Jeopardy! Round

Trial by Fire! (Clinical Trials 101)

100

This clinical trial phase tests a new drug in a small group of people for the first time to evaluate safety.

What is Phase I? 

200

This is the document participants must sign before joining a trial.

What is Informed Consent?

300

What does the acronym IRB stand for?

What is Institutional Review Board?

400

This type of trial compares a new treatment to the current standard of care or already approved medication.

What is a randomized controlled trial (RCT)?

500

Name the three core principles of the Belmont Report.

What are respect for persons, beneficence, and justice?

GCP or Nah?

100

GCP ensures the rights, safety, and ______ of trial subjects are protected.

What is well-being?

200

This is the international guideline for GCP.

What is ICH E6 (R3)

300

True or False: GCP is legally enforceable in all countries.

What is False?

400

This key GCP document outlines trial procedures and objectives.

What is the protocol?

500

This critical document, required by GCP, must be signed and dated by both the PI and the sponsor or CRO before a trial can begin.

What is the CTA (Clinical Trial Agreement) (or: Investigator Agreement)

Rules, Regs and Red Tape(Regulations and Compliance)

100

This US agency oversees drug and device clinical trials.

What is the FDA?

200

HIPAA stands for this.

What is the Health Insurance Portability and Accountability Act?

300

What is the maximum report time for a serious adverse event?

What is 24 hours?

400

According to FDA regulations, this form must be submitted to the agency to notify them of a serious and unexpected adverse event during an investigational drug trial. 

What is an IND Safety Report?

500

Which regulation governs human subjects research in the U.S.?

What is 45 CFR part 46?

Protocol Patrol

100

This document lists every procedure a participant will undergo.

What is the Schedule of Events or Assessments? 

200

This is done to verify that the protocol is being followed by the site. 

What is monitoring?

300

A protocol must be reported when it affects ____ or ____? 

What is participant safety or data integrity? 

400

This type of visit prepares the site for study activation.

What is the SIV (site initiation visit)? 

500

During a monitoring visit, the CRA notices a pattern of late lab sample shipments. According to GCP, this type of issue should be documented and handled through what process?

What is a CAPA (Corrective and Preventive Action) Plan?

Who's Who??(BCT Staff Fun Facts)

100

This staff member was in voice lessons for 12 years and has a love for musical theatre.

Who is Kristy?