The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of trial-related activities have been fulfilled.
Quality control represents the tactical implementation of quality verification activities throughout clinical trial conduct. While quality assurance establishes the systems and standards for quality, quality control involves the specific checks and reviews that verify compliance with those standards. QC activities are typically embedded within operational processes rather than functioning as an independent oversight function.
QC activities in clinical trials take many forms depending on the specific processes being controlled. Data quality control includes edit checks in electronic data capture systems, medical coding review, and manual verification of critical data points. Document quality control encompasses review of essential documents for completeness and accuracy before filing. Process quality control involves verification that procedures are followed correctly, such as confirming that samples are processed according to specified protocols.
The integration of quality control into routine operations represents a key principle of modern quality management. Rather than relying solely on end-stage inspection to identify problems, effective QC builds verification into each process step. This approach enables earlier detection of issues, reduces rework, and produces higher quality outputs. The specific QC activities implemented should be proportionate to the risks associated with each process, consistent with the risk-based approach emphasized throughout ICH E6(R3).
Data review
"The data management team performed quality control reviews of all serious adverse event reports within 24 hours of entry, verifying completeness and consistency before submission to the safety database."
Process verification
"As a quality control measure, a second person verified all randomization assignments by checking that the treatment allocated matched the randomization system output."
A systematic and independent examination of trial-related activities and documents to determine whether evaluated activities were conducted in accordance with the protocol, GCP, and applicable regulatory requirements.
All planned and systematic actions established to ensure that the trial is performed and data are generated, documented, and reported in compliance with GCP and applicable regulatory requirements.
A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
A monitoring approach that focuses oversight activities on the most critical data and processes, allocating resources based on risk assessment rather than applying uniform monitoring intensity across all aspects of a trial.
A process of comparing data collected in the case report form against source documents to confirm that the data were transcribed accurately and completely.
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