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.
Who determines whether a study will be registered?
You should coordinate with any applicable collaborators, but note that the initiator/sponsor (responsible for overall study preparation, planning and control; when applicable, the FDA IND/IDE holder) is ultimately responsible for this determination. ClinicalTrials.gov allows the registration of clinical studies with human subjects that assess biomedical and/or health outcomes. Requirements for study registration are listed below. Registering otherwise is considered optional, but maintaining the record is mandatory in all cases.
What studies need to be registered?
NIH-Funded Clinical Trials
The NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information applies to a broader definition of clinical trials (i.e., not limited to drug and device interventions). The Policy 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.
FDA-regulated Applicable Clinical Trials
The Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801) (studies initiated prior to January 18, 2017) and the regulations implementing FDAAA 801 (studies initiated on or after January 18, 2017) require registration of Applicable Clinical Trials (ACTs) initiated after September 27, 2007, and those initiated previously and ongoing as of December 26, 2007. Consult the ACT Checklist, including the Elaboration following the Checklist.
- 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 (link above).
- Device studies of at least 10 subjects that evaluate health outcomes (i.e., preliminary safety and effectiveness) in addition to feasibility are generally not considered Device Feasibility studies in the context of ACT determination.
Note: This excludes expanded access programs, but see guidance under “Study Type” in the Tip Sheet (link above) regarding when an expanded access record is required. This includes all FDA-ordered pediatric postmarket device surveillance, even if not a clinical trial. Contact CTgov@pitt.edu for help.
Intent to Publish
The International Committee of Medical Journal Editors (ICMJE) Clinical Trial Registration Policy applies to a broader definition of clinical trials (i.e., not limited to drug and device interventions). Generally, the study should be registered if it meets the ICMJE definition of clinical trial and there is intent to publish the study results in a journal.
- There are special considerations when studying an FDA-regulated device product that is not yet approved or cleared. Refer to the "Oversight" guidance in the Tip Sheet (link above).
- Some journals may have their own study registration policies that are broader in scope (e.g., including observational studies). Inquire with your journals of interest before initiating your study.
Billing Items or Services to Health Insurance
Other Funder or Collaborator Requirement
Review applicable grants and/or contracts for other funding agency or collaborator requirements.
What is the deadline for registering a study?
Studies that may be subject to the ICMJE policy must be registered (verify NCT number assigned and posted on public site) prior to informed consent of the first subject.
Clinical trials not subject to ICMJE but required to be registered per FDAAA 801 or NIH Policy, must be submitted to ClinicalTrials.gov no later than 21 calendar days following the Study Start Date (as defined above).
What studies should be registered under the University of Pittsburgh PRS account?
Each study must be registered in the ClinicalTrials.gov PRS account of the Sponsor Organization, which is the primary organizational affiliation of the initiator (responsible for overall preparation, planning and control) of the study. When applicable, the FDA IND or IDE holder is considered the initiator. If the University of Pittsburgh or UPMC is the Sponsor Organization of the study, then the study must be registered in the University of Pittsburgh (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: Specify the Principal Investigator as Responsible Party and leave "Sponsor" as the default University of Pittsburgh.
- FDA-regulated study: Specify the Sponsor-Investigator as Responsible Party. If the Sponsor and Investigator are different individuals, contact CTgov@pitt.edu for help.
- 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).
Note: Full contact information (name, official title, organizational affiliation, physical address, mailing address, phone number, and email address) is required for Responsible Parties of studies subject to FDAAA and the NIH Policy. This is entered as part of the Responsible Party’s PRS user account information by clicking “Update” next to the e-mail address in the upper right-hand corner of the homepage.
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. Please send full names, preferred business e-mail addresses, and the PittPRO STUDY number (if applicable) to CTgov@pitt.edu.