Clinical Data Management (FDA E6 GCP Guidelines)


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

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Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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