Exam 1

Question 1

Internacional quality standards provided by ICH is

1-GLP
2-GCP
3-GCLP

Answer 1

GCP

Question 2

When dealing with E signature, a password policy should be implemented to change password.

True or False

Answer 2

True

Question 3

Internal Adverse Events that are unexpected, fatal or life threatening and related or possibly related to the research to the research intervention must be reported within

Answer 3

24 hr

Question 4

21CFR Part 11 deals with Electronic records and Electronic signature

True or False

Answer 4

True

Question 5

Any Serious Adverse effects on health or safety or any life threatening problem or death caused by or associated with a device, if not identified in the device brochure, protocol or consent form is

Answer 5

Unanticipated Adverse Device Effect

Question 6

The father’s consent is needed even if the pregnancy resulted from rape or incest.
True or False

Answer 6

False

Question 7

The probability and magnitude of physical and physiological harm in a research involving prisoners is

1-Maximal Risk
2-No risk
3-Minimal Risk
4-None of the about

Answer 7

Minimal Risk

Question 8

CFR21 Part 11 is

Answer 8

Technical and Procedural

Question 9

The need of record retention should be informed to the investigators/institution in

Answer 9

Written form

Question 10

A formal process that ensures consistent operation of system as per the regulatory requirement to ensure and manage information is called.
1-Computer System Confidentiality
2-Computer System Validation
3-Computer Security Assurances
4-Computer System Accuracy

Answer 10

Computer system Validation

Question 11

The possibility of unforeseeable risks must be taken into consideration when involving pregnant women and fetuses
True or False

Answer 11

True

Question 12

The participant identity should be concealed as

1-Writen
2-Verbal
3-Both 1 and 2

Answer 12

Written and Verbal

Question 13

The consent should be signed by ?
1- Subject
2-Person who obtained consent
3-both

Answer 13

Subject and person who obtained consent

Question 14

Major sponsor of Clinical Research is

Answer 14

NIH

Question 15

The sponsor specific document should be retained until at least _____years after the last approval of marketing application?

Answer 15

2 years

Question 16

A study in which the mentally ill subject are taken off their regular medication?

1-Challenge Study
2-Placebo Study
3-Washout study
4-Symptoms Provocation Study

Answer 16

Washout Study

Question 17

The sponsor should use an unambiguous subject identification code ?

True or False

Answer 17

True

Question 18

What is IDMC ?

Answer 18

Independent Data Monitoring Committee

Question 19

Pharma is

Answer 19

Pharmaceutical Research and Manufactures of America

Question 20

Department of Veterans Affairs has the fallowing R&D areas

Answer 20

Clinical science, Health, Lab, Rehab

Question 21

Traceability Matrix is ______?

Answer 21

Used to ascertain validated states

Question 22

A prisoner representative include

Answer 22

Current or former prisoner
Prison Chaplin
Prison Social Worker

Question 23

Regulation 21 CFR 303.212 is cited as ____.

Answer 23

Title, Part, Section

Question 24

Section of CRF that deals with the Protection of human subjects in clinical trials is _____?

Answer 24

Section 50

Question 25

Protocol deviation is an example of Non-Compliance

True or False

Answer 25

True

Question 26

Regulation which apply to research involving pregnant women and fetuses as subjects referred to _____.

Answer 26

DHHS 46 subpart B

Question 27

ICH has _____Country Regions and _____Parties

Answer 27

3 and 6

Question 28

AE which is medically significant but not immediately life-threatening; hospitalizations /prolonged / disabling
Is scale grading _____?

Answer 28

Grade 3

Question 29

Consent can be obtained on an outdated form

True or false

Answer 29

False