IRB Submission Reminder List for an Addendum Please review your IRB submission for completeness of all the required items This will facilitate review of your submission and ensure a ti by RMhfl66

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									             IRB Submission Reminder List for an Addendum
Please review your IRB submission for completeness of all the required items. This will
facilitate review of your submission and ensure a timely approval. This checklist is designed as
an aid in preparing your submission. You do not have to submit this form.

For an Addendum
Did you remember to . . .

□ Complete an IRB Checklist – Protocol Addendum (A).    Be sure all relevant items are
   completed on the checklist. Note: You must have a valid approval for the protocol in order
   to submit an addendum.
□ Be sure the contact information, especially email address, is correct and up-to-date.
□ Obtain all the required signatures on the Investigator’s Checklist.
□ Include a brief memo summarizing the changes you are submitting for this addendum. A
   copy of the sponsor’s memo is not sufficient. If you are planning to reconsent subjects as a
   result of this change, please indicate this in your memo.
□ If changes to the protocol and/or consent form increases subject risk, the addendum must
   have departmental review and approval. Include a copy of your department approval with
   your submission. In addition, please indicate in your memo the nature of the increased risk.
□ If you are changing the consent form, please submit a copy of the currently approved consent
   form, a copy of the consent form with the changes clearly highlighted or underlined, and a
   clean copy of the updated consent form for stamping. A list of changes is not sufficient.
□ Double check your revised consent form for correct spacing, headings, and updated standard
   research consent language.
□ Provide an updated copy of the protocol if you are making changes to the protocol. Clearly
   indicate changes to the protocol by underlining or highlighting the changes.
□ Proofread the submission (especially the consent form) for grammar and typographical
   errors.
□ Submit original complete set of all materials and one copy. Do not use paper clips or
   binders. Please staple together materials if possible. Do not copy your submission on both
   sides or put in binders or folders.
□ Place the Protocol Addendum Investigator’s Checklist (A form) as the first item in your
   submission packet.




                                                                                  Version 8/2005

								
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