Clinical Data Management (CDM)

This seminar is based on FDA E6 GCP Guidelines which are the basis of effective data quality management. Even if your research is not FDA regulated, the information you learn in this course will help to ensure a robust data collection and management plan.

Learning Objectives:

• Regulatory guidelines for Clinical Data Management
• Best practices for data collection
• CDISC/CDASH/STDM standards
• Responsibilities of personnel
• Case report form criteria
• Maintaining confidentiality of data
• Data storage and transferability
• Data preparation and quality assurance for accuracy
• Data monitoring plan criteria
• Data systems validation
• Adverse event reporting and coding criteria
• What to expect on a monitoring visit
• Troubleshooting and resolution of deviations from plan

Who will Benefit:

• Study Investigators
• Data managers
• Data processors
• Statisticians
• Site Personnel
• Clinical Research Associates
• Clinical Project Managers/Leaders
• Study Sponsors
• Professionals in pharmaceutical, medical device, clinical and biotechnology research who oversee or work with data collection and management
• Staff in the above fields who work with data collection/management and require training in CDM.
• Compliance auditors and regulatory professionals who require a knowledge of CDM in assessment of study protocols and reports