Question

What do sponsor audits, monitoring visits, and regulatory inspections have in common?

a) They all involve site personnel
b) They assess compliance with regulations and protocols
c) They focus solely on patient safety
d) They occur only during the initiation phase

Answer 1

Sponsor audits, monitoring visits, and regulatory inspections assess compliance with regulations and protocols in research studies.

Step-by-step explanation:

Sponsor audits, monitoring visits, and regulatory inspections have in common that they all assess compliance with regulations and protocols. These activities are conducted to ensure that clinical trials and research studies are being conducted in accordance with the approved protocols and regulatory requirements. They involve evaluating various aspects of the study, including documentation, patient safety, data integrity, and adherence to ethical standards.

For example, sponsor audits are conducted by the sponsor or their designated representatives to review the conduct of the study and ensure that it meets the required standards. Monitoring visits are conducted by the sponsor or their representatives to oversee the progress of the study and ensure compliance with protocols. Regulatory inspections are conducted by regulatory authorities to assess compliance with regulations and identify any non-compliance or deficiencies.