POSTDOC: Electronic Data Capture and Data Management For Principal Investigators In Clinical Trials Phase 3

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This is a 5 day course for postdoc researchers who have already conducted and published at least one clinical trial and have PhD in Medical sciences or Physiotherapy sciences. Cost per person is 590€. Participants travel and accommodation costs can be financed through Erasmus “Staff mobility for training” fund. The course includes the following topics:

  • Electronic data capture systems, review and a case study with openclinica and medrio software
  • Case Report Forms: issues and obstacles when migrating from paper to EDC forms (CRF -> eCRF migration)
  • Clinical data management systems, a review
  • Cloud based clinical data management systems, a review
  • Introduction to XML and JSON, clinical interoperability and accessibility/security considerations
  • Introduction to REST/GRAPHQL and understanding the importance of RESTFUL infrastructure
  • Managing multi-site clinical trials, tips and tricks for trial coordinator
  • Overview of CDISC and its guidelines
  • GDPR, FISMA, HIPAA compliance and regulation
  • Electronic health record design objectives and considerations
  • Introduction to eudravigilance and automatic XML reporting to MedDRA database
  • Sample size calculation with G power
  • Biostatistics and ethical considerations: parametric tests, significance, confidence assessment

Courses are planned when there are at least 3 participants interested in the same time-frame. Anyhow we try to be reasonable and try to provide you most networking, knowledge, skills, and insights to stay ahead in the industry. Apply with your CV and your expressed motivation at info at irzu.org