CATO Associate Clinical Trial Operations

Question 1

What is the primary objective of Phase I in clinical trials?

Accepted Answer

Evaluate safety and dosage in healthy volunteers

Answer

Test long-term efficacy

Answer

Determine side effects in large populations

Answer

Market the drug

Question 2

What is an essential document for participant protection in a clinical trial?

Accepted Answer

Informed consent form

Answer

Site monitoring log

Answer

Budget agreement

Answer

Protocol deviation memo

Question 3

Which role is responsible for monitoring site compliance and data integrity?

Accepted Answer

Clinical Research Associate (CRA)

Answer

Principal Investigator

Answer

Regulatory Affairs Manager

Answer

Data Entry Clerk

Question 4

Why are inclusion and exclusion criteria used in clinical trials?

Accepted Answer

To ensure consistent and safe study population

Answer

To increase enrollment numbers

Answer

To allow unrestricted participation

Answer

To determine funding needs

Question 5

What is the function of a Data Safety Monitoring Board (DSMB)?

Accepted Answer

Review data for safety concerns

Answer

Recruit participants

Answer

Market the study

Answer

Monitor site budgets

Question 6

What must occur before a clinical trial can begin?

Accepted Answer

IRB approval

Answer

Public announcement

Answer

Site selection

Answer

Contract with CRO