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After you’ve had a chance to read through the book, spend a few minutes on this quiz to test yourself. Our perspective on the “correct answers” is included following the quiz.

  1. Considerations for strategic policies include:

    1. the size of the research enterprise.

    2. those that support ways of reaching or exceeding enrollment targets.

    3. those that support focusing administrative effort on activities such as invoicing and monitoring the revenue stream.

    4. All of the above

  2. The break-even point in a clinical trial is:

    1. when the investigator completes enrollment.

    2. irrelevant when the purpose of the trial is important.

    3. when expense equals revenue.

    4. already calculated by the sponsor and is factored into their budget proposal.

  3. Hiring research personnel should be based on:

    1. how busy the research staff seem.

    2. replacing staff who have resigned.

    3. each investigator having a dedicated research coordinator.

    4. a thorough evaluation and written justification.

  4. Clinical trial effort equals the time to complete study visits for subjects plus the time the investigator and research staff will spend on:

    1. setting up regulatory documents, processing protocol amendments, annual continuing review, and monitoring visits.

    2. processing, shipping, and storing any protocol related specimens.

    3. communicating with the study sponsor, completing screening logs, assigning subject medical charges to the grant, and reconciliation of sponsor payments.

    4. All of the above

  5. Strategies for working with research subjects include:

    1. regularly discussing the study purpose, their rights as research subjects, and the schedule of events.

    2. providing the contact information so they can communicate with the investigator and research staff.

    3. providing clinical care and medical advice.

    4. a & b

  6. Appropriate activities for an audit include:

    1. clarifying the purpose of the audit.

    2. notifying the investigator and the institution’s compliance personnel.

    3. answering the auditor’s questions honestly and providing requested documents.

    4. All of the above

QUIZ RESPONSES—OUR PERSPECTIVE

  1. Considerations for strategic policies include:

    1. the size of the research enterprise. Strategic policies are critically important for small and large research enterprises even though other aspects of their operations may differ.

    2. those that support ways of reaching or exceeding enrollment targets. Policies should include feasibility assessments to determine the likelihood of reaching enrollment targets and a customized recruitment plan.

    3. those that support focusing administrative effort on activities such as invoicing and monitoring the revenue stream. Investigators need to be proactive because slow payments are not unusual.

    4. All of the above. We believe all of these answers are important considerations for strategic research policies.

  2. The break-even point in a clinical trial is:

    1. when the investigator completes enrollment. The number of subjects enrolled is only a part of the equation and may not cover the site’s study-related expenses.

    2. irrelevant when the purpose of the trial is important. The investigator may feel the research trial is important and have professional reasons for conducting it. The investigator should have a plan in place to cover the expenses of conducting the trial.

    3. when expense equals revenue. We believe this is the correct response.

    4. already calculated by the sponsor and is ...

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