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

Future Events

Clinical Data Management (FDA E6 GCP Guidelines) 2020

Important

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

Prices are for evaluation only.

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