Exam 5

Question 1

ANDA is ?

Answer 1

Abbreviated New Drug Application

Question 2

Binder cover should have ?

Answer 2

Protocol Name
Protocol number

Question 3

The DOAL original form should be sent to the sponsor.

True or False

Answer 3

False

Question 4

The PI and site staff should use the same signature and initial when signing and initialing patient record

True or False

Answer 4

True

Question 5

The preparation and distribution of the IB is done by ?

Answer 5

Sponsor

Question 6

All submission to the IRB must be made using IRBNet

True or False

Answer 6

True

Question 7

SPOOS is

Answer 7

Significant Payment of Other Sorts

Question 8

DSMB Reports are submitted by ___to ____

Answer 8

PI …….IRB

Question 9

Exempt reviews are usually completed within______weeks from the submission date

Answer 9

2 weeks

Question 10

_______reviews are used in records of research within human subjects in which IRB is engaged but for which review and approval are not issued by the IRB ?

Answer 10

Administrative

Question 11

Investigator brochure should have all versions in chronological order

True or False

Answer 11

False

Question 12

DOAL is also called ??

Answer 12

Site Signature log

Question 13

CRADA is the FDA agreement for access to ?

Answer 13

ECG

Question 14

FDA’s preferred method of submission is via the FDA Electronic Submission Gateway

True or False

Answer 14

True