Practical Guide to Quality Management in Clinical Trial Research

Practical Guide to Quality Management in Clinical Trial Research

CRC Press

Examining how to maintain assured quality in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides solid foundations, tips, and techniques for establishing a quality system that will comply with the relevant regulations. This book offers useful information for various standards including Good Laboratory Practice, Good Clinical Practice, and Good Manufacturing Practice. It gives detailed explanations of how to prepare, update, and maintain Standard Operating Procedures and also includes advice on training and development of personnel. This text is ideal for clinical trial monitors and quality assurance personnel in the pharmaceutical industry. > Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Qualh

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