz/ 

FAQs:
http://www.tzctr.or.tz/faq.php 

 

North America:

1. United States

Food and Drug Administration Modernization Act, Section 113 (1997):
http://www.gpo.gov/fdsys/pkg/PLAW-105publ115/pdf/PLAW-105publ115.pdf#page=16 - PDF

Food and Drug Administration Amendments Act, Section 801 (2007):
http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=82 - PDF

National Library of Medicine:

FAQs on ClinicalTrials.gov:
https://www.clinicaltrials.gov/ct2/manage-recs/faq 

Food and Drug Administration:

Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (2004):
https://www.fda.gov/media/71927/download

Department of Veterans Affairs:

FAQ:
http://www.research.va.gov/resources/ORD_Admin/clinical_trials/registration-faq.pdf - PDF

2. Canada

Health Canada Clinical Trial Database:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdonclin/index-eng.php

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Article 11.3:
http://www.pre.ethics.gc.ca/eng/documents/tcps2-2018-en-interactive-final.pdf - PDF

 

 

Europe:

1. European Union

EU Clinical Trials Register:*
https://www.clinicaltrialsregister.eu/

Clinical Trials Regulation No. 536/2014, Article 81:
http://ec.europa.eu/health/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf - PDF

FAQs:
https://www.clinicaltrialsregister.eu/doc/EU_CTR_FAQ.pdf - PDF

 

2. Germany

German Clinical Trials Register:*
https://www.drks.de/drks_web/

FAQs:
https://www.drks.de/drks_web/navigate.do?navigationId=faq&messageDE=FAQ&messageEN=FAQ 

3. Netherlands

Netherlands Trial Register (Dutch):*
http://www.trialregister.nl/trialreg/index.asp

 

4. Switzerland

Swiss National Clinical Trials Portal:
https://www.kofam.ch/en/snctp-portal/searching-for-a-clinical-trial/

Federal Act on Research Involving Human Beings, Articles 56, 64,65, and 67 (2011)

FAQs:
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