1	RTOG AE/SAE Reporting SAFETY REPORTING
2	NCI Guidelines for SAE Reporting State: … Any medical event equivalent to CTC Grade 3, 4, 5 which precipitated hospitalization (or prolongation of existing hospitalization) must be reported regardless of requirements for Phase of study, expected or unexpected and attribution. CTEP Home Page: http://ctep.info.nih.gov NCI GUIDELINES: EXPEDITED ADVERSE EVENT REPORTING REQUIREMENTS FOR NCI INVESTIGATIONAL AGENTS Section 3, Table C1 January 2001
3	CTEP SAE Definition Any adverse drug experience occurring at any dose that results in any of the following outcomes: Death A life-threatening adverse drug experience Inpatient hospitalization or prolongation of existing hospitalization A persistent or significant disability/incapacity; A congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered an SAE drug experience, when, based upon medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in the definition.
4	SAE/Safety Reporting RTOG SAE Safety Reporting Requirements All SAEs that fall under any one of the categories outlined in the previous SAE definition must be reported via telephone to RTOG Data Management 215-717-2762 within 24 hours of discovery of the event. The Data Manager taking the call will inform the caller which type of report (5 or 10 day AdEERS) is required for the event. The required report must be submitted electronically within the required timeframe from the initial phone report to allow RTOG to comply with the reporting requirements of pharmaceutical sponsors. All supporting source documentation must be faxed to the RTOG dedicated SAE fax line [215-717-0990] as soon as available. In addition, AML/MDS diagnosis requires a 30 day timeframe for reporting using Secondary AML/MDS Form available on NCI Website SAE reporting is safety related separate from and in addition to data management toxicity reporting requirements.
5	Proper Identification Proper identification of follow-up or amended reports, supporting source documentation and/or other relevant information is imperative and must always include RTOG study and case number
6	Dedicated SAE Fax Line 215-717-0990 All necessary supporting source documentation noted as being supplied in the Additional Information Section of the AdEERS Report should be properly labeled with the RTOG Study and Case Number as well as the date of the corresponding event and provided within the allotted timeframe or as soon as it becomes available via the RTOG SAE Dedicated Fax Line at 215-717-0990.
7	Table of Timelines
8	Timelines The time frame for submitting the required type of report will vary from FIVE to TEN CALENDAR DAYS according to the expectedness and relationship of the event. The day the event is called in to RTOG HQ is counted as day 1. The reporting deadline is required to allow pharmaceutical sponsors to fulfill their external regulatory reporting obligations.