Abbreviations
Medical History
Processes
Subject Interaction
Reg
100

IRB

What is the Institutional Review Board?

100

What is TID?

Three times a day

100
Timeframe to report an SAE

What is 24hrs?

100

The documents mandatory to enroll in a clinical research study?

What is ICF and IAF?

100

What does ISF stand for?

Investigator Site File

200
CRF
What is Case Report Form?
200

Medical term for gall stone removal

cholecystectomy

200

What is the order of site visits

Pre-study selection visit

SIV

IMVs

COV

200
In a double blind clinical trial, which parties are blinded?

Participant and clinical staff

200

Which reg documents addresses conflict of interest? 

FDF

300
IND
What is Investigational New Drug?
300

Partial Hysterectomy removes what organs?

Uterus (ovaries and cervix remain)

300

What is necessary to screen first patient?

IRB approval, Essential Reg Documents, Greenlight Letter (Supplies)

300

To begin a clinical research study, it's mandatory to get approval from who?

Ethics committee (IRB) and sponsor 
300

What document must be submitted on a yearly basis for each study? 

Continuing Review

400
HIPAA
What is the Health Insurance Portability and Accountability Act?
400

WOCBP

What is a women of childbearing potential?

400

Blood tube for HBA1c

Purple top tube

400
What constitutes a patient as LTFU?

three different attempts at contact, at three different times and a certified letter.

400

Name 4 essential reg documents

FDF,  FDA 1572, CV, Medical License, GCP, PSP, IB AOR
500
DSMB
What is the Data and Safety Monitoring Board?
500

What does systolic pressure measure?

Pressure in arteries when heart contracts

500

Order of Draw

Blue

Gold / Red

Green

Lavender / Purple

Gray

500

Finish the phrase: "If not documented,....

"It didn't happen"

500

What are the 3 main IRBs CHR works with?

Advarra, WCG, Sterling

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