NOTICE OF ADVERSE REACTIONS REPORTING REQUIREMENTS

Effective immediately, there are new adverse event reporting requirements. These requirements are meant to clarify the differences in reporting on-site versus off-site adverse events.

ON-SITE REPORTING REQUIREMENTS:
(An on-site event is one that occurs to a subject enrolled on an IUPUI or Clarian protocol).

• Must report ONLY SERIOUS AND UNEXPECTED adverse reactions associated with study intervention to Research and Sponsored Programs within 3 working days of notification of the event
• Must report ALL deaths that occur within 30 days of study intervention within 3 working days of notification of the event.

OFF-SITE REPORTING REQUIREMENTS:
(An off-site event is one that occurs to a non-IUPUI/Clarian research subject).

• Must report ONLY SERIOUS AND UNEXPECTED adverse reactions associated with study intervention within 10 working days of receipt from the sponsor.
• Must report ALL deaths that occur within 30 days of study intervention within 10 working days of receipt from the sponsor.

Any adverse reactions that do not meet the above reporting requirements may be reported at the time of continuing review or via Independent Data and Safety Monitoring Board reports.

All adverse reactions meeting the above reporting requirements must be reported on the Adverse Reaction Reporting Form.

After January 31, 2001, Adverse Reaction Reporting Forms will be returned for the following reasons:

• The form is incomplete.
• The adverse reaction(s) being reported does not meet the above reporting requirements.
• The adverse reaction report is not received on the standard Adverse Reaction Reporting Form.

Please contact Research and Sponsored Programs (274-8289) if you have further questions.

IUPUI Research and Sponsored Programs
Last Update: December 14,2000
http://www.iupui.edu/~resgrad/spon/adverse-reprot-notice.htm