What is the primary purpose of documenting normal values/ranges for medical, laboratory, or technical procedures included in the protocol?

• A. To establish reference values for interpreting results
• B. To confirm sponsor funding levels
• C. To determine enrollment criteria
• D. To identify investigational product labels

Answer: (A)

Normal values or reference ranges give a benchmark for interpreting every result in the protocol. By stating what is typical for the specific test method and the population, investigators can decide quickly whether a result is within expected limits or indicates something abnormal that needs safety review, follow-up, or a protocol action. This standardization across sites helps ensure consistent interpretation and decision-making, and it keeps results meaningful by tying them to clinically relevant context (such as age- or sex-specific ranges and the method used). Administrative items like sponsor funding, enrollment criteria, or product labeling aren’t about interpreting results, so they aren’t the primary purpose of documenting normal values.