Definitions
Acronyms
Reporting Timelines
Minor or Major
IRB Policies
100

This is a problem, event, or other act or omission that must be reported to the IRB.

Reportable Event

100

The abbreviation AE stands for this.

Adverse Event

100

Internal UPIRTSOs must be submitted within ____.

5 days

100

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.

100

This IRB policy is where you can find more information about Continuing Review.

Continuing Review of Research Policy

200

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

200

The abbreviation DSMP stands for this

Data Safety Monitoring Plan

200

Minor protocol deviations must be reported at _____.

Continuing Review

200

A blood draw was to take place at 11am. There was a 3 minute window. The 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

200

This Clinical Research Resources and Education page describes UPIRTSOs and Deviations and contains links to policies such as Submitting a Reportable Event to the IRB.

The Reportable Events page

300

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

300

The abbreviation UPIRTSO stands for this

Unanticipated Problem Involving Risk To Self or Others

300

Major protocol deviations must be reported within _____.

5 days

300
A CRC consented a patient to a study. The CRC signed today's date, 3/8/2021. The patient signed their birthdate, which was 3/9/2021.  All procedures occurred after the date signed by the patient.  This was discovered at the recent monitor visit.

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!

300

This Clinical Research Resources and Education page describes when an independent committee assembled to give an unbiased assessments of research might be needed and provides links to related guidelines and templates.

DSMB Reporting

400

Serious Adverse Events result in one of these 5 situations occurring.  

What is *Death * A Life-threatening incident *Inpatient hospitalization or prolongation of existing hospitalization *A persistent or significant incapacity of the ability to conduct normal life functions *A congenital anomaly/birth defect

400

The abbreviation SUSAR stands for this

Suspected unexpected serious adverse result

400

Changes to the investigator brochure must be reported within _____.

30 days

400

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.

400

In the policy library you can select this collection to find policies such as Informed Consent and the Research Subject or Submitting a Reportable Event 

Institutional Review Board

500

UPIRTSOs are major deviations or serious adverse events that meet these 3 criteria. 

*Unanticipated *Related *Serious

500

The abbreviation DSMB/C stands for this

Data Safety Monitoring Board or Committee 

500

Routine DSMB/DMC monitoring reports must be submitted at _____. 

Continuing review

500

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.

Major Deviation - the concomitant medications list made this person ineligible to participant in the study. This is a patient safety risk. 

500

In the policy library you can select this collection to find documents such as the Reportable Events Guideline and the Research Billing Invoicing Template (RBIT) Spreadsheet Procedure 

Research Study Coordination