SOP: Registration
Registration Information Tip Sheet
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.
What studies need to be registered?
ClinicalTrials.gov allows registration of clinical studies with human subjects that assess biomedical and/or health outcomes. Requirements for study registration are listed below. Each of the listed requirements should be independently reviewed for applicability to the study. Inapplicability of one requirement does not imply that none of the others will apply. Registering otherwise is considered optional, but maintaining the record is mandatory in all cases.
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) of drugs and medical devices initiated after September 27, 2007, and those initiated previously and ongoing as of December 26, 2007.
- 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).
- Studies that evaluate health outcomes (i.e., preliminary safety and effectiveness) in addition to device feasibility or include at least 10 subjects 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.
NIH-Funded Clinical Trials
The NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information requires registration of any NIH-funded clinical trial (not limited to drug and device interventions) initiated on or after January 18, 2017, for which support for conduct of the trial is requested in an application for funding (including for grants, other transactions and contracts) submitted on or after January 18, 2017. Refer to the PHS Human Subjects and Clinical Trials Information Form in the grant application and the specific Notice of Award for more information.
Important points on NIH-defined Basic Experimental Studies with Humans (BESH):
NIH considers BESH proposed in funding applications with due dates on or before May 24, 2026 to be clinical trials subject to the Policy. Refer to the Basic Experimental Study Involving Humans (BESH) Legacy Information.
- There is flexibility for BESH submitted to funding opportunities designated as “basic experimental studies with humans” in the title (NOT “clinical trial required” or “clinical trial optional” funding opportunities) to register and report results on alternative publicly available platforms, if so described in the funding application. However, the study may still need to be registered on ClinicalTrials.gov per ICMJE Policy (see below).
NIH does NOT consider BESH proposed in funding applications with due dates on or after May 25, 2026 to be clinical trials subject to the Policy. Refer to Is My Project a Clinical Trial, Basic Experimental Study Involving Humans (BESH), or an Observational Study Involving Humans?
- However, the study may still need to be registered on ClinicalTrials.gov per ICMJE Policy (see below).
View the presentation on NIH Changes for BESH for more information.
Intent to Publish
The International Committee of Medical Journal Editors (ICMJE) Clinical Trial Registration Policy requires registration of ICMJE-defined clinical trials (not limited to drug and device interventions) at or before the time of first patient consent for enrollment as a condition of consideration for publication. If first patient consent for enrollment was prior to July 1, 2005, registration is required prior to journal submission.
- The ICMJE has a broader definition of clinical trial than NIH, which may include NIH-defined Basic Experimental Studies with Humans (see 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.
- 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).
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 participant. If this occurred prior to July 1, 2005, registration is required prior to journal submission.
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. Refer to the SOP linked at the top of this page for further information.