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- Home | ClinicalTrials. gov
ClinicalTrials gov is a website and online database of clinical research studies and information about their results The National Library of Medicine (NLM) maintains the website
- ClinicalTrials. gov: Requirements and Implementation Strategies
The Food and Drug Administration Amendments Act of 2007 (FDAAA) established a requirement for certain clinical trials to be registered at trial initiation and to report summary results after trial completion in the public registry and results database called ClinicalTrials gov
- Clinical study protocol template - ClinicalTrials. gov
Prominent T cell involvement occurs in the pathogenesis of PsA (Tassiulas et al 1999; Curran et al 2004; Mease and Armstrong 2014) and clinical trials have shown efficacy of T cell-targeted treatment that has included cyclosporine A, CTLA4-Ig, and alefacept
- Changes from Current Practice Described in the Final Rule
In general, clinical trial information submitted to ClinicalTrials gov must be updated not less than once every 12 months The Final Rule further requires that some data elements be updated more rapidly, as summarized in Table 3 below
- ClinicalTrials. gov PRS: Login
See How to Apply on ClinicalTrials gov for information on how to apply for a PRS account See PRS Guided Tutorials for assistance with entering registration and results information in the PRS
- Clinical Trials Checklists
ClinicalTrials gov A service of the National Institutes of Health *Required *§ Required if Primary Completion Date is on or after January 18, 2017 [*] Conditionally required Participant Flow Checklist
- Statistical Analysis Plan template - ClinicalTrials. gov
A protocol deviation is any noncompliance with the clinical trial protocol or International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) requirements
- Checklist June Version (v5) - ClinicalTrials. gov
The final rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) specifies requirements for submitting clinical trial information to ClinicalTrials gov
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