CITI TRAINING GOOD CLINICAL PRACTICE
KEY CONCEPTS AND PRACTICE QUESTIONS
◉ In addition to planning and initiating, what are the other phases
of project management?
Answer: Executing, monitoring, and closing
◉ When managing multiple trials, it is most helpful to:
Answer: Develop standard forms, documents, and source data
templates that can be used across multiple trials
◉ Goals in project management should be SMART. What does the "A"
stand for as a quality of SMART goals?
Answer: Attainable
◉ A CRC writes a goal down as "Recruit more subjects." Is this a
SMART goal (Specific, Measurable, Attainable, Relevant, and Time
bound)?
Answer: No
◉ A methodology borrowed from business to improve performance
by removing waste and reducing variation, through work
standardization and flow with a team-based approach is:
, Answer: Lean Six Sigma
◉ Research misconduct can become regulatory noncompliance
when:
Answer: A researcher submits false information to the FDA or
sponsor in a required report
◉ The difference between misconduct and honest error is:
Answer: Intent
◉ A paper has been prepared for publication from available study
data. A CRC who assisted in data collection and publication
preparation submitted the final draft of the paper to the PI for
review. One of the tables indicated low study enrollment numbers.
In the presence of the CRC, the PI crossed out the numbers on the
table and wrote in a series of new numbers to increase the
enrollment numbers. The publication was revised for consistency
(with the updated enrollment numbers) then submitted, accepted,
and published. What type or or types of misconduct occurred?
Answer: Fabrication and Falsification
◉ Corrective action plans are used for:
Answer: Respond to noncompliance findings with actions
KEY CONCEPTS AND PRACTICE QUESTIONS
◉ In addition to planning and initiating, what are the other phases
of project management?
Answer: Executing, monitoring, and closing
◉ When managing multiple trials, it is most helpful to:
Answer: Develop standard forms, documents, and source data
templates that can be used across multiple trials
◉ Goals in project management should be SMART. What does the "A"
stand for as a quality of SMART goals?
Answer: Attainable
◉ A CRC writes a goal down as "Recruit more subjects." Is this a
SMART goal (Specific, Measurable, Attainable, Relevant, and Time
bound)?
Answer: No
◉ A methodology borrowed from business to improve performance
by removing waste and reducing variation, through work
standardization and flow with a team-based approach is:
, Answer: Lean Six Sigma
◉ Research misconduct can become regulatory noncompliance
when:
Answer: A researcher submits false information to the FDA or
sponsor in a required report
◉ The difference between misconduct and honest error is:
Answer: Intent
◉ A paper has been prepared for publication from available study
data. A CRC who assisted in data collection and publication
preparation submitted the final draft of the paper to the PI for
review. One of the tables indicated low study enrollment numbers.
In the presence of the CRC, the PI crossed out the numbers on the
table and wrote in a series of new numbers to increase the
enrollment numbers. The publication was revised for consistency
(with the updated enrollment numbers) then submitted, accepted,
and published. What type or or types of misconduct occurred?
Answer: Fabrication and Falsification
◉ Corrective action plans are used for:
Answer: Respond to noncompliance findings with actions
