IRB Basics
The IRB exists to protect this group of people.
What are human subjects?
This is the first step before enrolling patients.
What is site initiation/IRB approval?
A fever in a neutropenic child qualifies as this.
What is a Serious Adverse Event (SAE)?
This is the international standard for conducting clinical trials.
What is ICH-GCP?
A nurse orders pizza for a neutropenic kid. The violation?
What is breaking neutropenic precautions?
Children require this in addition to parental consent
What is assent?
his person is ultimately responsible for the trial.
Who is the Principal Investigator?
A nosebleed that resolves on its own would be classified as this.
What is an Adverse Event (AE)?
If it’s not documented, this phrase applies.
What is “It didn’t happen”?
A CRC posts a patient’s photo with #ChemoLife on Instagram. The violation?
What is HIPAA/privacy breach?
(Crazy Scenario): Grandma signs the consent form, but has no legal authority. The IRB shuts down your site. This was the mistake.
What is obtaining consent from someone without legal guardianship?
In pediatrics, this must be checked before every chemo infusion.
What are eligibility/lab requirements?
This group must be notified within 24 hours of a SAE.
Who is the sponsor?
This ensures chemo drugs are stored, dispensed, and tracked properly
What is drug accountability?
ab samples left on the dashboard in August sun result in dust. The mistake?
What is improper sample handling/storage?
Failing to report this to the IRB could shut down your study.
What is a protocol deviation?
(Crazy Scenario): A child is enrolled on an adult lung cancer study. This step was missed.
What is verifying the protocol and eligibility criteria?
(Crazy Scenario): A toddler floods the isolation room with an explosive diaper. The team debates whether to file this.
What is an AE/Facilities report mix-up?
(Crazy Scenario): Oral chemo is dispensed in a Tylenol bottle and given to siblings. This principle was violated.
What is proper labeling and accountability?
(Crazy Scenario): You enroll a patient missing the required baseline labs. The outcome?
What is a protocol deviation (and possible removal from study)?
his federal regulation governs human subject research.
What is the Common Rule (45 CFR 46)?
This phrase describes the last patient’s final study visit.
What is “Last Patient Last Visit”?
An unanticipated problem that increases risk to subjects is called this.
What is a reportable event (or UPIRTSO – unanticipated problem involving risk to subjects or others)?
This document is the “blueprint” of the clinical trial.
What is the protocol?
The ultimate reason for GCP, IRB, and reporting requirements.
What is to protect patient safety and data integrity?