Listing of Clinical Trial Registries

May 28, 2015

The International Committee of Medical Journal Editors announced a policy in 2004 that as a condition of publication, clinical trials would be required to be listed in a public registry [1]. Subsequently, regulatory authorities around the world began to require the posting of clinical trial information and, in some cases, the submission of summary results to a publicly accessible registry. Likewise, some research funding agencies are now encouraging or requiring the registration and results reporting of the clinical trials they fund.

The World Health Organization Trial Registration Data Set directs that the following 20 elements be included in a clinical trial registry [2]:

  1. Primary Registry and Trial Identifying Number
  2. Date of Registration in Primary Registry
  3. Secondary Identifying Numbers
  4. Source(s) of Monetary or Material Support
  5. Primary Sponsor
  6. Secondary Sponsor(s)
  7. Contact for Public Queries
  8. Contact for Scientific Queries
  9. Public Title
  10. Scientific Title
  11. Countries of Recruitment
  12. Health Condition(s) or Problem(s) Studied
  13. Intervention(s)
  14. Key Inclusion and Exclusion Criteria
  15. Study Type
  16. Date of First Enrollment
  17. Target Sample Size
  18. Recruitment Status
  19. Primary Outcome(s)
  20. Key Secondary Outcomes

The 24 clinical trial registries that are national, regional, or international in scope are listed below, along with relevant laws and guidance documents [3]. Some, such as the WHO Search Portal and the Canadian Clinical Trial Database, are not technically classified as a “registry,” but are included in this Listing for the purpose of comprehensiveness. Registries that are recognized by the International Committee of Medical Journal Editors[4] are indicated with an asterisk: *

International:

Region / Country / Agency

Name of Registry

Legislation

Guidelines

International Committee of Medical Journal Editors

 

 

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/

Search Portal:
http://apps.who.int/trialsearch/

 

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

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/

 

North America:

Region / Country / Agency

Name of Registry

Legislation

Guidelines

United States

ClinicalTrials.gov:*
https://www.clinicaltrials.gov/ct2/home

  1. Food and Drug Administration Modernization Act, Section 113 (1997):
    http://www.gpo.gov/fdsys/pkg/PLAW-105publ115/pdf/PLAW-105publ115.pdf#page=16
  2. Food and Drug Administration Amendments Act, Section 801 (2007):
    http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=82

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

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

 

Europe:

Region / Country / Agency

Name of Registry

Legislation

Guidelines

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

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

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

Netherlands

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

 

 

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:
http://www.kofam.ch/en/swiss-clinical-trials-portal/search-help-and-explanations.html

United Kingdom

ISRCTN:*

http://www.isrctn.com/

 

ISRCTN:

FAQs:
http://www.isrctn.com/page/faqs

 

Health Research Authority:

Transparency, Registration, and Publication:
http://www.hra.nhs.uk/resources/during-and-after-your-study/transparency-registration-and-publication/

 

Asia/Pacific/Middle East:

Region / Country / Agency

Name of Registry

Legislation

Guidelines

Australia

Australian New Zealand Clinical Trials Registry:*
http://www.anzctr.org.au/

 

1. National Statement on Ethical Conduct in Human Research, 3.3.12 (2014):
http://www.nhmrc.gov.au/guidelines-publications/e72

2. FAQs:

http://www.anzctr.org.au
/Faq.aspx

China

Chinese Clinical Trial Registry:*
http://www.chictr.org.cn/enIndex.aspx

 

FAQs:
http://www.chictr.org.cn/questionen.aspx

India

Clinical Trials Registry – India:*
http://ctri.nic.in/

 

Clinical Trials Registry – India:

FAQs:
http://ctri.nic.in/Clinicaltrials/faq.php

 

Office of Drugs Controller General:

Registration of Clinical Trial in ICMR Clinical Trial Registry:
http://www.cdsco.nic.in/writereaddata/CTRegistration.doc

Iran

Iranian Registry of Clinical Trials:*
http://www.irct.ir/

 

FAQs:
http://www.irct.ir/page/help

Japan

Japan Primary Registries Network:*
https://rctportal.niph.go.jp/

 

FAQs (Japanese):
https://rctportal.niph.go.jp/how

Korea

Clinical Research Information Service:*
https://cris.nih.go.kr/cris/en/use_guide/cris_introduce.jsp

 

 

New Zealand

Australian New Zealand Clinical Trials Registry:
http://www.anzctr.org.au/

 

FAQs:
http://www.anzctr.org.au/Faq.aspx

Philippines

Philippine Health Research Registry:
http://registry.healthresearch.ph/

 

FAQs:
http://registry.healthresearch.ph/index.php/component/healthregistry/?view=reports

Sri Lanka

Sri Lanka Clinical Trials Registry:*
https://slctr.lk/

 

FAQs:
http://slctr.lk/faq

Thailand

Thai Clinical Trials Registry:*
http://www.clinicaltrials.in.th/

 

FAQs:
http://www.clinicaltrials.in.th/index.php?meun=home&smenu=4&task=home&task1=openpage&task2=view&topid=4

 

Latin America/Caribbean:

Region / Country / Agency

Name of Registry

Legislation

Guidelines

Brazil

Brazilian Clinical Trials Registry:*
http://www.ensaiosclinicos.gov.br/

 

FAQs:
http://www.ensaiosclinicos.gov.br/assistance/faq/

Cuba

Public Cuban Registry of Clinical Trials:* http://registroclinico.sld.cu/en/home

 

 

Peru

Peruvian Registry of Clinical Trials:
https://www.ins.gob.pe/ensayosclinicos/

 

 

 

Africa:

Region / Country / Agency

Name of Registry

Legislation

Guidelines

Pan Africa

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

 

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

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

Tanzania

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

 

FAQs:
http://www.tzctr.or.tz/faq.php


[1] http://www.icmje.org/news-and-editorials/clin_trial_sep2004.pdf

[2] http://www.who.int/iris/bitstream/10665/76705/1/9789241504294_eng.pdf?ua=1

[3] In addition, numerous disease-specific, device-specific, procedure-specific, and other registries are known to be in existence.

[4] http://www.icmje.org/

Content created by Office for Human Research Protections (OHRP)
Content last reviewed on June 10, 2015