Title VIII—Clinical Trial Databases
E647148
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.
All labels observed (1)
| Label | Occurrences |
|---|---|
| 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]
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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.
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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.
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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.
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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.
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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 NERFINISHED ⓘ |
| enforcedBy |
Department of Health and Human Services
NERFINISHED
ⓘ
Food and Drug Administration NERFINISHED ⓘ |
| establishes | expanded clinical trial registry and results database ⓘ |
| implementedVia | ClinicalTrials.gov NERFINISHED ⓘ |
| 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 of America
ⓘ
surface form:
United States
|
| partOf | Food and Drug Administration Amendments Act of 2007 NERFINISHED ⓘ |
| 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
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: Title VIII—Clinical Trial Databases Description of subject: 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.
Referenced by (1)
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
ⓘ