Clinical Trials 101 Jeopardy

Clinical Trial Phases

100

is the phase of study where the endpoint is mainly safety and efficacy

What is Phase 1?

200

is a post-marketing trial

What is Phase 4?

300

has a large group of participants and helps confirm efficacy

What is a Phase 3 trial?

400

is an early study that shows PK or toxicity data 

What is a pre-clinical trial?

500

is an expanded group of subjects and looks more at safety/efficay

What is a phase 2 trial?

Trial Documents

100

describes the plan for the research 

What is a study protocol?

200

is a document that all patients must sign

What is an informed consent form?

300

is called the statement of the investigator 

What is the FDA Form 1572?

400

is a document for MDs to sign that talks about financial interest

what is a financial disclosure form?

500

document that provides all clinical and non-clinical data about the investigational product

What is an Investigator's Brochure (IB)?

Study Start-up/Site Committees

100

are established to protect the safety and welfare of patients

What is an IRB/IEC?

200

is required to review human gene transfer clinical trials

What is an Institutional Biosafety Committee (IBC)?

300

may review the study for scientific merit

What is a Scientific Review Committee?

400

is a collection of documents and information sent to sites in study start-up

What is a regulatory packet?

500

is a document that must be negotiated and signed before a site can start enrolling patients

What is a Clinical Trial Agreement (CTA)?

Study Site Visits

100

is the type of visit done to evaluate the clinical site for a study

What is a Site Assessment Visit or Site Qualification Visit?

200

is the last time of visit done at the end of the study once all of the data is collected

What is a site close-out visit?

300

type of visit done prior to site activation to train the site

What is a Site Initiation or Site Activation Visit?

400

this type of visit is done during the course of the study to review the conduct of the study

What is a site monitoring visit or interim monitoring visit? 

500

is a meeting established to train sites 

What is an Investigator's Meeting?

Clinical Trial Personnel

100

is the person responsible at the site for conducting the study

What is the Principal Investigator (PI)?

200

the person who monitors the conduct of the trial and trains sites

Who is the Clinical Research Associate (CRA)?

300

is the company or person responsible for the clinical trial? 

Who is the sponsor?

400

is a company hired by a biotech or pharma company to conduct a clinical trial

What is a Contract Research Organization (CRO)?

500

is an individual who assists with the medical conduct of the study

Who is the Medical Monitor (MM)?