WIRB Initial Review Cover Letter (REQUIRED)
IRB #:
- InfoEd number obtained from the InfoEd Human Subjects Database. See “How to Submit to WIRB” instructions on COMIRB website.
PI Name & Cell Phone or Pager #:
Primary Contact Name & Cell Phone or Pager #
Speed Type for Contract #:
Billing/Financial Specialist Contact Name & E-mail:
Back-Up Speed Type for Dept (UCH and UCD-AMC only):
Is this a CPU (CTO/WIRB Fast-Track) study? q YES, or q NO
Is this study utilizing CTO? (For Cancer Center only) q YES, or q NO
Or Indicate Institution to be invoiced: q Denver Health or q Children’s Hospital Colorado
Is there any non-standard consent form language? q YES, or q NO
If yes, has the requested non-standard language been pre-approved by UCD? q YES, or q NO (Note: The study cannot move forward to WIRB until pre-approval of non-standard language has been received.)
The following documents are required for initial review submission—check all that are included:
q Completed WIRB Initial Submission Form q WIRB Eligibility Checklist
q Protocol (date: ) q WIRB HIPAA Eligibility Checklist
q Informed Consent Form in UCD/WIRB format q Personnel Sheet
q Informed Consent Form – Sponsor Template (if applicable)
q IND or IDE Documentation (if applicable)
q Signed FDA Form 1572 (if applicable) with WIRB listed as the IRB
q Documentation of pre-approved non-standard language (if applicable)
q HIPAA Authorization(s) in UCD Format (if applicable)
Please note the following instructions:
· Include this signed form with your submission to WIRB.
· Follow WIRB policy to ensure you submit all required documents to WIRB for review.
· All initial and 12-month invoices generated by WIRB must be sent to Marie Wade at:
Marie Wade, MS F497
Financial Manager, Regulatory Compliance
University of Colorado Anschutz Medical Campus
13001 E 17th Place, 1st Floor, Room W1124
Aurora, CO 80045
· If any changes to local sites, personnel or HIPAA are made to this protocol after initial approval, please submit the WIRB Change Form with a revised personnel sheet and/or highlighted and clean copy of the HIPAA form(s) (if applicable) to
· For all updates or changes to the study, submit directly to WIRB per their policy.
_ _____
Research Staff Signature Date
The following section will be completed by UCD staff
1. Have all UCD education requirements been completed by all study staff?
q YES, or q NO – if no, study review cannot go forward.
2. Is the study eligible for WIRB?
q YES, or q NO – if no, study review cannot go forward.
3. If DHHA is listed as a study site, is their clearance letter included in the submission?
q YES, or q NO – if no, study review cannot go forward.
4. Are there any Conflicts of Interest issues to be disclosed for the investigators or key personnel that relate to this study?
q YES, or q NO
If yes, list who has the potential conflict:
Has a COI Management Plan been developed?
q YES, or q NO
Date received by UCD Administration:
Reviewed and approved for submission to WIRB by:
UCD Administrative Staff Signature Date
Date sent to PI: ________________________________________________________________
By signing this form, the UCD staff attests that this protocol is ready for submission to WIRB.
WIRB Initial Review Cover Letter
CF-029, Effective 9-10-2014