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]:
- Primary Registry and Trial Identifying Number
- Date of Registration in Primary Registry
- Secondary Identifying Numbers
- Source(s) of Monetary or Material Support
- Primary Sponsor
- Secondary Sponsor(s)
- Contact for Public Queries
- Contact for Scientific Queries
- Public Title
- Scientific Title
- Countries of Recruitment
- Health Condition(s) or Problem(s) Studied
- Intervention(s)
- Key Inclusion and Exclusion Criteria
- Study Type
- Date of First Enrollment
- Target Sample Size
- Recruitment Status
- Primary Outcome(s)
- 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: |
World Health Organization – International Clinical Trials Registry Platform: |
Search Portal: |
|
Resolution WHA 58.34 (2005): |
World Medical Association |
|
|
Declaration of Helsinki, Article 35 (2013): |
North America:
Region / Country / Agency |
Name of Registry |
Legislation |
Guidelines |
---|---|---|---|
United States |
ClinicalTrials.gov:* |
|
National Library of Medicine: FAQs on ClinicalTrials.gov:
Food and Drug Administration: Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (2004): Department of Veterans Affairs: FAQ: |
Canada |
Health Canada Clinical Trial Database: |
|
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Article 11.3: |
Europe:
Asia/Pacific/Middle East:
Region / Country / Agency |
Name of Registry |
Legislation |
Guidelines |
---|---|---|---|
Australia |
Australian New Zealand Clinical Trials Registry:* |
|
1. National Statement on Ethical Conduct in Human Research, 3.3.12 (2014): 2. FAQs: |
China |
Chinese Clinical Trial Registry:* |
|
|
India |
Clinical Trials Registry – India:* |
|
Clinical Trials Registry – India: FAQs:
Office of Drugs Controller General: Registration of Clinical Trial in ICMR Clinical Trial Registry: |
Iran |
Iranian Registry of Clinical Trials:* |
|
|
Japan |
Japan Primary Registries Network:* |
|
FAQs (Japanese): |
Korea |
Clinical Research Information Service:* |
|
|
New Zealand |
Australian New Zealand Clinical Trials Registry: |
|
|
Philippines |
Philippine Health Research Registry: |
|
FAQs: |
Sri Lanka |
Sri Lanka Clinical Trials Registry:* |
|
FAQs: |
Thailand |
Thai Clinical Trials Registry:* |
|
Latin America/Caribbean:
Region / Country / Agency |
Name of Registry |
Legislation |
Guidelines |
---|---|---|---|
Brazil |
Brazilian Clinical Trials Registry:* |
|
|
Cuba |
Public Cuban Registry of Clinical Trials:* http://registroclinico.sld.cu/en/home |
|
|
Peru |
Peruvian Registry of Clinical Trials: |
|
|
Africa:
Region / Country / Agency |
Name of Registry |
Legislation |
Guidelines |
---|---|---|---|
Pan Africa |
Pan African Clinical Trials Registry:* |
|
|
South Africa |
South African National Clinical Trials Register: http://www.sanctr.gov.za/ |
|
FAQs: |
Tanzania |
Tanzania Clinical Trial Registry: |
|
[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.