Definitions
This is a problem, event, or other act or omission that must be reported to the IRB.
What is a Reportable Event?
The abbreviation AE stands for this.
What is Adverse Event?
Internal UPIRTSOs must be submitted to the IRB within this timeframe
What is 5 days?
A patient was consented to Study A by an individual not on the IRB.
What is Major Deviation - a consenting individual must be on the IRB with consent rights.
This is a departure from the protocol that affects the rights and welfare of subjects and others, increases risks, decreases potential benefits, compromises the integrity research, or represents willful misconduct.
What is a Major Deviation?
The abbreviation DSMP stands for this
What is Data Safety Monitoring Plan?
Minor protocol deviations must be reported to the IRB at this time.
What is Continuing Review?
A research blood draw was to take place within 5 minutes of infusion but took place 10 minutes after infusion
What is Minor Deviation - unlikely to have caused any harm to the patient or risk to integrity of the study
This is an independent committee who offers an unbiased assessment of a study's progress, including whether it should be continued as is, modified, or discontinued.
What is a DSMB/C?
The abbreviation PHI stands for this
What is Protected Health Information?
Major protocol deviations must be reported to the IRB within this timeframe
What is 5 days?
An SAE report was submitted to sponsor with the subject's MRN
What is a Major Deviation - unapproved PHI disclosure is considered a major deviation & reportable to IRB within 5 days
Ongoing Medical History can also be referred to as this type of event
What is Baseline Adverse Event?
The abbreviation SUSAR stands for this
What is Suspected Unexpected Serious Adverse Reaction?
Changes to the investigator brochure that do not meet any of the 5 day reporting requirements must be reported to the IRB within this timeframe
What is 30 days?
A patient was enrolled to your study who did not meet eligibility criteria
What is a Major deviation - enrolling ineligible patients may put the research participant at risk while yielding invalid data.
UPIRTSOs are major deviations or serious adverse events that meet these 3 criteria.
What is *Unanticipated *Related *Serious
The abbreviation UPIRTSO stands for this
What is Unanticipated Problem Involving Risk To Self or Others?
Routine DSMB/DMC monitoring reports must be submitted at this time.
What is Continuing review?
Study staff not on the delegation but trained and on the IRB consented a patient
What is a Minor Deviation - as staff received training and was approved on the IRB, deviation is considered minor