Exam 4

Question 1

PREA is ____?

Answer 1

Pediatric Research Equity Act

Question 2

Upon receiving the investigational drug what you need to verify?

Answer 2

Verify the content
Check the temperature monitor
Compare the quantity with the invoice

Question 3

IVRS and EDC have Protocol-specific integration touch point

True or false

Answer 3

True

Question 4

HIPAA stand for

Answer 4

Health Insurance portability and accountability act

Question 5

A variance from the protocol is:

Answer 5

Protocol deviation

Question 6

Any deviation not reported and later discovered by an audit is considered non-compliance with the FDA

True or false

Answer 6

True

Question 7

Records that documents the doses provided to the subject as specified by protocol are maintained by ?

Answer 7

Investigator

Question 8

Deliberante unblinding is done for patient safety

True or false

Answer 8

True

Question 9

Data handling is a part of article___?

Answer 9

Article 26

Question 10

The sources of Bias in a trial is/are:

Answer 10

Patient
Assessment team
Interpretation team

Question 11

Electronic data logging device are???

Answer 11

Accurate
Convenient

Question 12

Challenging and barrier that may prevent patients from enrolling in clinical trials are???

Answer 12

Consent
Historical mistrust
Healthcare Fatigue

Question 13

IRB cannot disapproved all research
Activities including proposed changes in previously approved human subjects

True or false

Answer 13

False

Question 14

An outdated version of ICF given to the subject is ___?

Answer 14

Non-compliance
Protocol deviation

Question 15

Finalizing budgets occurs at the site close out phase.
True or false

Answer 15

False