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Adverse Events and Serious Adverse Events. Office of Research Education and Regulatory Management. Objectives. Recognize Adverse Events and serious adverse events Review FDA inspection findings related to adverse events Review regulations related to adverse events

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adverse events and serious adverse events

Adverse Events and Serious Adverse Events

Office of Research Education and Regulatory Management

  • Recognize Adverse Events and serious adverse events
  • Review FDA inspection findings related to adverse events
  • Review regulations related to adverse events
  • Discuss recording and reporting of adverse events
  • Discuss auditing of adverse events
  • Demonstrate audit of adverse events
fda inspection
FDA Inspection
  • “Failure to prepare and submit complete and accurate and timely reports of unanticipated adverse device effects”
adverse events
Adverse Events
  • Any adverse event associated with the use of a drug in humans, whether or not considered related.
    • 21CFR 314.80
  • Any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment
    • ICH E6
adverse event
Adverse Event
  • NCI
    • An unexpected medical problem that occurs during treatment with a drug or other therapy.
    • Adverse events do not have to be a caused by the drug or therapy
serious adverse event
Serious Adverse Event











Medically Significant

Life Threatening

expected vs unexpected
Expected Vs. Unexpected
  • Expected
    • Known to Occur and is Listed in the Investigational Brochure, Informed Consent, or General Investigational Plan
  • Unexpected
    • Not listed in Investigational Brochure, Informed Consent, or General Investigational Plan
    • Also not listed in a drug package insert
  • Know which adverse events the protocol requires to be captured
source documentation
Source Documentation
  • Source Documentation of adverse events include documentation in the medical records of:
    • Event
    • Date it occurred
    • Grade as determined by CTCAE
    • Expected or Unexpected
    • Attribution as assigned by PI
    • Date resolved
    • Treatment patient received specifically related to event
sample adverse event recording form
Sample Adverse Event Recording Form
  • See template behind this presentation
attribution causality
Attribution (Causality)
  • The attribution (relationship or causality or drug related assessment) must be determined
  • A determination made by a clinical investigator that describes the relationship or association of the study product with an adverse experience
  • This determination must be recorded both in the medical record as well as in the case report form.
  • What should the investigator consider prior to assigning attribution?
    • Individual medical history
    • Known effects of concomitant medications
  • Definite – Clearly related to study agent
  • Probable – Likely related to study agent
  • Possible – May be related to study agent
  • Unlikely – Doubtfully related to study agent
  • Unrelated – Clearly not related to study agent
how to capture adverse events
How to Capture Adverse Events?
  • Split or Lumped
    • Fever, Diarrhea, and Vomiting (Viral Gastroenteritis)
    • Cough, Sniffles, Sore throat (Flu)
how to capture adverse events18
How to Capture Adverse Events?
  • Problems with similar terms
    • Rash or Dermatitis
    • Wheezing, reactive airway disease, congestion, cold, , asthma
documenting resolution dates
Documenting Resolution Dates
  • Challenge
    • Does the patient remember when their adverse event resolved?
    • Do you call the patient? Or wait till the next visit?
patient toxicity diary
Patient Toxicity Diary
  • Diaries where patients capture toxicities between their follow up appointments
patient toxicity diaries
Patient Toxicity Diaries
  • Patient writes down constipation because he did not have a bowel movement one day
    • Research nurse captures constipation without assessing further
    • Physician copies the research nurse’s note and also dictates constipation
  • Did anyone ask about the constipation?
    • According to CTC V3, constipation is grade 1 only if there is occasional or intermittent symptoms; occasional use of stool softeners, laxatives, dietary modification, or enema
patient adverse event diaries
Patient Adverse Event Diaries



Time consuming

Patient non-compliance

Patient self diagnosis or interpretation

Complicated Instructions

  • Allows capturing information on a daily basis while patient is away from clinic
  • A communication tool for patient returns to clinic
  • Useful in capturing onset and resolution dates of adverse events
question to ask
Question to ask
  • When should site staff begin collecting adverse event information?
question to ask24
Question to ask
  • How long should one collect adverse events after the subject completes study treatment?
reporting serious events
Reporting Serious Events
  • An investigator must promptly report to the sponsor any adverse effect that may reasonably be regarded as caused by or probably caused by the drug. If the adverse effect is alarming, the investigator shall report the adverse effect immediately.
    • 21CFR312.64
reporting criteria
Reporting Criteria
  • Routine Reporting
    • Know which events can be reported at interim analysis or annual reviews
  • Expedited Reporting
    • Know which events require immediate reporting
reporting criteria28
Reporting Criteria
  • Know which type of expedited reports each regulatory body requires
    • FDA
    • Sponsor
    • Co-Sponsor
    • MD Anderson
    • NCI
    • Collaborative Groups
issues in reporting
Issues in reporting
  • Primary events
    • Example
      • Patient admitted with Congestive Heart Failure
      • Subsequently develops: Pulmonary Edema and Cardiogenic Shock
consequences of improper reporting
Consequences of Improper Reporting
  • Protocol Violations
  • IRB will close protocol
  • FDA Hold
  • Sponsor Hold
  • Research Privileges Revoked
  • Patient Safety
auditing check points
Auditing Check Points
  • How are AEs being recorded in the medical record?
  • Does documentation include grade, onset, resolution, and attribution?
auditing check points33
Auditing Check Points
  • Were all toxicities included?
  • Was the proper CTCAE version used for the protocol?
  • Were the toxicities graded appropriately?
auditing check points34
Auditing Check Points
  • Was the event a dose limiting toxicity?
  • Should the dose have been reduced?
  • If so, did the research team realize it as such and identify it correctly?
  • Are adverse events appropriately reported within the time periods required by regulations, sponsor, and IRB policies?
we have reviewed
We have reviewed……….
  • Recognizing adverse events and serious adverse events
  • Inspections and findings related to adverse events
  • Regulations related to adverse events
  • Recording and reporting of adverse events
  • Auditing of adverse events