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Site Initiated SAESafety Reporting

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AdEERS is the required reporting format for all SAEs ... outcome or action criteria usually associated with events that pose a ... – PowerPoint PPT presentation

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Title: 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 (301) 897-7497.
  • 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 (301)840-8202.
  • RTOG AdEERS Coordinator Stephen Dorian
    sdorian_at_phila.acr.org or 215-717-0857
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