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 decides 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 decision. 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?
- 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
- 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 email@example.com for help.
- 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 (link above).
- Studies that may be subject to the International Committee of Medical Journal Editors (ICMJE) Clinical Trial Registration Policy.
- Generally, the study should be registered if it meets the ICMJE definition of clinical trial and there is intent to publish the study results.
- 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.
- Clinical trials subject to the Centers for Medicare and Medicaid Services (CMS) Change Request 8401.
- Studies for which there are otherwise funding agency or collaborator requirements (review the grant and/or contract for your study).
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?
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.
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 firstname.lastname@example.org 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 email@example.com.
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 (verify NCT number assigned and posted on public site) prior to informed consent of the first subject.