CITI Training Practice Exam

Where is investigational product dispensing or administration info recorded?

1. In the Pharmacy Log

2. In the Investigator's Manual

3. On the Case Report Form

4. In the Sponsor's Database

The correct answer is: On the Case Report Form

This is because the case report form (CRF) is the standard document used to collect information in clinical trials and is designed to capture data on investigational product dispensing and administration. The pharmacy log may track the dispensing of all medications, but it does not provide specific information about the investigational product. The investigator's manual may provide instructions for dispensing or administering the investigational product, but it is not a formal record of this information. The sponsor's database may also contain information about the investigational product, but it is not the primary source for recording this data. Therefore, the CRF is the most appropriate place for recording investigational product dispensing or administration information.