ClinicalTrials.gov

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Summary

ClinicalTrials.gov is a website and online database of clinical research studies and information about their results. The purpose of ClinicalTrials.gov is to provide information about clinical research studies to the public, researchers, and health care professionals. ClinicalTrials.gov relies on sponsors or investigators to submit and update information about studies. It lists up-to-date information on clinical research studies and their results, with new studies added almost every day. The database includes studies that take place in all 50 states and over 200 countries. It also supports laws, regulations, and policies that require sponsors and investigators to publicly share information about clinical trials, including results.

Agency HHS, NIH, NLM
Data Checkup

Historical Data Availability

No Known Issue

Future Data Availability

No Known Issue

Data Quality

No Known Issue

Statutory Context

No Known Issue
Section 113 of the Food and Drug Administration Modernization Act of 1997 (FDAMA; Pub. L. 105-115) required the National Institutes of Health (NIH) to establish and maintain a publicly accessible registry of clinical trials and to make clinical trial information available to patients, healthcare providers, researchers, and the public.

Staffing and Funding

Moderate Risk
From FY2024 to FY2026, NIH has lost more than 4,000 staff (~20% of workforce).

Policy

High Risk
Per February 2026 ICR, data collection on sex posted on ClinicalTrials.gov complies with both Executive Order 14168 and 42 CFR Part 11. Consistent with the preamble section of 42 CFR Part 11, ClinicalTrials.gov adopted a standardized “Sex” data element with three options: “male”, “female”, and “all” (indicating that the recruitment criteria do not limit eligibility based on sex). In alignment with Executive Order 14168, federal forms will not request gender identity and federal funds should not be used to promote gender ideology. In line with these directives, the gender-related data elements are not mandatory for all studies and do not impose requirements on study design or data collection.
Last updated: 2026-07-17

Details

OMB Control Number 0925-0586
Authorizing Statutes 42 USC 282(i), 42 USC 282(j), Pub.L. 110 - 85 801, Pub.L. 105 - 115 113
Related ICRs
Reference Number Title Agency Status Request Type
202512-0925-004 Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM) HHS/NIH Active
Revision of a currently approved collection
202302-0925-001 Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM) HHS/NIH Historical Active
Extension without change of a currently approved collection
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