What is the purpose of assigning unique code numbers to the investigational product(s) and to trial subjects?

• A. To track the investigational products and trial subjects while maintaining confidentiality.
• B. For marketing.
• C. For vendor evaluation.
• D. For randomization only.

Answer: (A)

Assigning unique code numbers to both the investigational products and the trial subjects creates a secure link between data points while protecting personal privacy. These codes let the study team trace which product and which lot a participant received, when doses were given, and how data, adverse events, and outcomes relate to each individual—without exposing names or identifiable details. This preserves confidentiality, supports accurate data management and inventory control, enables recalls if needed, and helps with regulatory audits and pharmacovigilance. In blinded trials, codes also help maintain blinding by masking treatment information from those collecting and analyzing data. While randomization is involved in how participants are allocated, the codes themselves primarily serve to maintain traceability and confidentiality across the study.