Submit the following items to the Research Office at least two weeks prior to the anticipated WSU Institutional Review Board (IRB) meeting (see Deadlines information on the following link: http://www.wright.edu/rsp/subjects.html):
Research Application. The following are required for all submissions.
CITI Training Completion Report (Dayton-552) (As of October 2010, this training is to be completed Biannually.)
Investigator Data Sheet (Form 10-5368) (01/1992), page 18: [ONLY required for first time VA investigators]
Updated Curriculum Vitae (CV) (electronic version) or Resume: ONLY required for first time VA investigators or if not on file in Research Office
Protocol or Proposal
Abstract of Protocol or Proposal
Scope of Practice Forms for Each Investigator (Including Primary Investigator) (06/2010) [ONLY Primary Investigators must include their supervisor's signature.]
Human Subjects. The Human Studies Subcommittee (Institutional Review Board-IRB) must review and approve all such projects. WSU IRB review and full approval must occur before the R&D review.
FDA 1572 Statement of Investigator (05/2006)
Research Patient Data Protection Agreement (11/2006)
(This document must be signed and submitted with the application)
If applicable, the following (# copies) are required:
All proposed advertising and recruitment material (e.g. flyers, circulars)
All questionnaires, data collection forms etc.
Investigator's Brochure (for drug trials)
If VA Pharmacy / Research Pharmacy used:
Investigational Drug Information Record (VA Form 10-9012) (11/1989), one for each investigational drug (includes any comparator drug as well as an approved drug for an unapproved dosage, indication or route)
Memo of Pharmacy support may be needed if drug not supplied
Investigational Device Information