Orientation Guide

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Orientation Guide
Research and Development VAMC- Houston
Modified Date 01-19-2006
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Adverse Events

• It is important to stress reporting of any
  adverse events.
• With permission of our friends and colleagues at
  Baylor we have included the following
  presentation

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What is An Adverse Event

• An unanticipated problem that involves risks or
  potential harm to study subjects.
• Any untoward (serious and unexpected) medical
  occurrence presenting during treatment or
  administration with a pharmaceutical product or
  device that may or may not have a casual
  relationship with the treatment.

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Types of Adverse Events
Serious AEs Include death, an acute life
threatening event (ALTE), a permanently disabling
experience, hospitalization that is precipitated
by or prolonged by an adverse experience, a
congenital anomaly, the development of cancer, a
drug overdose, or in the physicians judgment, an
experience that qualifies as such. Unexpected
AEs Are defined as any adverse events that are
not identified in nature, severity, or frequency
in the investigators brochure or described in
the research protocol.
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What and When to Report
All serious events that occur while a subject is
enrolled in a clinical research study, or within
30 days of completing a study at BCM or its
affiliated hospitals must be reported to the IRB.
SERIOUS AES WHETHER EXPECTED OR UNEXPECTED,
MUST BE REPORTED EVEN IF THERE IS NO PERCEIVED
CONNECTION TO THE RESEARCH.
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What and When to Report

• All unexpected deaths and ALTEs, including grade
  4 toxicities, whether related or unrelated to the
  drug or device, must be reported verbally, by fax
  or email within 48-72 hours. A report must be
  submitted via BRAIN within 10 working days.
• All expected serious AEs, including deaths and
  ALTEs must be reported in BRAIN within the same
  year of occurrence.

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What and When to Report

• In the absence of chronic underlying disease,
  the occurrence of a death or ALTE in an otherwise
  healthy individual, whether related to the
  research or not, should be reported (email)
  promptly within 48-72 hours by the PI to the IRB.
  A report must be submitted via BRAIN within 10
  days.
• All non-serious AEs may be reported to the IRB
  at the PIs discretion.

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What and When to Report
All IND reports that the Sponsor has requested
to be submitted to the IRB can be sent on a
disk/CD or as a hard copy as well as submitting
into BRAIN only listing the IND report numbers in
Description.
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Who Reports AEs and SAEs

• Although Coordinators/Administrative staff may
  report AEs SAEs, the PI is ultimately
  responsible for the reporting of events that
  occur at BCM as well as the affiliated hospitals.
• All AEs and SAEs must be reported to the BCM
  IRB _at_ 713.798.6990 (fax) or irb_at_bcm.tmc.edu.
• After reporting AEs and/or SAEs, they must be
  entered into BRAIN and submitted to the Office of
  Research for review _at_VAAE_at_bcm.tmc.edu

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Other Documentation to Report

• PI should send any supporting documentation that
  may be beneficial for the IRB to review.
• Progress reports are required if the
  complications of the AE have not been resolved at
  the time the original report was submitted.
• For multi-center trials, the PI should forward
  the DSMB summary report of AEs to the IRB
  whenever a review takes place.

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IRB Response to AEs

• Serious AEs BCM
• Are promptly reviewed (through BRAIN) by an IRB
  Chair or Vice-Chair.
• After review, the Chair or Vice-chair will
  approve the AE, or request that modifications be
  made to the protocol and/or the consent form.
  The Chair or Vice-chair may request that
  enrollment be stopped until a proper plan is
  developed.
• All modifications requested will be returned to
  the PI via BRAIN.

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IRB response to AEs cont.

• Serious AEs Non-BCM
• Are acknowledged by BRAIN within 24 hours of
  receipt.
• Non-Serious AEs Non-BCM
• Are acknowledged by BRAIN within 24 hours of
  receipt.

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Emergency Unexpected AEs

• If a situation arises in which an unexpected,
  related SAE occurs and requires an emergent
  change in the protocol, the following should
  occur
• The PI contacts the IRB to inform of SAE.
• One of the Chairs communicates with the PI
  regarding the steps which need to be followed.
• Enrollment must stop immediately.
• PI must submit SAE report via BRAIN within 48
  hours.

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Emergency Unexpected AEs

• PI must also submit a written report to the IRB
  Executive Committee providing a plan to ensure
  safety of subjects.
• This plan must be reviewed by Dept. Chair for
  adequacy before submission to the IRB.
• Once submitted to IRB plan is reviewed and PI
  will receive instructions on how to proceed.

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Office of Research/IRB Staff Contact
Brady Duke bduke_at_bcm.tmc.edu 713-798-7213 Bridge
t Fagbeyiro fagbeyir_at_bcm.tmc.edu
713-798-5308 Charles Imo cimo_at_bcm.tmc.edu 713-79
8-7692 Miguel Aguirre
aguirre_at_bcm.tmc.edu 713-798-2011
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Reporting Adverse Events to The Research and
Development Office
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Reporting AEs to RD
Coordinator or PI
Deaths/ Serious AEs Within 24 hours 1.
Report in BRAIN 2. Call Baylor IRB 713-798-6970
or Email _at_ IRB_at_bcm.tmc.edu if brain is not
working 3. Call VA RD- for ALL DEATHS -Marilyn
Crosby RN Phone [phone] or Joyce McDaniel
phone [phone] with protocol number and
Adverse Event number/patient initial and last
four numbers of SSN Email all other Adverse
Events To VAAE_at_bcm.tmc.edu 4. Write a note in
CPRS
Other Adverse Events 1. Report in Brain within 10
days (med watch, have to be reported within one
year)
Adverse Event Death or any medical occurrence
that is considered unfavorable or unintended (if
in doubt, report it).