Quality control is primarily associated with which activity?

• A. Establishing processes to prevent quality problems.
• B. Detecting and correcting issues in data and processes.
• C. Scheduling trial visits.
• D. Formatting study documents.

Answer: (B)

Quality control focuses on finding and fixing problems in data and in how activities are carried out. In practice, this means ongoing checks such as verifying that data entered in case report forms matches the source documents, identifying and resolving discrepancies, reviewing data for accuracy, and taking corrective actions to prevent the same issues from occurring again. The goal is to ensure data integrity and adherence to the protocol and trial procedures. This differs from quality assurance, which is about designing and improving the processes themselves to prevent problems. Scheduling trial visits or formatting study documents are not QC activities; they are part of trial management and documentation tasks, respectively.