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Submitting Amendments & Requests for Renewals/ Closures of REB files to the UHN REB

Submitting Amendments & Requests for Renewals/ Closures of REB files to the UHN REB. Overview of presentation. Amendment What to submit How to submit Requests for Renewals/Closures. Amendment- definition.

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Submitting Amendments & Requests for Renewals/ Closures of REB files to the UHN REB

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  1. Submitting Amendments & Requests for Renewals/ Closures of REB files to the UHN REB 24Apr2013

  2. Overview of presentation Amendment What to submit How to submit Requests for Renewals/Closures 24Apr2013

  3. Amendment- definition Amendment- changes to the planning or conduct of approved studies including but not limited to any change to any REB-reviewed study documents that affects the design or conduct of a study, and may represent a change in known risks to study participants 24Apr2013

  4. Amendment vs. New study Sub-Study Significant changes in Study objectives Study population Study intervention will require a new submission 24Apr2013

  5. Amendment Do & Do NOTs Updated Consent Forms/ Addendums/ Informational Letters Delegated vs. Full Board type of review Amendment Forms 24Apr2013

  6. Requests for Renewals/Closures Progress of any study must be reviewed by the REB annually! (at least) Renewal Application Form/Annual Form REB Study File Closure Form/ Termination Form Notice of Late Submission 24Apr2013

  7. For More Information UHN REB Intranet Webpage UHN Research External Webpage 24Apr2013

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