Consortium News

Changes to IRB Policy 1.9 Noncompliance

November 30, 2013 - IRO News: Changes to IRB Policy 1.9 Noncompliance
Administering a drug at a dose or schedule not approved by the IRB must be reported to
the IRB. The policy has been updated to reference reporting when the administration of
radiation, biologics, cell products or use of devices does not follow protocol required
specifications.

The clarification can be found on page 2 and 4, bullet point 4 in IRB Policy 1.9
Noncompliance.

The corresponding IRB Policy 1.11 Reporting Obligations for Principal Investigators has been similarly updated.

IRB Policy 1.9 Noncompliance and IRB Policy 1.11 Reporting Obligations for Principal
Investigators can be found at the following links:

CenterNet and ExtraNet

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