RTOG AESAE Reporting

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RTOG AE/SAE Reporting

• SAFETY REPORTING

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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

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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.

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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.

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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

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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.

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Table of Timelines
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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.