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Data Repository Review
1 copy of each of the following documents should be delivered to our office. You can also view/print this checklist from a word document.
Items Required for EVERY Study - All forms are in MS Word except where noted
ü One of the Following:
Investigators Protocol: Guidelines for developing the Protocol
NIH Grant Application (If study is supported by NIH, a copy of the grant application must be submitted)
Cooperative Group Protocol
Sponsor's Protocol (for commercially sponsored studies)
Items Required if applicable to Study - All forms are in MS Word except where noted
ü Any Applicable Attachments:
| 1. Additional Investigators List | |
| 2. Studies Involving Minors | |
| 7. Request for Expedited Review | |
| 8. Request for Waiver of Informed Consent/HIPAA |
ü All data collection tools
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