practice exam questions

Question 1

ALCOA-C

Answer 1

attributable, legible, contemporaneous, original, accurate, complete

Question 2

Which term best describes an independent assessment of completed work to ensure it will meet applicable quality standards

Answer 2

quality assurance

Question 3

Which term best describes the activities done to ensure quality output?

Answer 3

quality control

Question 4

Which term requires structure and a definition of acceptable standards of performance?

Answer 4

quality planning

Question 5

when not completed correctly what is a major contributing factor to an ineffective corrective action plan

Answer 5

root cause analysis

Question 6

what are cyclical activities done as part of quality improvement

Answer 6

plan, do, check, act

Question 7

what are the basic steps of risk management

Answer 7

analyze risk, identify risk, control risk

Question 8

correct order of CAPA process

Answer 8

identify issue, determine root cause, implement plan for correction, assess effectiveness of correction

Question 9

what are some essential IRB documents

Answer 9

protocol, informed consent, investigator’s CV, information given to subjects, IB, available safety info, payments/compensation

Question 10

how often should continuing review occur

Answer 10

at least once per year

Question 11

investigator deviated from protocol to prevent immediate hazard. what should they do?

Answer 11

immediately report to IRB

Question 12

what are the required elements of an investigator’s brochure

Answer 12

title page, confidentiality statement, summary, introduction, chemical, physical, and pharmacological properties, non-clinical studies, effects in humans, summary of data and guidance for investigator

Question 13

comparator

Answer 13

investigational or marketed product (active control) or placebo used as a reference in a clinical trial

Question 14

what files are the advertisements for subject recruitment kept in

Answer 14

investigator/instutition

Question 15

sample of label’s attached to the investigational product are kept in whose files

Answer 15

the sponsor’s

Question 16

master randomization list is kept with the

Answer 16

sponsor

Question 17

pre-trial monitoring report is kept with the

Answer 17

sponsor

Question 18

certificates of analysis for new investigational batch is kept with the

Answer 18

sponsor

Question 19

monitoring visit reports are kept with the

Answer 19

sponsor

Question 20

subject identification code list is kept with the

Answer 20

investigator/institution

Question 21

subject enrollment log is kept with the

Answer 21

investigator/institution

Question 22

audit certificate is kept with the

Answer 22

sponsor