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Clinical Trial Safety Assessment and Reporting

Jenny Powell

Introduction and Purpose

Introduction and Purpose

  • Safety assessment is a way to categorize and report a negative medical health consequence

  • We do this to accurately and promptly ensure the safety of each patient

Definitions and Criteria

  • How do we categorize and define safety assessments to be uniform across research sites?

Definitions and Criteria

Definitions

  • Adverse Event

  • Serious Adverse Event

  • Unanticipated adverse device effect

Adverse Event

  • Any negative medical occurence in a clinical trial that may or may not be related to treatment received

  • A suspected adverse reaction means that there is a reasonable possibility that the trial drug is responsible for the event

Adverse Event

Serious Adverse Event

Serious Adverse Event

  • An adverse event is considered "serious" if it results in:
  • Death
  • A life-threatening event
  • Inpatient hospitalization
  • Persistent disruption of normal life function
  • Birth defects
  • Other serious important medical events

Unanticipated adverse device effect

  • Any serious heath event that can effect the safety of a participant that is associated with a research medical device

Unanticipated adverse device effect

Evaluation Criteria

Evaluation

Criteria

  • Studies need categorization to evaluate safety events that are relevant and uniform to oversight agencies like the IRB.

Severity

  • Is determined after the designation of an AE

  • It refers to the intensity of the event as well as the long-term health ramifications to the participant

  • Normally evaluated on a scale ranging from mild to death

Severity

Attribution (Relatedness)

  • Refers to the relationship that that event may have to the research intervention

  • Investigator determination of whether there is a causal relationship between the AE and treatment

  • Normally evaluated on a scale from unrelated to definitely related

Attribution (Relatedness)

Expectedness

  • Refers to whether the AE was anticipated according to the current understanding of the research intervention or the natural progession of the pathology being studied

Expectedness

Prompt Reporting

  • Due to the important nature of safety assessment is is pivotal to have fast and accurate reporting so that oversight agencies can determine if the event reaches certain criteria.

Prompt Reporting

Collection and Evaluation

  • What is the best way to collect information about the safety event?
  • Once it is identified, what are the proper steps for evaluation?

Collection and Evaluation

Collection

  • What steps should be done before the study begins so I know what to collect?

  • AE source documentation over time

Review

  • At the beginning of the study and periodically throughout maintain familiarity with all the study material in regards to AEs (protocol is your best friend).

  • Make sure you are aware of the individual reporting window

  • Before giving any treatment, make sure that the I/E has been thoroughly reviewed, by research team and PI, and you are familiar with their medical history

Proper

Review

Maintenance of Source

  • Continue to collect source through their time in the study and document thoroughly, such as:
  • Diaries and questionnaires
  • Clinical observations
  • Abnormal test results
  • Reports from non-study related encounters like ED visits

Maintenance

of Source

Evaluation

Evaluation

  • Severity, attribution, expectedness, and seriousness should be assess by the PI (coordinators do not make this evaluation)

  • Make sure you are aware of your reviewing IRB policy and what scales your IRB is using

  • If your study involves a drug, make sure you are aware of dose-limiting toxicity (DLT) to ensure treatment is safe prior to moving on to the next dose

Documentation and Reporting

  • How can I concisely log each AE has they occur?
  • How do I make sure that the the correct parties know about the AE?

Documentation and Reporting

Documentation

  • For each participant, an adverse event log should be maintained in the regulatory portion of your study

  • You should also collect source to incorporated into study binders to better document the AE

  • Make sure you are maintaining prompt review by the coordinator and PI (make sure logs are signed and dated)

Documentation

Reporting

  • Methods of reporting

  • IRB Requirements

  • FDA Requirements

Reporting

Methods of Reporting

  • The method of reporting will vary by study and is generally outlined in the protocol. Common methods are paper-based forms or an EDC.

  • Make sure you are aware of what IRB reporting mechanism is being used

  • Time-reporting windows will vary based seriousness.
  • You have a 24 hour window to report SAEs
  • If a PI is unavailable during this time a sub-PI can be used

Methods of Reporting

IRB Requirements

  • The University of Utah IRB requires AE reporting if the following criteria are met:

  • Unexpected
  • Definitely or probably related to research
  • Places participant at great harm

IRB

Requirements

FDA Requirements

FDA

Requirements

  • You must promptly report to FDA if it meets the following criteria:
  • Serious
  • Unexpected
  • Related

  • Fatal or life-threatening events must be reported with 7 days of learning about it

  • All other events that still meet the above criteria but are not life threatening must be reported in 15 days
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