Background Checking is essential to ensure the quality of clinical data while a clinical trial is in progress. This process promotes adherence to GCP as defined:
Guidance for Industry Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring – FDA
Reflection paper on risk-based quality management in clinical trials – EMA
Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products – MHRA
Purpose To demonstrate that Quality Assessment (QA) is essential to ensure the quality of non-profit research.
Materials and methods The QAs path is developed through Quality Assurance (QA) and Quality Control (QC) audits. All trials are given a risk class that defines the methods and timing of intervention. That risk class is obtained by creating a table within a specific matrix. The card brings together some 81 parameters that characterise the experiment. The audit activity at the centre is scheduled only for studies belonging to risk class III-IV. During the QA and QC checklists are used:
Risk Management QA
Risk Management QC
whose elaboration in a separate matrix allows the re-programming. QA activities refers to all practices that were approved from 1 January 2011 to 31/12/2012, because processing is done every six months.
Results To date, a risk class has been assigned to 53 studies, of which 34 are active. All centres have been subjected to at least one QA or QC check, in order to eliminate the deviations and violations and comply with the quality requirements defined by GCP. 30 studies required a second QA check and 17 studies required quality control. 6 studies still needed a third revision of QA and 9 studies a second quality control. During the audit it was found that 41% of the studies did not comply with GCP regarding management of the Investigator’s File, for 22% to do with compliance with the SOP, for 21% to do with compilation of the CRF, 11% IMP (investigational medicinal product) management and accounting, 6% regarding reporting of adverse events and 11% compared to the protocol. The risk class of the studies after the audit has remained the same, except for one study, which was terminated early because of the increased risk, and for 3 class 3 studies that were so well run the risk class was reduced.
Conclusions Usually, two audits were sufficient for full compliance with the requirements defined in the GCP. This project improved the protection of the subjects, increased the quality and integrity of data and got rid of practices and processes that did not add value to the clinical trial (s), thus optimising the efficiency of monitoring. Through intelligent allocation of resources for monitoring trials, sponsors have the opportunity to realise significant time and cost savings while maintaining or even increasing quality.
No conflict of interest.
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