The amount of time a site has to notify the sponsor/CRO of a SAE
What is 24 hours?
100
IRB
What is Institutional Review Board
100
The time frame the Regulatory packet should be completed and submitted.
What is 24-48 hours?
100
A slow heart rate
What is bradycardia?
100
Name one of the two types of audits that can occur.
What is Sponsor Audit/ FDA audit?
200
Any untoward medical occurrence experienced by a patient, whether or not considered drug related by the investigator.
What is an Adverse Event?
200
CCRC
What is Certified Clinical Research Coordinator
200
3 of the 9 documents in a Regulatory Packet.
What is dated protocol and amendments, Informed Consent template, 1572, Protocol Signature Page, IRB Submission Form, W-9, Financial Disclosure Forms, Delegation of Authority?
200
High Blood Pressure
What is Hypertension?
200
The turnaround time for monitor's queries.
What is the same day?
300
Two outcomes that classify a SAE
What is death, life-threatening illness or injury, hospitalization/prolongation of existing hospitalization, persistent/significant disability, congenital anomaly/birth defect?
300
ECRF
What is Electronic Case Report Form
300
The 1572 is a required contract between the ___ and the ____.
What is the PI and the FDA?
300
Chest pain
What is angina?
300
The frequency interim CRA visits occur_____ for a study?
What is throughout the trial?
400
The 3 entities you must notify upon receipt of notification of SAE.
What is the sponsor, IRB and monitor?
400
SMO
What is Site Management Organization
400
The two elements included on the Informed Consent Template.
What is PI/Site specific info and the stipend amount/how it will be paid?
400
Brusing
What is ecchymosis?
400
Benchmark's turnaround time for queries from data management.
What is 24-72 hours?
500
You are running a trial for patients with Congestive Heart Failure (CHF). In the Investigators Brochure are details that death may be an expected outcome of this investigational drug by exacerbating the patients CHF. If your patient expires from CHF this is considered a _____?
What is SAE
500
IVRS
What is Interactive Voice Response System
500
The entity who receives the original 1572.
Who is the Sponsor/CRO?
500
Gallbladder removal
What is cholecystectomy?
500
The amount of time when documents can be moved off site after study closeout and CD is received.