Clinical Data Management (FDA E6 GCP Guidelines) is a conference that covers topics such as:
- Best practices for data collection
- Regulatory guidelines for Clinical Data Management
- Responsibilities of personnel
- CDISC/CDASH/STDM standards
- Maintaining confidentiality of data
- Case report form criteria
- Data preparation and quality assurance for accuracy
- Data storage and transferability
- Data systems validation
- Data monitoring plan criteria
- What to expect on a monitoring visit
- Adverse event reporting and coding criteria
- Troubleshooting and resolution of deviations from plan
Clinical Data Management (FDA E6 GCP Guidelines) brings together senior attendees involved or interested in:
- Data managers
- Study Investigators
- Statisticians
- Data processors
- Clinical Research Associates
- Site Personnel
- Study Sponsors
- Clinical Project Managers/Leaders
- Staff in the above fields who work with data collection/management and require training in CDM
- Professionals in pharmaceutical, medical device, clinical and biotechnology research who oversee or work with data collection and management
- Compliance auditors and regulatory professionals who require a knowledge of CDM in assessment of study protocols and reports
