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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 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
- ClinicalTrials. gov PRS: Home page (Beta)
The National Library of Medicine (NLM) has launched an effort to modernize ClinicalTrials gov We will be continually delivering improvements throughout the modernization effort
- 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 Trials Checklists
Baseline Characteristics Data Preparation Checklist Overview: The Baseline Characteristics module is a tabular summary of data for each demographic and base-line measure by arm or comparison group and for the entire population of participants in the clinical study Use this checklist with the Results Data Element Definitions and the Simple Results Templates for Age, Sex Gen-der, Race
- 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
- 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
- Checklist June Version (v5) - ClinicalTrials. gov
The “Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT)” (or “ACT Checklist”) and this elaboration is intended to assist users in evaluating whether a clinical trial or study is considered to meet the definition of an ACT, as specified in 42 CFR 11 22(b), and is subject to “expanded
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