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Protocol Application Process Investigators who wish to apply for our support need to submit the following materials to us: Please e-mail to UW-GCRC Protocol Manager Danielle Gale (dgale@biostat.wisc.edu): 1. The GCRC Addendum to the HSC Application 2. Data and Safety Monitoring Plan. For detailed information and forms click here. 3. The Institutional Review Board (IRB) Initial Review application, with draft consent form(s) and any other attachments provided to the IRB or, if applicable, the most recent Change of Protocol application, as submitted to the IRB. These forms can be accessed from here. [For studies already approved by the IRB, include the IRB Notice of Action – Approval, the IRB-stamped consent form(s) and HIPAA authorization with your paper copies.] 4. The most current sponsor protocol/grant application. 5. Other pertinent materials [e.g., draft orders, PI biosketch (if a new investigator to the UW-GCRC), communications, RSP-approved budget, etc.] These can all be submitted as separate "files", and do not have to be incorporated into one file. Adobe Acrobat/Reader (pdf) and Word (doc, rtf) files are recommended. AND PAPER COPIES: Please submit one (1) unstapled, single-sided "original" of all the above (with signatures on the DSMP and IRB application) and 11 stapled, double-sided copies (please staple all sections into 1 document, do not staple individual sections) of the same. If the study has already received IRB approval, please include a copy of the IRB Notice of Action – Approval, the IRB-stamped consent form(s) and HIPAA authorization with the "original" copy. If you have any attachments that you are NOT able to submit electronically, please separate those documents with a clip and indicate that they were not included in the electronic application. Please keep this to less than 20 pages.
*** REVISED MARCH 2007 *** 2007 Deadlines for Protocol Submissions to the GCRC
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