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Human Subjects Division (HSD)

Announcements

NIH-funded Clinical Trials

Feb 9, 2010 at 3:42pm

Requirement to register clinical trials.  For the past few years, there has been a federal requirement to register clinical trials, usually with a federal site called ClinicalTrials.gov.   The purpose of the registration requirement is to increase transparency and knowledge about clinical trials and their results.

The University's institutional liaison and contact point with ClinicalTrials.gov is Arna Elezovic.  She is the clinical trials administrator at the Human Subjects Division.   elezovic@u.washington.edu  206-543-0639

Recent change in NIH policy.   The National Institutes of Health (NIH) have usually registered the trials that it funds.  However, NIH recently decided that it will no longer perform this service for researchers.  Instead, researchers are now responsible for the registration process.  In addition, NIH has started to ask researchers with ongoing NIH-funded clinical trials to transfer the registration "ownership" from NIH to the researchers themselves.

Transferring registration "ownership" from NIH to yourself.  Here are the simple instructions for how to transfer registration ownership of your clinical trial from NIH to yourself. 

1.       Contact your grant's NIH program officer to obtain the following information for your clinical trial:

  • The username used by your NIH program to login to the ClinicalTrials.Gov system when NIH registered your trial
  • The organization name used by your NIH program to register your trial
  • The NCT trial number for your trial

2.       Gather the following additional information:

Your NIH grant number (activity code, institute code, and 6 digit serial number)

Example:  R01AG013131

3.       Contact Arna Elezovic at the Human Subjects Division.

She is the UW institutional contact and liaison with the ClinicalTrials.gov system.

elezovic@u.washington.edu / 206-543-0639

4.       Set up an investigator (personal) account with the ClinicalTrials.gov system called PRS (Protocol Registration System), following the instructions provided by Arna.   If you already have an investigator account, Arna will provide alternate instructions.

The website for the ClinicalTrials.gov system is called PRS, where investigators create accounts and register/transfer trials:  http://prsinfo.clinicaltrials.gov