1) What is the first step in the informed consent process?

A)Patient Survey

B) Written informed consent

C)Recruitment

D) Initial consent

2)Phase ___ studies are most often conducted in patient volunteers who have diagnosed with the disease or condition the drug is intended to treat as opposed to normal healthy volunteers.

I

II

III

IV

3) Which of the following is NOT a Clinical Trial Service Provider?

A)Site Management Organizations (SMOs)

B)Clinical Research Organizations (CROs)

C)Study Monitors

D)Electronic data capture (EDC)

4)When an investigator or investigative site is presented with a clinical trial opportunity, the proposed study must be fully evaluated from the:

A)medical perspective

B) scientific merit

C)site capability perspective

5)__________ has been the "middlemen" of the data management process.

A) Contract Research Orgaqnization (CRO)

B) Case report forms (CRFs)

C) Clinical Investigators

D) None of the above

6) When an FDA Inspector arrives on site, the staff should perform the following procedures except:

A) Verify the inspector's credentials.

B) Record the inspector's badge number.

C) Review the financial agreement between the inspector and sponsor.

D) Obtain a copy of the 482

7)Anindividual who is a "no show" should be given no more than ______ opportunities before they are taken off the participant list.

1

2

3

4

8)Which of the following research participants are mostly likely to have the study take place at their home?

A) Hopeless

B) High Maintenance

C) Non-compliant

D) Information Seeker

9)It'scommon to forinvestigators to add and additional ______% when using the services of other medical providers.

5

10

20

25

10)