PROTOCOL NRG-GI003 and NRG-GU005 CTCAE v 5 Conversion for CRFs

As previously broadcast on March 29, 2018, NRG-GI003 and NRG-GU005  were converted from CTCAE v 4 to v 5 for CTEP-AERS reporting beginning April 1, and all study case report forms (CRFs) were to remain in v 4.

Beginning May 10, 2018 , all adverse event reporting for NRG-GI003 and NRG-GU005 in CRFs will be collected in CTCAE v 5.

A copy of the CTCAE version 5.0 can be downloaded from the CTEP website.

The protocol  will be revised at the next amendment to reflect the conversion.

Please distribute this information to the appropriate personnel at participating affiliate/NCORP component institutions.

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