CTA Regulatory Guidelines and Compliance 1

Question 1

Which international guideline governs Good Clinical Practice (GCP)?

Accepted Answer

ICH E6(R2)

Answer

FDA Part 11

Answer

ISO 9001

Answer

HIPAA

Question 2

What is the main purpose of FDA Form 1572?

Accepted Answer

To document investigator responsibilities

Answer

To request IRB approval

Answer

To collect patient data

Answer

To enroll new trial sites

Question 3

What does 21 CFR Part 11 regulate?

Accepted Answer

Electronic records and signatures

Answer

Drug labeling

Answer

Clinical trial protocols

Answer

IRB review procedures

Question 4

Which regulatory body oversees drug approval in the United States?

Accepted Answer

FDA

Answer

EMA

Answer

WHO

Answer

CDC

Question 5

What is a sponsor's key regulatory responsibility in a clinical trial?

Accepted Answer

Ensure protocol compliance and data reporting

Answer

Recruit study subjects

Answer

Administer treatments

Answer

Monitor site staff salaries

Question 6

What is the purpose of an audit in clinical research?

Accepted Answer

To verify compliance and data accuracy

Answer

To discipline non-compliant staff

Answer

To increase participant numbers

Answer

To replace site monitors

Question 7

Which document must be submitted to the FDA before human trials can begin?

Accepted Answer

IND

Answer

CSR

Answer

IB

Answer

NDA

Question 8

What is a protocol deviation?

Accepted Answer

Any departure from the approved protocol

Answer

Addition of a new study site

Answer

Updating the informed consent

Answer

Early termination of the trial

Question 9

Why must adverse events be reported to regulatory authorities?

Accepted Answer

To maintain FDA approval

Answer

To delay study timelines

Answer

To allow more participant enrollment

Answer

To reduce monitoring visits