Expedited Reporting of Adverse Events to DAIDS

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• Expedited Reporting of Adverse Events to DAIDS
• Ellen Horton, RN, MS
• Office for Policy and Clinical Research
  Operations
• October 5, 2004

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• THE NEW EAE REPORTING FORM

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EAE REPORTING FORM

• The EAE reporting form can be printed from the
  RCC website and filled out by hand (pdf)
• In the future, the EAE reporting form will become
  interactive, and you will be guided to fill out
  only the pertinent sections and use drop-down
  boxes
• The EAE reporting form is a bridge to the
  future on-line reporting system (DAERS)

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EAE REPORTING FORM - 2

• EAE reporting form completion instructions will
• Be available on the RCC website
• Provide line-by-line guidance for completing
  the EAE reporting form

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Expedited Adverse Event (EAE) Reporting Form,
Page One
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Using the new EAE reporting form Page One

• Serves as a Cover Page if document is being Faxed
• BE SURE that your contact info is CORRECT AND
  LEGIBLE!!
• Be sure to indicate the TOTAL number of pages
  sent (including ALL attachments)
• For a Follow-up Report, only the pertinent pages
  need to be sent
• Non-network sites may not have site numbers at
  present

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Expedited Adverse Event (EAE) Reporting Form,
Page Two
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Using the new EAE reporting form Page Two

• Note Header Information must be on every page!
• ALL DATES must be in 04AUG2004 format
• Is this a SAE as defined by ICH Guidelines?
• Note Network Affiliation (or non-network)
• Supply subject information if known

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Expedited Adverse Event (EAE) Reporting Form,
Page Three
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Expedited Adverse Event (EAE) Reporting Form,
Page Four
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Using the new EAE reporting form Pages Three
and Four

• Information about the study agent(s) is captured
• Study Agent(s) must now be identified in the
  protocol
• Note that Section 3 is for ALL study agents
• Separate sections for therapeutics (4) and
  vaccines (5)

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Expedited Adverse Event (EAE) Reporting Form,
Page Five
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Using the new EAE reporting form Page Five

• Primary Adverse Event field should capture the
  ONE MAIN AE being reported
• Encourages clinician to try to select the term
  that BEST describes the event.

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Other clinically significant events associated
with Primary AE

• EXAMPLE Primary Event Grade 4 Pancreatitis
• Other Clinically Significant Events might
  include Grade 4 amylase, Grade 3 nausea
• These help describe the SEVERITY or COMPLICATIONS
  of the event. Dont list common signs/symptoms
  unless they add to reviewers understanding of
  the event.

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Expedited Adverse Event (EAE) Reporting Form,
Page Six
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Using the new EAE reporting form Page Six

• Do not list labs, diagnostic tests, and/or
  medications if copies of results or printed
  medications lists are attached!
• Concomitant Medications list any meds being
  taken AT ONSET of event
• AT ONSET may include meds taken in recent
  past, if relevant (in clinicians judgment)

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Expedited Adverse Event (EAE) Reporting Form,
Page Seven
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Using the new EAE reporting form Page Seven

• (Almost) LAST but definitely not LEAST!
• Narrative Summary is very important
• Dont restate information already captured
  elsewhere in the form

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Study Physician Signature (Page 7)

• If Study MD is not available to sign form, submit
  anyway! Signature page may be submitted within 3
  business days of original submission.

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Using the new EAE reporting form Supplemental
Form

• Supplemental Form for use with cyclic study
  agents such as IL-2

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Implementation of new manual and form is an
evolving process

• Becoming accustomed to this format will take time
• EAE Form CAN and SHOULD be submitted before all
  information is available. MINIMUM information
  Pages 12, identify study agent (Section 3), and
  Primary Event and relationship (Section 6)
• It is most important that pertinent adverse
  events ARE reported, not whether the form is
  completed perfectly!