What must QA/QC ensure about data?

• A. Data are generated, documented, and reported in compliance with the protocol, GCP, and applicable regulatory requirements
• B. Data can be generated arbitrarily
• C. Only the documentation matters
• D. Compliance is optional

Answer: (A)

QA/QC is about ensuring data integrity throughout the study—from how data are generated to how they are documented and finally reported. Data must be produced according to the study protocol and adhere to GCP and applicable regulatory requirements. This means the data are accurate, complete, and traceable, with proper source documentation, timely entries, and appropriate handling of any changes or deviations. Only then can the results be reliable and acceptable to regulators and protect participant safety.

If data could be generated arbitrarily, or if only documentation mattered, or if compliance were optional, the trial’s credibility and regulatory acceptability would be at risk.