Which document records the normal values and ranges for tests used in the protocol?

Which document records the normal values and ranges for tests used in the protocol?

• A. Normal Values/Ranges for Medical/Laboratory/Technical Procedures and/or Tests Included in the Protocol
• B. Medical/Laboratory/Technical Procedures/Tests
• C. IRB/IEC Composition
• D. Dated, Documented Approval/Favorable Opinion of IRB/IEC

Answer: (A)

In clinical trials, interpreting lab and test results consistently hinges on having predefined reference ranges for the tests used in the protocol. The document that records the normal values and ranges for medical, laboratory, or technical procedures and/or tests included in the protocol provides exactly those reference values, along with acceptance criteria investigators apply when evaluating results. This ensures uniform interpretation across sites and over time, and helps identify out-of-range findings that may affect safety or eligibility. The other documents serve different roles: one lists the procedures or tests to be performed, not their reference values; another states who sits on the ethics review body; and another records the ethical approval status.

In clinical trials, interpreting lab and test results consistently hinges on having predefined reference ranges for the tests used in the protocol. The document that records the normal values and ranges for medical, laboratory, or technical procedures and/or tests included in the protocol provides exactly those reference values, along with acceptance criteria investigators apply when evaluating results. This ensures uniform interpretation across sites and over time, and helps identify out-of-range findings that may affect safety or eligibility.

The other documents serve different roles: one lists the procedures or tests to be performed, not their reference values; another states who sits on the ethics review body; and another records the ethical approval status.