Panther study
He is the principal investigator for the entire study?
Who is Dr. Dan George?
National Clinical Trial Day
What is May 20?
This is the amount of time an investigator has to report a serious adverse event (SAE) to the sponsor.
Answer Choices: 7 calendar days, 15 calendar days, Immediately, Within 24 hours
What is 24 hours?
This document outlines responsibilities that the PI assigns to research team members and the dates of involvement
What is the delegation of authority log?
This person is responsible for designing and writing the protocol. Answer Choices: Sponsor, Investigator, Coordinator, CRO
Who is the sponsor?
Name the primary endpoint for Panther.
What is radiographic progression free survival?
name the actor who does the background vocals of the cowboy doll, Woody, in Toy Story.
Who is Tom Hanks?
On Dec. 6th, a site learns of a subject death that occurred five days earlier on Dec. 1st. The sponsor receives word of the subject death from the site that same day (Dec. 6th). The sponsor knows they need to report the SAE to the Regulatory Authorities (FDA) no later than this date. Answer Choices: Dec. 7th, Dec. 8th, Dec. 13th, Dec. 21st
What is Dec. 13th?
A CRA is preparing to conduct a pre-study visit with a site. The CRA knows this document will be the best resource for answering questions the investigator may have about the rationale for the investigational product (IP), the dose and regimen, the risk/benefit ratio, and the pharmacology and toxicology data of the IP? Answer Choices: Protocol, Investigator Brochure, Patient Information Pamphlet, Informed Consent Form
What is the Investigator's Brochure (IB)?
Set of 10 research ethic principles for human experiments as a result of World War II?
What is the Nuremburg code?
Name 3 side effects of abiraterone.
What are: hypertension, fatigue, swelling of your legs/feet, joint swelling or pain, hypokalemia, elevated AST/ALT.
He physically wrote the Declaration of Independence.
Who was Thomas Jefferson?
The document was drafted by a committee made up of John Adams, Benjamin Franklin, Thomas Jefferson, Roger Sherman, and Robert Livingston.
Name two other states participating on this study?
What is North Carolina, Louisiana, Michigan, Virginia, South Carolina?
As a research coordinator, you would most likely enroll oncology patients into a first-in-humans trial during this study phase. Answer Choices: Phase I, Phase II, Phase III, Phase IV
What is Phase I?
This group determines a study is no longer safe for subjects to continue based on a scheduled review determined in the protocol of the efficacy and safety data and informs the sponsor to terminate the trial. Answer Choices: CRO, IDMC/DSMB, IRB
What is the Data Safety and Monitoring Board (DSMB) OR the Independent Data Monitoring Committee (IDMC)?
Name three side effects of apalutamide.
What are fatigue, hypertension, falls, elevated TSH, RASH?
This soft drink was originated in North Carolina
What is Pepsi Cola?
The sponsor needs these 4 minimum items in order to begin processing an SAE.
What are:
1)name of the site reporting the SAE
2)the product it concerns
3)the patient who is affected
4)the actual event (SAE)
Length of time subject will be followed for survival.
What is until death, lost to follow up or study is closed?
The minimum number of Institutional Review Board (IRB) members.
What is 5?
This document contains information on the study procedures and schedule, how compliance will be measured, the statistical methods employed in the trial, and the timing of any planned interim analyses. Answer Choices: Investigator's Brochure, Protocol, Confidentiality Agreement, Case Report Form
What is the Protocol?
The Beatles made their first famous live US television appearance on this show.
What is the Ed Sullivan show (1963)?
45 CFR Part 46
What is the code of federal regulations that governs the protection of human subjects?
Drug or treatment given to large groups of people (1,000-3,000) to confirm effectiveness, monitor side effects, compare to standard or similar treatments and collect information that will allow the drug or treatment to be used safely. Possible answers: Phase I, Phase II, Phase III, Phase IV
What is a Phase III clinical trial?
Provides the grades (1-5) for adverse events
What is the CTCAE (Common Terminology Criteria for Adverse Events) Version 5 (current)?