CHCUK Ltd

NIS Considerations (Ireland)

NIS Considerations (Ireland), explains the practical considerations and challenges when conducting non-interventional studies in Ireland

Course Objectives:
The course aims to explain the practical considerations and challenges when conducting non-interventional studies in Ireland

Course Outline:
The course is split into 2 modules and includes a certificate of completion.  It is estimated that  the course will take 30 minutes to complete.

Module 1: Revisits the generic practical considerations and challenges when conducting non-interventional studies
Module 2: Explore the Country-specific requirements when conducting NIS in Ireland and looks specifically at:
 

  • Regulatory classification
  • Regulatory framework/applicable legislation and guidelines
  • Approval requirements
  • Submission documents
  • Responsibilities
  • Practical considerations
  • Mental incapacity
  • Human tissue research
  • Industry best practice


Course Format:

  • Includes reminders at the end of each module
  • Has an audio commentary
  • Includes supporting tools and resources


A certificate of completion is issued to all participants who complete the course