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Clinical Trial Registration – New Study Investigator-initiated
- Research Integrity's Protocol Registration System (PRS) Administrator will confirm that the study requires registration in ClinicalTrials.gov, and that the University’s site is the site that must register the study.
- The Research Integrity PRS Administrator will register new users in the system, including the Principal Investigator (PI) for data entry review and verification, and the designated Clinical Research Coordinator (CRC) when applicable.
- If there is no Clinical Research Coordinator assigned to the study, initial data entry will be completed by the Research Integrity PRS Administrator, using the protocol submission and IRB review records in IRBNet, and consultation with research staff when required data elements are not provided in the protocol submission.
- Standardized data entry across studies is required for the following data fields:
- IRB Contact:
1661 N. Virginia Mailstop 0331
University of Nevada, Reno, Reno, NV 89557
- Central Contact = Principal Investigator
- Central Contact Backup = Clinical Research Coordinator (CRC) or Principal Investigator in the absence of a CRC
- Overall Study Official = Principal Investigator in most instances
- Facility Contact = Principle Investigator
- Facility Contact Backup = Clinical Research Coordinator (CRC) or Principal Investigator in the absence of a CRC
- IRB Contact:
- The PI will be assigned a new user account and record ownership once the record is created.
- The Research Integrity PRS Administrator will request that the study PI log in to review the study record prior to release to Central PRS administrative review.
- If the PI identifies corrections or changes needed, the PI may
- forward the requested changes to the Clinical Research Assistant or the Research Integrity PRS Administrator to update the record, or
- update the record and notify the PRS Administrator.
- Once data entry content is finalized within the University, the Research Integrity PRS Administrator will release the record to Central PRS administrative review.
- Record will be approved and published by Central PRS administration or feedback with requested revisions will be entered in the system.
- In consultation with protocol research staff, the Research Integrity PRS Administrator will agree on and respond to revisions requested by Central PRS administration.
- The Research Integrity PRS Administrator will release the record again to Central PRS administrative review.
- The process will repeat if needed from step 6 until Central PRS publishes the study.
Regulations and Guidance
- Office for Human Research Protections (OHRP) – Belmont Report
- FDA Regulations Relating to Good Clinical Practice and Clinical Trials
- Clinical Trials and Human Subject Protection
- FDA Guidance for Industry: Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects
- Expanded Access (Compassionate Use)
Clinical Trials Definition and Registry
- NIH Clinical Trial Requirements for Grants and Contracts
- Clinical Trial Registration – Basics