Protocol Submission Checklist

Protocol Submission Checklist Protocol Title: Submitter: Date:

Mandatory documents for all IRB new submissions (exceptions noted):

Leave the submitter check box blank if the section is not applicable. Submitter Check Box RSPP Office Use Only Written administrative acknowledgment from Aurora Research Institute

Research Certification for each Investigator/Key Personnel must be on file with the IRB (http://www.aurorahealthcare.org/misc/irb/index.asp) OR

NIH Tutorial (acceptable for exempt submissions only) (Log in here: https://phrp.nihtraining.com/users/login.php)

Conflict of Interest completed using COI-Smart (Log in here: https://aurora.coi-smart.com/login.php) All Investigators/Key Personnel conducting any research activities (as delegated by the Principal Investigator) are required to comply with Aurora IRB policy GA 104. Submission Form with Principal Investigator signature (electronic via .pdf)

Complete protocol (either from sponsor or written by investigator) Indicate Version/Date: (N/A for Exempt submissions) Grant application when Aurora is the awardee institution

(N/A for Exempt submissions) PI’s current CV

(N/A for Exempt submissions or when requesting waiver of informed consent) Informed consent document using Aurora IRB’s recommended template language (Word document) OR (When applicable) Information sheet (Word document) (When applicable) Sponsor’s sample informed consent document

(N/A for Exempt and Medical Record Submissions) Delegation of Authority log The IRB office requires a copy of the DOA log signed by the PI at the time of submission, but does not require the signatures/initials of each delegate for the IRB file. However, the site must maintain properly executed original logs for the duration of the study and have them available upon request. (If applicable for protocol; N/A for Exempt submissions) Investigator’s Brochure, Package Insert, or Device Operator’s Manual Indicate Version/Date: (If applicable to protocol) Data collection tool or case report forms

(If applicable to protocol) All materials to be seen by subject (recruitment materials, diaries, information cards, etc.)

(If applicable to protocol) Surveys, questionnaires

(If applicable to protocol) Form SC 502A for Preparatory to Research Activities

Form FO 301A vr. 9/9/2014.2