Convened Continuing Review Checklist s1

Department for Human Research Protections UT Institutional Review Boards Center for Creative Education Building, Rooms 0106 3025 Arlington Avenue, Toledo, Ohio 43614-5804 Phone: 419-383-6796 Fax: 419-383-3248

CONVENED CONTINUING REVIEW CHECKLIST

Please obtain all required signatures; Applicant(s), Faculty Advisor, Department Chair or Dean. Use the following checklist to ensure you are submitting a complete application to prevent delays in the review process. Incomplete applications will be returned.

If requesting Amendments or Modifications at the time of continuing review, you may incorporate them into the continuing review application under Section G. Amendment/Revision Request.

Please submit the following items to the IRB office: One (1) original and two (2) copies of the application with all pertinent attachments. The original is for the institutional file and the copies are sent to the primary reviewers. A disc or CD of the entire packet or an electronic version to [email protected] Please include the following items: The current research protocol - If revising a currently approved protocol, please submit current protocol and proposed protocol with all changes highlighted. The current consent/authorization/assent form(s) - If revising a currently approved consent/assent form, please submit current form and proposed form with all changes highlighted. If you are updating a currently approved Investigator Brochure, submit the revised IB or safety information with all changes from previous version highlighted. An updated Adverse Event Summary Table with all internal or external reporting forms and DSMB or DMC report for multi-centered trials. A Literature Review – Please submit a list of the current, pertinent literature, summarize relevant conclusions from the literature cited, and provide your assessment of any change in the risk: benefit ratio and the value of continuing the study. Any other documents the P.I. (or sponsor) believe are important for IRB review such as new IRB approval letters from other sites, recruitment materials etc. New permission letters from performance sites. New study personnel Research Training Verification forms.

All IRB submission forms can be found on the DHRP home page: http://utoledo.edu/research/RC/HumanSubs_Menu.html

Convened Continuing Review Checklist Version date: 04/07/2009