Mandatory Clinical Trial Registration

You are individually responsible for complying with the registration requirements if you are the “Responsible Party” of an Applicable Clinical Trial.

Please review the detailed information at ClincalTrials.gov (http://prsinfo.clinicaltrials.gov/s801-fact-sheet.pdf) and NIH.gov (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014) to determine if action is required by you to comply with these federal regulations.

If you are the “Responsible Party” and have not registered an Applicable Clinical Trial in ClinicalTrials.gov, please contact the OUHSC “PRS Administrators”, Jason Jobson (jason-jobson@ouhsc.edu) or Janice Gales (janice-gales@ouhsc.edu) in the Office of Human Research Participant Protection, for registration assistance. HRPP phone number: 405-271-2045

Summary of the Federal Requirements

What Clinical Trials must be registered at ClinicalTrials.gov? (“Applicable Clinical Trials”)

1. Trials of Drugs and Biologics: Controlled clinical investigations of a product subject to FDA regulation, other than Phase I investigations
   
   
2. Trials of Devices: Controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies and pediatric postmarket surveillance
   

Who is responsible for trial registration? (“Responsible Party”)

1. The sponsor of the clinical trial (per 21 CFR 50.3) – OR -
   
   
2. The principal investigator of the clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the PI is responsible for conducting the trial and has sufficient data rights.

When must the Responsible Party register?

1. Trials initiated after 9/27/2007 and trials that are “ongoing” as of 12/26/2007 must be registered in full by the later of 12/26/2007 or 21 days after the first patient is enrolled.
   
   
2. Trials that were “ongoing” as of 9/27/2007 and do not involve a “serious or life threatening disease or condition”, must be registered by 9/27/2008.
   
   
3. Trials that were “ongoing” as of 9/27/2007, do involve a “serious or life threatening disease or condition”, and are completed by 12/26/2007 are not subject to the new requirements under Public Law 110-85 (see below), although they may be subject to preexisting registration requirements.

Penalties for Responsible Parties who fail to register, or provide false or misleading information in connection with, Applicable Clinical Trials are significant and may include civil monetary penalties and, for federally-funded trials the withholding or recovery of grant funds.

Public Law 110-85:
http://frwebgate.access.gpo.gov/cgibin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf