ClinicalTrials.gov Resources
ClinicalTrials.gov allows patients, their family members, healthcare professionals, researchers, and the public access to information on clinical studies.
Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the research study.
When conducting an Applicable Clinical Trial (ACT) per U.S federal regulations (42 CFR Part 11)
This includes:
- Controlled clinical trials of FDA-regulated drugs or biologics (Phases II - IV); and
- Controlled clinical trials and pediatric post-market surveillance of FDA-regulated devices (other than small feasibility studies).
- See the ClinicalTrials.gov "Applicable Clinical Trial (ACT)" checklist (https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf )to determine if registration of a study is required per federal regulations.
When conducting a clinical trial funded by the National Institutes of Health (NIH) per NIH policy
If the answer is “yes” to all four of the following questions, then the research study would be considered a clinical trial according to the NIH definition:
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect being evaluated a health-related biomedical or behavioral outcome?
See NIH Definition of Clinical Trial Case Studies for additional guidance
in determining if a research study is an NIH defined clinical trial.
For publication in a journal that follows the International Committee of Medical Journal Editors' (ICMJE) policy
which requires registration of clinical trials in a public trials registry as a condition of consideration for publication.
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Resources |
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Account, Protocol Registration and Record Maintenance |
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Result Reporting |
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National Institutes of Health (NIH) |
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International Committee of Medical Journal Editors (ICMJE) |
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ICF Language, ICF Upload – Common Rule |
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Education and Training |
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Links and Supplementary Resources |
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PI Off Boarding |
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Civil Money Penalties |
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University of Utah Clinical Trials.Gov Contacts |