Exam 3

Question 1

Important study documents prior to visit are:

Answer 1

1-Draft protocol
2-study protocol
3-Non-Disclosure Confidentiality agreement

Question 2

Site selection involves the availability of suitable participants who meet the protocol entry criteria

True or False

Answer 2

True

Question 3

Phase 1 trial normally include ?

Answer 3

Dose ranging studies

Question 4

Investigators selection is based on ?

Answer 4

Education
Training
Experience

Question 5

Site Qualification Visit is the same as site initiation Visit ??

True or False

Answer 5

False

Question 6

The subject must be give a copy of the Informed Consent Form ?

True or False

Answer 6

True

Question 7

CRF is ?

Answer 7

Case Records Form

Question 8

The safety surveillance in phase 4 trials is designed to detect ?

Answer 8

Any rare or long term adverse effects
Safety in a much larger population

Question 9

Allocation method involving hospitals record is ???

Answer 9

Pseudo -Randomization

Question 10

When the sponsors conduct phase 1 and phase 2 studies then hires CRO to conduct larger studies, it is called

Answer 10

Strategic outsourcing

Question 11

Studies specifications are an essential element for proposal of :

Answer 11

Sponsor request
And
CRO

Question 12

During the closeout visit the site monitor should sign the visitor log

True or false

Answer 12

True

Question 13

Compliance issues should be reported to management only

True or False

Answer 13

False

Question 14

Ambulance facility should be available at the site for qualifications?

True or False

Answer 14

True

Question 15

CTMS is

Answer 15

Clinical Trial Management System