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

First course is planned for January 17th – January 26th (course runs on weekends too). Apply with your CV and motivation letter at info at irzu.org