Canadian Cancer Trials Group Bulletins

Office of Compliance and Oversight

Expedited Reporting of Adverse Events to CTEP via AdEERS

The Cancer Therapy Evaluation Program (CTEP) often receives Adverse Event Expedited Reporting System (AdEERS) reports for adverse events that do not meet the criteria for expedited reporting. Therefore, please review the information below to reduce site and CTEP staff time and administrative costs associated with receiving and processing AdEERS reports.

Expedited reporting should be considered for events that are serious (results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, is an important medical event).

In addition, please refer to the following for details of what constitutes an expedited report (AdEERS):
  • The protocol, which may include protocol-specific events of interest requiring expedited reporting and/or protocol-specific exceptions (Specific Protocol Exceptions to Expedited Reporting (SPEER) found in the Comprehensive Adverse Events and Potential Risks list (CAEPR) for each CTEP investigational agent;

  • Canadian appendix to address Canadian specific requirements that may differ from the protocol; and,

  • NCI Guidleines for Investigators: Adverse Event Reporting Requirements for DCTD (CTEP and CIP) and DCP INDs and IDEs (section 4.0; Appendices 1 and 2) located at:

Questions regarding expedited reporting of adverse events should be directed to the Canadian Cancer Trials Group study coordinator for the trial.