Title VIII—Clinical Trial Databases

E647148

section of United States federal law

Title VIII—Clinical Trial Databases is the section of U.S. law that establishes requirements for the registration and public reporting of clinical trial information in a centralized database to improve transparency and access to trial data.

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All labels observed (3)

Label	Occurrences
Section 801 – Expanded Clinical Trial Registry Data Bank	1
Title VIII – Clinical Trial Databases	1
Title VIII—Clinical Trial Databases canonical	1

How this entity was disambiguated

This entity first appeared as the object of triple T7168869 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.

NED1 Entity disambiguation (via context triple) gpt-5-mini-2025-08-07

Target entity: Title VIII—Clinical Trial Databases
Context triple: [Food and Drug Administration Amendments Act of 2007, hasSection, Title VIII—Clinical Trial Databases]

A. ICH E8 General Considerations for Clinical Trials
ICH E8 General Considerations for Clinical Trials is an international guideline that outlines fundamental principles and quality considerations for the design, conduct, and evaluation of clinical studies across all phases of drug development.
B. ICH E2A Clinical Safety Data Management
ICH E2A Clinical Safety Data Management is an international guideline that standardizes the collection, reporting, and evaluation of clinical safety data in drug development to support consistent pharmacovigilance and regulatory decision-making.
C. Title VII Improving Access to Innovative Medical Therapies
Title VII Improving Access to Innovative Medical Therapies is a section of U.S. health reform law that expands and streamlines patient access to cutting-edge drugs, biologics, and related treatments.
D. National Center for Research Resources clinical and translational programs
The National Center for Research Resources clinical and translational programs were NIH initiatives that supported infrastructure and resources to accelerate the translation of laboratory discoveries into clinical applications and improved patient care.
E. Clinical Trials Facilitation and Coordination Group
The Clinical Trials Facilitation and Coordination Group is a working group under the Heads of Medicines Agencies that focuses on harmonizing and streamlining clinical trial assessment and regulation across European countries.
F. None of above. chosen
G. Unsure - the case is ambiguous/there is not enough information to decide.

NED2 Entity disambiguation (via description) gpt-5-mini-2025-08-07

Target entity: Title VIII—Clinical Trial Databases
Target entity description: Title VIII—Clinical Trial Databases is the section of U.S. law that establishes requirements for the registration and public reporting of clinical trial information in a centralized database to improve transparency and access to trial data.

A. ICH E8 General Considerations for Clinical Trials
ICH E8 General Considerations for Clinical Trials is an international guideline that outlines fundamental principles and quality considerations for the design, conduct, and evaluation of clinical studies across all phases of drug development.
B. ICH E2A Clinical Safety Data Management
ICH E2A Clinical Safety Data Management is an international guideline that standardizes the collection, reporting, and evaluation of clinical safety data in drug development to support consistent pharmacovigilance and regulatory decision-making.
C. Title VII Improving Access to Innovative Medical Therapies
Title VII Improving Access to Innovative Medical Therapies is a section of U.S. health reform law that expands and streamlines patient access to cutting-edge drugs, biologics, and related treatments.
D. National Center for Research Resources clinical and translational programs
The National Center for Research Resources clinical and translational programs were NIH initiatives that supported infrastructure and resources to accelerate the translation of laboratory discoveries into clinical applications and improved patient care.
E. Clinical Trials Facilitation and Coordination Group
The Clinical Trials Facilitation and Coordination Group is a working group under the Heads of Medicines Agencies that focuses on harmonizing and streamlining clinical trial assessment and regulation across European countries.
F. None of above. chosen

Statements (48)

Predicate	Object
instanceOf	section of United States federal law ⓘ
aimsTo	facilitate comparison of clinical trial results ⓘ help patients and providers identify ongoing clinical trials ⓘ support evidence-based medical decision making ⓘ
appliesTo	biologic clinical trials ⓘ clinical trials ⓘ device clinical trials ⓘ drug clinical trials ⓘ
codifiedIn	United States Code provisions related to public health and FDA regulation ⓘ
defines	responsible party for a clinical trial ⓘ
designates	Director of the National Institutes of Health as responsible official for the database ⓘ National Institutes of Health as responsible for maintaining the database ⓘ linked to: National Institutes of Health
enforcedBy	Department of Health and Human Services ⓘ linked to: United States Department of Health and Human Services Food and Drug Administration ⓘ
establishes	expanded clinical trial registry and results database ⓘ
implementedVia	ClinicalTrials.gov ⓘ
includes	provisions for civil monetary penalties for noncompliance ⓘ provisions for withholding of NIH grant funds for noncompliance ⓘ requirements for making the database searchable and user friendly ⓘ requirements for posting of key trial dates ⓘ requirements for posting of trial location information ⓘ requirements for posting of trial recruitment status ⓘ requirements for updating outdated or inaccurate information ⓘ
influenced	subsequent regulations on clinical trial registration and results reporting ⓘ
jurisdiction	United States ⓘ linked to: United States of America
partOf	Food and Drug Administration Amendments Act of 2007 ⓘ
protects	commercially confidential information in certain circumstances ⓘ personal privacy of clinical trial participants ⓘ
purpose	improve public access to clinical trial data ⓘ improve transparency of clinical trial information ⓘ reduce selective reporting of clinical trial results ⓘ
relatedTo	FDA regulation of drugs, biologics, and devices ⓘ NIH policies on clinical trial registration and reporting ⓘ clinical trial transparency policies ⓘ
requires	public availability of submitted information except for protected data elements ⓘ public posting of certain clinical trial information ⓘ registration of applicable clinical trials ⓘ submission of adverse event information for certain trials ⓘ submission of basic trial information at registration ⓘ submission of clinical trial results information ⓘ submission of enrollment information ⓘ submission of information in a standardized electronic format ⓘ submission of primary and secondary outcome measures ⓘ submission of summary results within a specified time after completion ⓘ submission of trial start and completion dates ⓘ updating of clinical trial registration records ⓘ
targets	responsible parties for clinical trials ⓘ
yearEnacted	2007 ⓘ

How these facts were elicited

Referenced by (3)

Full triples — surface form annotated when it differs from this entity's canonical label.

Food and Drug Administration Amendments Act of 2007 → hasSection → Title VIII—Clinical Trial Databases ⓘ

FDAAA → containsProvision → Title VIII – Clinical Trial Databases ⓘ

linked to: Title VIII—Clinical Trial Databases

FDAAA → containsProvision → Section 801 – Expanded Clinical Trial Registry Data Bank ⓘ