CTCAE Conversion from v4.0 to v5.0 in NRG Oncology Trials
On March 31, 2018, CTEP IT infrastructure will migrate to CTCAE v5.0.
Effective April 1, 2018, all patient data submitted to CTEP must use CTCAE v5.0. This migration affects sites submitting data for NRG Oncology studies in the following ways:
For active studies and studies closed to accrual that do not have a CTSU protocol status of "complete"*:
Beginning April 1, 2018:
CTCAE v5.0 will be used for CTEP-AERS reporting.
All study CRFs will continue to use CTCAE v4.0, until sites are instructed otherwise via protocol amendments. (NRG is considering the possibility of migrating select active trials to CTCAE v5.0 for CRFs. If a decision is made to migrate trials to v5.0 for CRF reporting, NRG will issue protocol amendments on a trial-specific basis.)
Protocol NRG-GY006 was activated on January 15, 2016, with the original pilot of the RAVE-CTEP-AERS integration. This original integration provided a CTEP-AERS rule evaluation for routine AEs reported in RAVE. This rule evaluation will be removed from the GY006 RAVE study build with the migration to CTCAE v5. Routine AE data will continue to be entered on the AE RAVE forms. Adverse events requiring expedited reporting will continue to be entered via CTEP-AERS.
NRG will amend these protocols to update the AE/SAE reporting language per the above throughout 2018.
* Status per CTSU member website, reflecting that the protocol has been closed to accrual, all patients have completed therapy, and the study has met its primary objectives.
Exceptions to the above instructions include the following trials which utilize the CTEP-AERs/Rave integrations:
Due to already established CTEP-AERs/Rave integrations for the following trials, all AE reporting will remain in CTCAE v4.0 on April 1, 2018. NRG will release protocol amendments for all AE/SAE reporting by July 1, 2018; these amendments will be coincident with a full migration to v5.0 for each specific protocol.