For each testing facility that archives its own raw data, the procedures that describe how it will be done are:

• A. Described in the protocol
• B. Determined to be adequate by testing facility management and described in standard operating procedures (SOPs)
• C. Decided by the sponsor
• D. Not required

Answer: (B)

In GLP, how raw data are archived is controlled through standard operating procedures that the facility’s management approves (often with QA review). These SOPs provide the step-by-step, repeatable method for preserving original data, ensuring they remain intact, traceable, and retrievable over time. The protocol focuses on how the study will be conducted and how data are generated, not on the ongoing archival steps. The sponsor may set study requirements, but the facility is responsible for its own data archiving procedures, and these must be documented and approved. Not having documented archival procedures would undermine data integrity and regulatory compliance.