Canadian Cancer Trials Group Bulletins

Ethics Regulatory

Changes to Adverse Event Expedited Reporting System

The Cancer Therapy Evaluation Program (CTEP) has made changes to the Adverse Event Expedited Reporting System (AdEERS) as outlined below. Please note, the generic protocol has been updated accordingly and relevant existing protocols should be updated at the time of the next amendment.

1. AdEERS Application:
In the rare event that internet connectivity is disrupted, a 24-hour notification is to be made to NCI by telephone at: 301-897-7497. In such circumstances, please also notify by phone the Canadian Cancer Trials Group study coordinator for the trial. An electronic report MUST be submitted immediately upon re-establishment of internet connection. Please note that all paper AdEERS forms have been removed from the CTEP website and will NO LONGER be accepted.

2. Secondary Malignancies (including AML and MDS):
A secondary malignancy is a cancer caused by treatment for a previous malignancy (e.g., treatment with radiation or chemotherapy). A secondary malignancy is not considered a metastasis of the initial neoplasm. A secondary malignancy is unrelated to the first cancer that was treated, and may occur months or even years after initial treatment.

CTEP has removed the old AML/MDS form from its website. All secondary malignancies that occur following treatment with an agent under an NCI IND must be reported via AdEERS. CTCAE v4.0 has three options available to describe treatment-related events:
  • Leukemia secondary to oncology chemotherapy
  • Myelodysplastic syndrome
  • Treatment related secondary malignancy

3. Upcoming AdEERS table changes:
The FDA has recently revised its requirements for safety reporting for its IND (investigational) studies. As a result, NCI US-affiliated protocols in development or those which will be approved after March 28, 2011 will require new AdEERS tables which indicate serious, related events must be reported (i.e. are protocol reportable). CTEP expects current protocols will not be affected.

There is a NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS that can be found at: This document is full of good information regarding basic terminology for AE reporting and basic information about CTCAE, CAEPRs and HIPAA. The updated AdEERS tables can be viewed within this document as well.

Any questions about this should be directed to Bryn Fisher, ER Team Leader, at 613-533-6430 or .