EXPEDITED REPORT SUBMISSION

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In January 2001, the NCI implemented the Adverse Event Expedited Reporting System (AdEERS). AdEERS is an electronic system developed by the Cancer Therapy Evaluation Program (CTEP), NCI for the expedited submission of adverse event reports. A link to the AdEERS Website is available in the Adverse Events section of the CTSU Registered Members Website and on the CTEP Website.

The AdEERS reporting tables in the protocol document will indicate (1) when adverse events require expedited reports, and (2) which report options to follow.

Follow the process below for either NCI investigational agent(s) or Commercial agent(s). Specific protocols may request a report format that applies to commercial agents only.

NOTE: AdEERS is only used for serious adverse events.

Reporting Steps for Investigational Agents
Refer to time frame required by the protocol.
Complete and submit a report via the Adverse Event Expedited Reporting System (AdEERS).
Once submitted, the AdEERS report is automatically delivered to one of the following (decided by the lead Group, not the local investigator):
 

The lead Group for centralized reporting where Groups review the report and, if deemed a reportable event, forward it to the NCI.

 

NCI for decentralized reporting where the report will be delivered to the NCI for review and released to the lead Group.

If electronic submission is not feasible:
As of 2003, all AdEERS reporting must be done on-line, the paper templates used in the past have been retired.
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Reporting Steps for Commercial Agent(s) only
 
The CTSU site will follow the process below, as stated in the protocol document. This is essentially the same process used with investigational agents.
Submit the report via the commercial agent track within the Adverse Event Expedited Reporting System.
Complete and submit an electronic AdEERS report within the time frame specified in the protocol.
Once submitted, the AdEERS report is automatically delivered to either the lead Group (centralized reporting) or the NCI (decentralized reporting). Groups following the centralized reporting method review the report and, if deemed a reportable event, forward it to the NCI. The NCI will be responsible for the report submission to the FDA. If the Group follows the decentralized reporting method, the report will instead be delivered to the NCI for their review and then released to both the lead Group and the FDA.
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