When assessing an Adverse Event, refer to the instructions and tables provided in the protocol by the sponsoring Cooperative Group. At the time of the event, some Groups require the site to contact the Group AE representative for guidance on assessment and reporting.
	Identify and grade the severity of the event, using the NCI Common Terminology Criteria for Adverse Events (CTCAE version 3.0) or the NCI Common Toxicity Criteria (CTC version 2.0), as indicated by the protocol. A link to the current CTC version is available on the Helpful Related Links page in the Resources section of the CTSU Registered Member Web Site. It is also available on the CTEP web site http://ctep.cancer.gov/reporting/ctc.html.
	Determine whether the Adverse Event is related to the medical treatment or procedure (attribution).
	Determine whether the event is expected or unexpected based on information provided in the drug information section of the protocol, the NCI Agent Specific Expected Adverse Event List, and/or the Investigator's Brochure. The NCI Agent Specific Adverse Event Lists are located on the AdEERS web site and are considered proprietary information which can be accessed only by individuals with a username and password. They are intended to provide feedback to the Investigator as to whether an event is expected for a particular agent.

There is a link to the AdEERS web site on the CTSU Registered Member Web Site under the Adverse Events tab (once you click on the tab scroll down into the page). It is also available on the CTEP web site http://ctep.cancer.gov/reporting/adeers.html.

Using the information gathered above, determine whether the event requires routine or expedited reporting. The table shown below indicates the typical requirements. Please consult the AE section of each protocol document for any additional protocol-specific requirements.

[Source: CTEP, NCI Guidelines: Adverse Event Reporting Requirements, available at http://ctep.cancer.gov/reporting/adeers.html.]

Complete the routine clinical assessment forms (i.e., the protocol-specific adverse event CRFs) available on the protocol-specific web pages of the CTSU Registered Member Web Site. Submit the CRFs and supporting documentation to the location specified within the protocol document (per regular data submission procedures).

The Adverse Events reporting section of the CTSU logistical appendix directs the site to the adverse events section of the main protocol for details on how to submit reports. Please note, the CTSU Data Operations Center should not receive, or be copied on, Serious Adverse Event reports.

Report all Serious Adverse Events to your local IRB in accordance with your local procedures.

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"Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND, or Investigational New Drug application, is the means through which the sponsor technically obtains this exemption from the FDA."

Source: Frequently Asked Questions About Drugs available at http://ctep.cancer.gov/reporting/ctc.html.

Investigational agents are study drugs administered under an Investigational New Drug Application. A commercial drug may be considered investigational if administered for indications other than those listed on the approved package label. Refer to the drug information section of the protocol to determine which drugs are considered investigational for that trial.

If a reportable event occurs on a treatment arm containing an investigational agent(s), submit the report via 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 web site is available by clicking on the Adverse Events tab of the CTSU Registered Member Web Site or the AdEERS tab of the CTEP web site (http://ctep.cancer.gov/reporting/adeers.html). AdEERS is programmed for both CTC v2.0 and CTCAE v3.0 and the appropriate version is automatically associated with the protocol selected in AdEERS.

Complete and submit an electronic AdEERS report within the timeframe required by the protocol. The CTSU should not be copied on these reports. Once submitted, the report is automatically delivered to either the Cooperative Group (via AdEERS centralized reporting) or the NCI (via AdEERS decentralized reporting). Groups following the centralized reporting method review the report and, if deemed a reportable event, forward it to the NCI. If the Group follows the decentralized reporting method, the report is instead delivered to the NCI for their review and subsequent release to the lead Group.

The 24-Hour Notification via AdEERS system was introduced by NCI on June 1, 2002 as a replacement for the current mechanism of 24-hour telephonic reporting to NCI. On June 30, 2003, the 24-Hour Notification via AdEERS became the required mechanism for submission of all 24-hour reports.

Commercial agents are those approved by the FDA for the specific indication(s) listed on the product label and obtained from a commercial source. On occasion, NCI or the industry sponsor may distribute commercial agents for a trial. Expedited reports pertaining to commercial agents should be submitted via the commercial agent track within AdEERS. Refer to the Adverse Events reporting section of the main protocol for guidance specific to the study.

Note: The combination of an investigational agent with a commercial agent under a CTEP IND is considered investigational

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