Site Initiated SAESafety Reporting

1
Site Initiated SAE/Safety Reporting

• Reporting Serious Adverse Events (SAE)
• AdEERS is the required reporting format for all
  SAEs
• All events that meet the criteria for an SAE must
  be reported regardless of grade or attribution
• SAE/Safety Reporting is separate, and in addition
  to Data Management AE reporting (on the CRF)
• Timeframes for submitting the report and the
  extent of reporting required are determined by
  the phase of the study, the expectedness and
  relationship of the event to protocol treatment
• SAEs must be reported to your IRB

2
SAE

• Serious AEs are defined by FDA and therefore
  seriousness (not
• severity) serves as a guide for defining
  regulatory reporting obligations
• for patient/subject safety. Seriousness is
  based on patient/event
• outcome or action criteria usually associated
  with events that pose a
• threat to a patients life or functioning. FDA
  Federal Regulations require
• IND sponsors to report serious AEs via expedited
  reporting.
• The two terms serious and severe are not
  interchangeable and their meanings should not be
  confused.

3
24 Hour AdEERS Notification Requirements

• Phase II III Studies All unexpected
  potentially related SAEs
• Phase I Studies All unexpected hospitalizations
  and all grade 4 and 5 SAEs regardless of
  relationship
• The timeframe for the complete AdEERS Report
  associated with any 24 Hour AdEERS Notifications
  is 5 days.
• All other SAEs that do not require the submission
  of a 24 Hour AdEERS Notification will be reported
  via AdEERS using the 10 day reporting timeline.

4
Timelines

• The time frame for submitting the required type
  of report will vary from FIVE to TEN CALENDAR
  DAYS according to the study phase, relationship
  and expectedness of the event.
• The day the event is reported is counted as day
  one.
• The reporting deadline is required to allow
  pharmaceutical sponsors to fulfill their external
  regulatory reporting obligations.

5
Table of Timelines
6
Proper Identification

• Proper identification of follow-up or amended
  reports,
• supporting source documentation and/or other
  information
• relevant to the SAE is imperative and must always
  include
• the RTOG study and case number
• Please use the RTOG Case Number as the Patient ID
  in the AdEERS System DO NOT ADD LEADING ZEROS

7
What type of other documentation must be
submitted with the AdEERS Report of an SAE?

• Only documentation noted by the reporter as being
  provided in the additional information section of
  AdEERS need be submitted initially
• If the pharmaceutical company requires further
  documentation or clarification, I will contact
  you via e-mail with their request
• The NCI may also contact you directly to request
  specific information or documentation

8
Dedicated SAE Fax Line

• 215-717-0990
• All necessary supporting source documentation
  relating to the SAE 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.

9
May 27, 2008
10
Guidance and/or Assistance with the AdEERS System

• It may be helpful to view the AdEERs Tutorial at
  the following link
• http//ctep.cancer.gov/reporting/AdEERS_CBT_v3/pat
  hways.htm
• Problems or issues with the AdEERS System for
  reporting AE/SAEs may also be referred to the
  following contacts
• For all medical and policy related issues, please
  contact the AdEERS Coordinators by email at
  AdEERSMD_at_tech-res.com ltmailtoAdEERSMD_at_tech-res.co
  mgt or telephone [phone].
• For all technical and training related issues
  please contact the NCI CTEP Help Desk by email at
  ncictephelp_at_ctep.nci.nih.gov ltmailtoncictephelp_at_c
  tep.nci.nih.govgt or telephone [phone].
• RTOG AdEERS Coordinator Stephen Dorian
  sdorian_at_phila.acr.org or 215-717-0857