SOCRA CCRP Practice Exam

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Which additional document is only kept by the investigator during a trial?

  1. Communications

  2. Subject ID list

  3. Sample of IP labels

  4. Certificates of analysis for IP

The correct answer is: Subject ID list

The additional document that is only kept by the investigator during a trial is the Subject ID list. This list contains identifying information for each participant in the trial, such as their initials or study number. Option A, communications, are typically kept by both the investigator and sponsor. Option C, a sample of IP labels, is typically kept by the sponsor to ensure consistency in labeling. Option D, certificates of analysis for IP, are also typically kept by both the investigator and sponsor to ensure quality control.

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