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1. A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?

A) Draft a CAPA plan
B) Establish a DSMB/IDMC
C) Develop a monitoring plan
D) Conduct routine investigators' meetings

2. Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

A) Protocol, site coordinator CVs, and clinical trial agreement
B) IB, site coordinator CVs, and information about payments and compensation available to subjects
C) Protocol, IB, and information about payments and compensation available to subjects
D) Protocol, informed consent, and clinical trial agreement

3. The sponsor should supply a PI with the IP after:

A) Approval of protocol by the sponsor.
B) Approval/favorable opinion from IRB/IEC and regulatory authority.
C) Approval of protocol by the PI.
D) Submission of documents to IRB/IEC and regulatory authority for review.

4. In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

A) Privacy controls
B) Blinding
C) Placebo-controlled
D) Randomization

5. Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

A) Train the research coordinator on the required study assessments schedule.
B) Identify critical processes and data during protocol development.
C) Perform a periodic review to see if the quality methods are effective and relevant.
D) Determine the quality tolerance limits for data transcription errors.

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