Quality Assurance & Reporting Overview
Assess compliance with Good Clinical Practice (GCP) and other applicable regulations, evaluate institutional performance, monitor adherence to protocol criteria, inspect quality and integrity of clinical trial data, provide education to audited site staff, identify and resolve systematic issues identified through QA reviews, manage corrective and preventative action plan process.
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Quality Assurance
The CTDD quality assurance and reporting function promotes the highest level of scientific integrity and the protection of human subjects who participate in research studies. The quality assurance team has extensive expertise and experience in developing and performing comprehensive evaluations across a broad range of clinical research protocols.
The audit/monitoring program supports quality assurance objectives through examination of investigator performance in complying with protocol requirements, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) GCP, as well as other applicable or specified regulations. The selection of quality participating institutions is an important strategy in protecting against poor adherence to protocol criteria and poor data quality.
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Quality Control
Quality control objectives are supported through processes which include protocol review, site education, identification/resolution of systematic issues, SOP development, etc. Education and training pertinent to overall processes, as well as individual protocols, is provided to participating institution principal investigators and research staff. This typically occurs by utilizing audits/monitoring to provide instantaneous specific educational information based upon deficiencies noted. The team also uses reviews as opportunities to share best practices observed across all participating institutions that may lead to improved performance. The interaction between reviewers and institutional research staff also provides valuable insight regarding systemic problems and/or proactive practices. This knowledge is incorporated into network-wide targeted educational programs or broadcasts. Flexibility and innovation are utilized to enhance and tailor processes to meet protocol requirements.
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Corrective And Preventative Action
Experienced researchers oversee and manage the follow-up (corrective and preventative action) process to ensure that sites act on all significant findings of concern. Any irregularities identified through quality assurance and control processes that raise suspicion of fraud or intentional misrepresentation of data are immediately reported according to protocol directives.
The CTDD provides quality assurance and quality control systems to ensure that the highest level of quality data are generated, documented, and reported in compliance with the research protocol. A wide range of processes and activities across the four functional areas within the CTDD (Biostatistics and Statistical Programming, Clinical Trials Management, Quality Assurance and Reporting, and Information Technology) work in concert to monitor, ensure, and improve data quality and human subject protection.