Source directory
Healthcare and Medical
Primary public sources for this domain, checked 2026-11-02. Delta Arc does not control these sources.
| Source | Can establish | Cannot establish | Updates |
|---|---|---|---|
| ClinicalTrials.gov fact sheet (2023 exhibit handout) | It establishes NLM's own description of who supplies registry information and that a listing does not mean federal evaluation. | It cannot establish the regulatory scope of registration or the status of any individual study. | not stated |
| ClinicalTrials.gov REST API v2 specification and study data | It establishes which fields a registry record can carry, and its query endpoints return what the registry holds at the time of a query. | It cannot establish that submitted content is accurate, that a study is sound, or that a product works. | Not stated in the specification; the API version endpoint reported a data timestamp of 2026-11-02T10:00:05 when queried. |
| 42 CFR Part 11, Clinical Trials Registration and Results Information Submission (edition dated 2025-10-01) | It establishes which trials must be registered, when results must be submitted, and the duties placed on the responsible party. | It cannot establish whether a specific study is covered or compliant without facts about that study. | not stated |
| Clinical Trials Registration and Results Information Submission, final rule and preamble, 21 September 2016 | It establishes the agency's stated explanation of what quality control review covers and what inclusion in the registry does not signify. | It cannot establish later operational changes at the registry or the handling of any particular record. | not stated |
| Food and Drug Administration Amendments Act of 2007, Public Law 110-85, Title VIII | It establishes the statutory origin of the expanded clinical trial registry data bank. | It cannot establish how the requirements were later implemented or enforced. | not stated |
| The Drug Development Process, Step 3: Clinical Research | It establishes FDA's general description of trial phases and the investigational new drug review process. | It cannot establish whether a given study was filed under an application or how FDA responded to it. | Content current as of 01/04/2018; no update schedule stated. |
| The Drug Development Process, Step 4: FDA Drug Review | It establishes FDA's general description of how a marketing application is reviewed and decided. | It cannot establish the outcome of any specific application. | not stated |
| Drugs@FDA Data Files | It establishes the downloadable structure of FDA's application, product and submission tables for products in Drugs@FDA. | Its tables are organized by application and product, so it cannot by itself connect an application record to a particular registered study. | The data file is updated each morning, Monday through Friday. |
| 510(k) Clearances | It establishes the premarket notification pathway for devices and where clearance records can be searched. | It cannot establish that a registered device study led to, or supports, a clearance. | not stated |
| FDA Adverse Event Monitoring System (AEMS) Public Dashboard, formerly FAERS | It establishes that adverse event reports were submitted to FDA and states the limits of those reports. | It cannot establish causation, incidence or the safety profile of a product. | not stated |
| About DailyMed | It establishes that DailyMed holds labeling submitted to FDA by companies and states how that differs from FDA-approved labeling. | It cannot establish that a posted label was verified by FDA or is identical to the most recent approved labeling. | not stated |
| About PubMed | It establishes that PubMed is a citation and abstract resource for biomedical literature and describes its components. | It cannot establish the full text of an article or the validity of its findings. | About page last updated March 11, 2025; no database update schedule stated on that page. |
| Requirements for Registering and Reporting NIH-Funded Clinical Trials | It establishes the NIH expectation that funded clinical trials register and submit results, alongside the federal regulation. | It cannot establish whether a particular funded trial met that expectation. | Page last updated on September 12, 2024; no update schedule stated. |
| International Clinical Trials Registry Platform (ICTRP) | It establishes WHO's definition of trial registration and points to registries outside the United States. | It cannot establish that a trial is registered through WHO, because the page states that the platform is not itself a registry. | not stated |
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How to cite this page. Delta Arc, LLC. “Source directory: Healthcare and Medical.” DA-SRC-healthcare-medical, version 1, as of 2026-11-02. https://thedeltaarc.com/sources/healthcare-medical/