w88 trials investigator-initiated research

w88 Trial Registration – New Study Investigator-initiated

1. w88 Integrity & Security'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 w88.
2. The Research 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 w88 Research Coordinator (CRC) when applicable.
3. If there is no w88 Research Coordinator assigned to the study, initial data entry will be completed by the Research Integrity & Security 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.
4. Standardized w88 entry across studies is required for the following w88 fields:
   1. w88 Contact:
      Ada Diaconu-Muresan
      diaconum@unr.edu
      (775) 327-2373
      1661 N. Virginia Mailstop 0331
      w88 of Nevada, Reno, Reno, NV 89557
   2. w88 Contact = Principal Investigator
   3. Central Contact Backup = w88 Research Coordinator (CRC) or Principal Investigator in the absence of a CRC
   4. Overall w88 Official = Principal Investigator in most instances
   5. Facility Contact = Principle w88
   6. Facility Contact Backup = w88 Research Coordinator (CRC) or Principal Investigator in the absence of a CRC
5. The PI w88 be assigned a new user account and record ownership once the record is created.
6. The w88 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 w88 identifies corrections or changes needed, the w88 may
   1. forward the requested changes to the w88 Research Assistant or the Research Integrity & Security PRS Administrator to update the record, or
   2. update the record and notify the w88.
8. Once data entry content is finalized within the University, the w88 Integrity & Security PRS Administrator will release the record to Central PRS administrative review.
9. Record will be approved and published by Central w88 administration or feedback with requested revisions will be entered in the system.
10. In consultation with protocol w88 staff, the w88 Integrity & Security PRS Administrator will agree on and respond to revisions requested by Central PRS administration.
11. The w88 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 w88 publishes the study.