Office of Research and Project Administration

The National Institutes of Health (NIH) has posted a Frequently Asked Questions (FAQ) concerning the posting of information in ClinicalTrials.gov.  Links to the NIH Guide notice concerning the FAQ and the FAQs are included below.   NIH will continue to update the FAQs as appropriate.

The pertinent information regarding when trials should be registered is reproduced below.
 
More information concerning registering, definitions of serious and life threatening, responsible party, etc., are available at the FAQs.

NIH Guide Notice: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html

FAQs: http://grants.nih.gov/grants/policy/hs/faqs_aps_clinical_trials.htm

 
When must the trials be registered?

o                          Trials initiated after 9/27/2007, or trials initiated before that date and ongoing on 12/26/2007 that involve a “serious or life threatening disease or condition,” must be registered in full by:  the later of 12/26/2007 or 21 days after the first patient is enrolled.

o                          Trials that were initiated before 9/27/07 that are “ongoing” as of 12/26/2007, and which do not involve a “serious or life threatening disease or condition,” must be registered by 9/27/2008.  

o                          Trials that were initiated before 9/27/07 and are “ongoing” as of 12/26/2007, which do involve a “serious or life threatening disease or condition,” and are completed (meaning, not “ongoing”) by 12/26/2007 are not subject to these requirements, though they may be subject to pre-existing registering requirements.

(“Ongoing” in this context means a trial had one or more patients enrolled, but had not reached its “completion date,” meaning, examined the final subject or provided the final subject an intervention for the purposes of final collection of data for the primary outcome as of 9/27/2007.)  

Please contact your ORPA RA or Eric Rubinstein with any questions.

Eric Rubinstein – x6-4284 (Director, Office of Regulatory Support, Clinical & Translational Science Institute)

Anthony Beckman - x5-1502

Donna Beyea - x5-8037

Marlene Boutet - x3-3960

Brenda Kavanaugh - x5-1504

Jane Tolbert - x5-4210

Cheryl Williams - x5-1503

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Jane Tolbert
Research Administrator
Office of Research & Project Administration
University of Rochester
503 Hylan Building
RC Box 270140
Rochester, NY 14627
Phone: 585-275-4210
Fax: 585-275-9492
Email: jtolbert@orpa.rochester.edu