SOCRA CCRP Practice Exam

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What should be included in the 'Treatment of Subjects' section of the protocol?

  1. Screening procedures

  2. Details about the administration of the investigational product, including storage and accountability

  3. Consent process

  4. Data management plan

The correct answer is: Details about the administration of the investigational product, including storage and accountability

The 'Treatment of Subjects' section of the protocol should include details about the administration of the investigational product, including storage and accountability. This section should not include details about screening procedures (A) as those should be outlined in the 'Selection of Subjects' section. The consent process (C) should be discussed in the 'Informed Consent' section of the protocol. The data management plan (D) should be included in the 'Data Collection and Management' section. It is important to include specific and detailed information about the investigational product in the 'Treatment of Subjects' section to ensure that the subjects are properly and consistently treated during the study.

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