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ClinicalTrials.gov

ClinicalTrials.gov is a registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. Clinical trials are registered with ClinicalTrials.gov via a web-based data entry system called the Protocol Registration System. Study registration and results reporting of “applicable clinical trials” is mandated by Public Law 110-85, also known as the Food and Drug Administration Amendments Act (FDAAA) of 2007. For a definition of “applicable clinical trials” please visit the NIH website.

 

The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition for publication.

 

NIH requires applications and progress reports to certify compliance with FDAAA in applications and progress reports.

 

Protocol Record Access

 

Clinical trial records are registered and updated using the Protocol Registration System (PRS). An individual log-in can be requested by completing the “Administrator Contact Request” form.

 

Registration and Results Reporting

  • PIs are required to register their trials no later than 21 days after enrolling the first subject and to review and verify the clinical trial records at least once every 6 months, but no less frequently than every 12 months. Additional requirements exist and may require more frequent reporting if, for example, there are recruitment changes, adverse events and/or if a trial enrolls its final participant. Study results must be posted no later than 12 months from the completion date. This date is called the “Primary Completion Date” and is entered at the time of the initial registration.
  • Please note:There are stringent rules governing clinicaltrials.gov registration and results reporting that may involve fines for non-compliance.

 

Contact Information

 

If you have general questions about registering and updating a trial, please contact the SIBCR administrator, This email address is being protected from spambots. You need JavaScript enabled to view it..

 

If you are not sure whether or not you need to register results, email PRS directly at This email address is being protected from spambots. You need JavaScript enabled to view it.">This email address is being protected from spambots. You need JavaScript enabled to view it..

 

Helpful Links

 

http://www.washington.edu/research/hsd/docs/753

http://grants.nih.gov/ClinicalTrials_fdaaa/

http://clinicaltrials.gov/

http://prsinfo.clinicaltrials.gov/registering.pdf

http://prsinfo.clinicaltrials.gov/

 

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