Feedback Lecture 9 Quiz

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Question 1
Which of the following is TRUE about a Quality Management Plan? (Select all that apply.) Your Answer Score Explanation It identifies roles and titles of individuals responsible for tasks It is a system to describe how a clinical trial site will be organized and structured to ensure compliance with GCP, regulatory, and institutional requirements It is an SOP (Standard Operating Protocol) It describes overall systems, processes, and tools Total Question Explanation A Quality Management Plan is a system to describe how a clinical trial site will be organized and structured to ensure compliance with GCP, regulatory, and institutional requirements; describes overall systems, processes, and tools; and identifies roles and titles of individuals responsible for tasks. 0.33 0.33 -0.33 0.33 0.67 / 1.00

Question 2
A Quality Management Plan includes which of the following? Your Answer Score Explanation All of these options Total Question Explanation 1.00 1.00 / 1.00

A Quality Management Plan includes Investigator and designee responsibilities, essential document compliance, and community outreach efforts and recruitment.

Question 3
Which of the following is the correct order of the steps in a Continuous Quality Improvement Cycle? Your Answer Score Explanation

Plan, implement, review, follow-up Total Question Explanation

1.00 1.00 / 1.00

The correct order of the steps in a Continuous Quality Improvement Cycle is: Plan, implement, review, follow-up.

Question 4
Which of the following is TRUE about the Sponsor/Investigator meeting? Your Answer Score Explanation It is scheduled before the protocol opens Total Question Explanation 1.00 1.00 / 1.00

The Sponsor/Investigator meeting is scheduled before the protocol opens.

Question 5
Which of the following are considered Essential Documents? Your Answer Score Explanation All of these options Total Question Explanation 1.00 1.00 / 1.00

Volunteer information forms, data collection forms, and case report forms are all considered Essential Documents.

Question 6
Which of the following are considered Essential Documents? Your Answer Score Explanation All of these options Total Question Explanation 1.00 1.00 / 1.00

IRB (Institutional Review Board) composition, insurance statement, and Curriculum Vitae (CV) of the investigator are all considered Essential Documents.

Question 7

Which of the following are considered Essential Documents? Your Answer Score Explanation All of these options Total Question Explanation 1.00 1.00 / 1.00

Laboratory certification and accreditation, samples of vaccine product labels, and master randomization list are all considered Essential Documents.

Question 8
Which of the following is TRUE about Standard Operating Procedures (SOPs)? (Select all that apply.) Your Answer Score Explanation They are the responsibility of the sponsor They are detailed written instructions to achieve uniformity of the performance of trial procedures They are the responsibility of the investigator They are used for internal training of study staff Total Question Explanation Standard Operating Procedures (SOPs) are detailed written instructions to achieve uniformity of the performance of trial procedures, are used for internal training of study staff, and are the responsibility of the sponsor. 0.00 0.33 0.00 0.00 0.33 / 1.00

Question 9
Which of the following is TRUE about Standard Operating Procedures (SOPs)? (Select all that apply.) Your Answer Score Explanation It should list the names of study staff performing the task It should list the ordering information or brand of specific or unusual supplies It should have a very long title It should include methods for assuring the quality of the process Total -0.50 0.50 0.00 0.50 0.50 /

1.00 Question Explanation Standard Operating Procedures (SOPs) should list the ordering information or brand of specific or unusual supplies and should include methods for assuring the quality of the process.

Question 10
Which of the following is TRUE about Study-Specific SOPs? (Select all that apply.) Your Answer Score Explanation They may include laboratory procedures They can vary by study They are not considered a type of Essential Document They include procedures that are unique for the protocol, vaccine, target population, and site Total Question Explanation Study-Specific SOPs can vary by study; include procedures that are unique for the protocol, vaccine, target population, and site; and may include laboratory procedures. 0.33 0.00 0.00 0.33 0.67 / 1.00