SOCRA CCRP Practice Exam

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Which document is exclusively kept by the sponsor before a trial?

  1. Signed ICFs

  2. Sample of IP labels

  3. IRB approval

  4. Decoding procedure

The correct answer is: Sample of IP labels

The other options refer to documents that are important for a clinical trial, but are not exclusively kept by the sponsor. For example, signed ICFs may also be kept by the investigator and IRB approval is typically shared with all parties involved in the trial. Decoding procedures may also be shared with the Data Safety Monitoring Board. The only document exclusively kept by the sponsor before a trial is a sample of IP labels, as these are not typically shared with other parties and are important for the sponsor to keep track of the investigational product.

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