Identify common GLP study roles beyond the Study Director.

• A. External auditors and patients.
• B. Laboratory technicians.
• C. Sponsor, QA Unit, Study Monitor, Principal Investigator (where applicable), and Intervention staff.
• D. Only Study Director.

Answer: (C)

In GLP, many roles collaborate to ensure the study is planned, executed, and reviewed with integrity and compliance. Beyond the Study Director, the standard set includes the sponsor, the QA unit, the study monitor, the principal investigator where applicable, and the intervention staff. The sponsor funds and initiates the study and defines the required outcomes and expectations; the QA unit provides independent quality assurance, auditing processes, and safeguards to verify that GLP principles are followed throughout data collection and reporting; the study monitor acts as a bridge to oversee the study’s progress, ensuring procedures are followed, data is collected accurately, and any deviations are addressed promptly; the principal investigator (when applicable) leads the scientific conduct at the site, ensuring the protocol is implemented correctly and the scientific rationale remains sound; and the intervention staff carry out the specific procedures or administration as defined in the protocol. This combination covers funding, oversight, scientific execution, and hands-on procedures, which is why it best represents the common GLP study roles beyond the Study Director. External auditors and patients aren’t routinely part of the core GLP study team, laboratory technicians are essential but don’t alone capture the full governance and oversight structure, and limiting to only the Study Director ignores the broader framework that GLP requires.