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Form must be populated using Adobe Acrobat / Pro 9 or greater standalone program (do not fill out in browser). Hand written forms will not be accepted. 1. Todays Date FORMTEXT       2. Principal Investigator (PI) Principal Inves. (title): FORMTEXT      Faculty PI (if PI is a student): FORMTEXT       Department: FORMTEXT      Department: FORMTEXT       Phone: FORMTEXT      Phone:  FORMTEXT       AU E-mail: FORMTEXT      AU E-mail: FORMTEXT      Contact person who should receive copies of IRB correspondence (Optional) Name: FORMTEXT      Department Head: FORMTEXT       Phone: FORMTEXT       AU E-mail:  FORMTEXT        3. AU IRB Protocol Identification  3.a. Protocol Number FORMTEXT       3.b. Protocol Title  FORMTEXT       3.c. Current Status of Protocol For active studies, check ONE box at left; provide numbers and dates where applicable FORMCHECKBOX  Study has not yet begun; no data has been entered collected FORMCHECKBOX   FORMCHECKBOX  In progress If YES, number entered Adverse events since last review Data analysis onlyApproval Dates: From FORMTEXT       To  FORMCHECKBOX  Funding Agency and Grant Number:  FORMTEXT       AU Funding Information:  FORMCHECKBOX  List any other institutions and/or IRBs associated with this project:  4. Types of ChangeMark all that apply, and describe the changes in item 5 FORMCHECKBOX Change Key Personnel Attach CITI forms for new personnel. FORMCHECKBOX Additional Sites or Change in Sites, including AU classrooms, etc. Attach permission forms for new sites.  FORMCHECKBOX  Change in methods for data storage/protection or location of data/consent documents  FORMCHECKBOX  Change in project purpose or project questions  FORMCHECKBOX  Change in population or recruitment Attach new or revised recruitment materials as needed; both highlighted version & clean copy for IRB approval stamp  FORMCHECKBOX  Change in study procedures Attach new or revised consent documents as needed; both highlighted version & clean copy for IRB approval stamp  FORMCHECKBOX  Change in data collection instruments/forms (surveys, data collection forms) Attach new forms as needed; both highlighted version & clean copy for IRB approval stamp FORMCHECKBOX  Other (BUAs, DUAs, etc.) Indicate the type of change in the space below, and provide details in Item 5.c. or 5.d. as applicable. Include a copy of all affected documents, with revisions highlighted as applicable.  FORMTEXT       5. Description and Rationale 5.a. 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Additional pages may be attached if needed to provide a complete response.   FORMTEXT      5.b. Briefly list (numbered or bulleted) the activities that have occurred up to this point, particularly those that involved participants.   FORMTEXT      5.c. Does the change affect participants, such as procedures, risks, costs, benefits, etc.   FORMTEXT      5.d. Identify any changes in the safeguards or precautions that will be used to minimize described risks.  FORMTEXT      5.e. Attach a copy of all  stamped IRB-approved documents currently used. 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