Registration

Important Note: Study Start (Initiation) Date is the date on which the first participant is enrolled. "Enrolled" means a participant's, or their legally authorized representative’s, agreement to participate in a clinical study following completion of the informed consent process. Potential participants who are screened for the purpose of determining eligibility for the study, but do not participate in the study, are not considered enrolled, unless otherwise specified by the protocol.

Tip Sheet for Completing Study Registrations

What studies need to be registered?

  • Studies funded by NIH
    • NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information, which encompasses a broader definition of clinical trials than required by the FDA.
    • Applies to applications for funding, including for grants, other transactions and contracts, submitted on or after January 18, 2017, that request support for the conduct of a clinical trial that is initiated on or after January 18, 2017.
       
  • Applicable Clinical Trials (ACTs) as defined by the FDA
    • Study initiation prior to January 18, 2017
      • Follow the Food and Drug Administration Amendments Act, Section 801 (FDAAA 801) requirements
    • Study initiation on or after January 18, 2017
      • Follow the regulations implementing FDAAA 801
      • You may find this checklist to be helpful.
      • Important Note: Exercise caution in determining whether the study evaluates at least one drug, biological, or device product regulated by the U.S. FDA. This is not the same as determining whether the study is conducted under an IND application or IDE. Refer to the "Oversight" guidance in the Tip Sheet.
         
  • There is intent to publish the study in a journal that follows the International Committee of Medical Journal Editors (ICMJE) clinical trial registration policy.
     
  • Registration is required by the Center for Medicare and Medicaid Services (CMS) Change Request 8401.
     
  • Studies for which there are otherwise funding agency or sponsor requirements (review the grant and/or contract for your study).

What studies should be registered under the University of Pittsburgh PRS account?

If the University of Pittsburgh is the Sponsor Organization (the primary organization conducting the study and associated data analysis), the study must be registered under the UPittsburgh PRS account.

Who is the Responsible Party for a study under University of Pittsburgh?

Determination of Responsible Party for a UPittsburgh record depends on whether the study is subject to FDA regulation.

Not FDA regulated: The Principal Investigator is always the Responsible Party and should be selected from the dropdown box, and leave Sponsor as the default University of Pittsburgh.

 FDA regulated study:

  • Sponsor: the individual who holds the IND or IDE (if applicable) and initiates a clinical investigation.
  • Investigator: the individual who conducts a clinical investigation (PI).
  • Sponsor-Investigator: Both, as defined above.
    • The Sponsor-Investigator is always the Responsible Party and should be selected from the dropdown box.
    • Note: If the Sponsor and the Investigator are different individuals, please contact ctgov@pitt.edu for guidance.

How do I register a study under University of Pittsburgh?

The Responsible Party and Record Owner will need UPittsburgh PRS user accounts to register the study. If the user accounts do not already exist, or you are unsure, please send full names, preferred business e-mail addresses and telephone numbers to ctgov@pitt.edu

What is the deadline for registering a study?

FDA ACTs and studies subject to the NIH Policy must be submitted no later than 21 calendar days following the date of the first enrollment.

Studies that may be subject to the ICMJE policy must be registered (NCT number assigned) prior to informed consent of the first subject.