Cover Letter - WIRB Initial Review

Post CIRB Approval / Submission to UCD Cover Letter

InfoEd # PI Name & Cell Phone or Pager #: Primary Contact Name & Cell Phone or Pager #

Is there any non-standard language in the boilerplate language?  YES, or  NO If yes, has the requested non-standard language been pre-approved by UCD?  YES, or  NO

Have all personnel been added into InfoEd? YES, or NO

The following documents are required for initial review submission:

CIRB Approval of Study-Specific Worksheet Protocol (date: ) CIRB Approved Informed Consent Form with Boiler Plate Addendum PRMS Approval Letter UCD/UCH Clearance Letter

Please indicate any of the following being utilized as a site:

UC Health Central (UCH) YES, or NO University of Colorado Denver YES, or NO Children’s Hospital Colorado YES, or NO Children’s Hospital Colorado at Memorial Central YES, or NO UC Health North (Poudre Valley) YES, or NO UC Health South (Memorial) YES, or NO Lone Tree YES, or NO - If yes, is this study eligible to utilize Lone Tree? YES, or NO TomoTherapy (Radiation Therapy in Lone Tree) YES, or NO - If yes, is this study eligible to utilize Lone Tree? YES, or NO Are there any other locations? YES, or NO

- If yes, please list: CIRB Initial Review Cover Letter Effective 8/27/2014  If any changes to local sites, personnel or the boilerplate language are made to this study after initial approval, please submit the CIRB Change Form to [email protected].  If changes are made to the boilerplate language please attach a highlighted and clean copy of the informed consent form with the boilerplate language.  If there are any personnel changes please revise the Personnel –Section C form in InfoEd.

 All other CIRB approved changes/updates do not need to be submitted for local review.

______Research Staff Signature Date

The following section will be completed by UCD staff

1. Have all COMIRB education requirements been completed by all study staff?  YES, or  NO – if no, study review cannot go forward.

2. Is the UCD/UCH Clearance Letter included with the submission?  YES, or  NO

3. Are there any Conflicts of Interest issues to be disclosed for the investigators or key personnel that relate to this study?  YES, or  NO If yes: a. Who has the potential conflict: b. Is the COI Information Form included with the submission?  YES, or  NO c. Has a COI Management Plan been developed?  YES, or  NO

Date received by UCD Administration: CIRB Initial Review Cover Letter Effective 8/27/2014 Date approved by UCD Administration:

CIRB Initial Review Cover Letter Effective 8/27/2014