UPDATE: The amendment form has been reformatted to allow for special characters in all text fields. The new version is labeled April 2008 and is effective immediately. Please refer to the emails to IRB contacts dated 4/9/08 and 4/17/08 for more details about the amendment form changes.

The amendment form version dated APRIL 2007 will only be accepted for amendment submissions through April 22, 2008.

The new amendment form is posted on the Amendment forms page.

4/11/08, update 4/17/08

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The IRB meeting and deadline dates have been posted through December 2008. Please see the Submission and Meeting Dates page for a complete list of dates.

Note that the deadlines for new protocols and amendments have been moved to Tuesdays beginning with the January meeting deadlines.

3/31/08

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Supplemental form H has been revised to reflect updated language from the RADRAC. This form version is dated December 2007 and is effective immediately. Please see the Forms page for the most recent version of all IRB forms, including supplemental form H.

1/10/08

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The IRB has recently revised its reporting policy for adverse events not occurring at this site. External adverse events meeting the reporting requirements of (1) serious (2) unexpected and (3) related or possibly related to the research should now be reported within 30 working days of investigator knowledge of the event. Note that any unexpected adverse event that occurs on a device trial (regardless of seriousness or causality) must continue to be reported to the IRB within 10 working days of the investigator’s knowledge of the adverse event.

The External Adverse Event reporting form has been revised to reflect this change in policy. The policy and form should be implemented immediately.

The updated External AE form is dated MAY 2007 and is available on the Forms page.

6/13/07

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