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.
Risk management strategies can and should be applied to the clinical research industry, FDA and EMHA have released guidance documents that discuss and reference the incorporation of these principles into the clinical trial development, execution, and closure. The advantage of incorporation of these quality principles is an investment into the overall success of the clinical trial and will save time, resources, and likely eliminate, prevent, and/or minimize subject safety and data integrity risks.
Please feel free to download the article and share your thoughts with us.