Title VIII—Clinical Trial Databases
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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 |
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf | section of United States federal law ⓘ |
| aimsTo |
facilitate comparison of clinical trial results
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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of trial location information ⓘ requirements for posting of trial recruitment status ⓘ requirements for updating outdated or inaccurate information ⓘ |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 ⓘ |
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
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hasSection
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Title VIII—Clinical Trial Databases
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