Clinical trials investigator-initiated w88 casino

Clinical Trial Registration – New Study Investigator-initiated

  1. w88 casino Integrity & Security's Protocol Registration System (PRS) Administrator will confirm that the study requires registration inClinicalTrials.gov, and that the University’s site is the site that must register the study.
  2. The w88 casino Integrity & Security PRS Administrator will register new users in the system, including the Principal Investigator (PI) for data entry review and verification, and the designated Clinical w88 casino Coordinator (CRC) when applicable.
  3. If there is no Clinical w88 casino Coordinator assigned to the study, initial data entry will be completed by the w88 casino Integrity & Security PRS Administrator, using the protocol submission and IRB review records in IRBNet, and consultation with w88 casino staff when required data elements are not provided in the protocol submission.
  4. Standardized data entry across studies is required for the following data fields:
    1. IRB Contact:
      Ada Diaconu-Muresan
      diaconum@unr.edu
      (775) 327-2373
      1661 N. Virginia Mailstop 0331
      w88 casino, Reno, Reno, NV 89557
    2. Central Contact = Principal Investigator
    3. Central Contact Backup = Clinical w88 casino Coordinator (CRC) or Principal Investigator in the absence of a CRC
    4. Overall Study Official = Principal Investigator in most instances
    5. Facility Contact = Principle Investigator
    6. Facility Contact Backup = Clinical w88 casino Coordinator (CRC) or Principal Investigator in the absence of a CRC
  5. The PI will be assigned a new user account and record ownership once the record is created.
  6. The w88 casino Integrity & Security PRS Administrator will request that the study PI log in to review the study record prior to release to Central PRS administrative review.
  7. If the PI identifies corrections or changes needed, the PI may
    1. forward the requested changes to the Clinical w88 casino Assistant or the w88 casino Integrity & Security PRS Administrator to update the record, or
    2. update the record and notify the PRS Administrator.
  8. Once data entry content is finalized within the University, the w88 casino Integrity & Security PRS Administrator will release the record to Central PRS administrative review.
  9. Record will be approved and published by Central PRS administration or feedback with requested revisions will be entered in the system.
  10. In consultation with protocol w88 casino staff, the w88 casino Integrity & Security PRS Administrator will agree on and respond to revisions requested by Central PRS administration.
  11. The w88 casino Integrity & Security PRS Administrator will release the record again to Central PRS administrative review.
  12. The process will repeat if needed from step 6 until Central PRS publishes the study.