Definitions
This is a problem, event, or other act or omission that must be reported to the IRB.
Reportable Event
The abbreviation AE stands for this.
Adverse Event
Internal UPIRTSOs must be submitted within ____.
5 days
A patient was consented to Study A by an individual not on the IRB with consenting rights who found the consent form printed in a folder in the nurses station.
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.
Major Deviation
The abbreviation DSMP stands for this
Data Safety Monitoring Plan
Minor protocol deviations must be reported at _____.
Continuing Review
A blood draw was to take place at 11am. There was a 3 minute window. He blood draw occurred at 11:04am. Was this likely a major or minor deviation?
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.
DSMB/C
The abbreviation UPIRTSO stands for this
Unanticipated Problem Involving Risk To Self or Others
Major protocol deviations must be reported within _____.
5 days
Minor Deviation - all research events occurred after the date signed by the patient. However, the consent note needs to be amended to correct the error. Also note, this would not happen if using e-consenting in PTrax!
Serious Adverse Events result in one of these 5 situations occurring.
What is *death * A life-threatening adverse event*Inpatient hospitalization or prolongation of existing hospitalization *A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions *A congenital anomaly/birth defect
The abbreviation SUSAR stands for this
Suspected Unexpected Serious Adverse Reaction
Changes to the investigator brochure that do not meet any of the 5 day reporting requirements must be reported within _____.
30 days
During an outpatient visit, a research patient should have 6 blood draws collected at 1 hour intervals. The RNs were able to draw 4 before the patient was admitted to the hospital to prepare for the next day's longer treatment schedule. The last blood draw was collected, but draw #5 was missed while moving the patient.
Minor deviation - most draws were collected including the immediate post dose draw and the last draw, enough to track the medication in the blood for patient safety.
UPIRTSOs are major deviations or serious adverse events that meet these 3 criteria.
*Unanticipated *Related *Serious
The abbreviation DSMB/C stands for this
Data Safety Monitoring Board or Committee
Routine DSMB/DMC monitoring reports must be submitted at _____.
Continuing review
Patient 001 was consented to the Study EEK for those who experience headaches. However, patients on daily blood thinners cannot be on this study and patient 001 had been on baby aspirin for 3 years per their medical history.