Clinical Data Management - A Beginners Guide
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Clinical Data Management (CDM) involves the process of collecting, storing, managing, analyzing, reporting, submitting and archiving clinical data generated from clinical trials which are conducted as a part of the drug development process, to ensure good quality, clean data that is fit for submission to the regulatory authorities.
“Clinical Data management, A Beginner’s Guide” is intended for students and enthusiasts willing to make a career in clinical data management. The book first describes the processes involved in developing a new drug (drug discovery, pre-clinical development and clinical development) and then explains each of these processes in detail with special emphasis on computer systems and methods that are used for the same in the industry today.
The book is a resource on the following topics:
• Overview of R&D in the Pharmaceutical Industry
• Drug discovery process
• Phases of Drug development
• Overview of Clinical Data Management
• Methods of Clinical Data Collection and Management
• Clinical Data Management System (CDMS)
• Oracle Clinical – A Case Study
• 21 CFR Part 11 regulations
• Form and System Design
• Selecting, validating, installing and configuring a CDMS
• Patient Management
• Quality Assurance
• Handling AE’s and SAE’s
• Database Lock and Freeze
• Retention and Archival of Clinical Data
• Electronic Data Capture (EDC)
• Clinical Data Interchange Standards Consortium (CDISC)
