As the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a whitepaper that discusses the principles of risk management and their application to clinical research.
Topics: Risk Management, FDA, Clinical Research
As the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a whitepaper that discusses the principles of risk management and their application to clinical research.
The guidance documents for good clinical practice (GCP), ICH E6 and ISO14155, state the sponsor is responsible for quality assurance and quality control within a clinical trial. To achieve this, the sponsor must invest resources into these different aspects of a clinical trial. One specific aspect of integrating quality involves how risks are approached and managed throughout the course of a study. Both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) released documents in 2013 focused on the integration of traditionally development and manufacturing quality principles, including risk-based approaches into the clinical research industry. FDA’s “Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” and EMA’s “Reflection paper on risk based quality management in clinical trials” both describe how regulators now expect a quality, risk-based approach when conducting clinical research. These documents are examples of the shift toward quality techniques underway within industry when developing, initiating, and executing studies.
Topics: Risk Management, IMARC Whitepaper, FDA
As the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a whitepaper that discusses the principles of risk management and their application to clinical research.
Topics: FDA Guidance, Risk Management, IMARC Research Whitepaper
Please take time to review Emily Haglund’s article “Risk Management in Clinical Research Process and Application” that was recently posted on GxP Lifeline. The applicable guidances for good clinical practice (GCP), ICH E6 and ISO14155, state explicitly that the sponsor is responsible for quality assurance and quality control. One aspect of quality involves how risks are approached and managed throughout the course of a clinical trial, and is the focus of this article.
Topics: Risk Management, Emily Haglund, GxP Lifeline, Clinical Research
As the regulators continue to raise the bar for quality clinical research investigations, IMARC has released a new whitepaper that discusses the principles of risk management and their application to clinical research.
Topics: Whitepaper, Risk Management, Guidance Document, IMARC Research, FDA
