What's New on Legacy Applications
Click on the date in the table below to review the detailed information.|
New Project Application |
Prev. Approved Project App. |
Emergency Use Report |
ENGAGE-only Application |
Request Form: |
Request Form: Waiver of Documentation of Consent |
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This form is no longer valid. Use eResearch. |
This form is no longer valid. Use eResearch |
This form is no longer valid. |
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Previously Approved Project Application October 2, 2007The instructions and section 6 were updated in connection with the new guidance for reporting of external adverse events. Click here to see a marked up copy of the application changes.
Previously Approved Project Application April 12, 2007The instructions were modified to make it clearer that an electronic copy on CD or disk must be submitted with an application.
Previously Approved Project Application December 4, 2006The definition of 'unexpected' provided in Section 6 was changed to be consistent with the new web-posted guidance for adverse events. CURRENT: Unexpected: An event that has not been addressed or described in one or more of the following: Informed consent document(s) for this study IRB application for this study Grant application or study agreement Protocol or procedures for this study Investigators' brochure or equivalent (for FDA regulated drugs or devices) DSMB/DSC Reports Published literature PRIOR TO 12-4-06 Unexpected: Not included in consent document under “Risks”. . Previously Approved Project Application May 6, 2006The 'completeness checklist' at the end of the application was deleted. Previously Approved Project Application March 25, 2006Inconsistencies in the instructions related to subject interactions/involvement (versus recruitment) and when a copy of the previously informed consent document should be submitted were resolved. Previously Approved Project Application January 4, 2006The AE/ORIO links in the application were repaired. No other changes were made.
HIPAA Waiver Forms—Changes made June 8, 2005: A note was added indicating that these forms are not required if using eResearch Engage-Only Project Application—Changes made April 21, 2005:The instructions were changed to indicate that we will accept the Engage-Only Project Application for studies in Legacy (the paper-based system) until a study is converted to eResearch. Studies initiated in eResearch should submit an amendment in eResearch to add an Engage posting in section 8. New Project Application—Changes made March 28, 2005:
Questions relating to the use of FDA controlled agents were revised in sections 7, 14 and 15. Click here to review the specific changes. All Applications—Changes made February 2, 2005:
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IRBMED Address changed throughout to: Argus I Building 517 W. William |
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