About the course
Obtaining scientific valid data leading to successful demonstration of results on a medical device are the ultimate objectives of the investment in a clinical investigation. Well prepared case report forms and related logistics and data management are the most important tools to reach such objectives in the most optimal manner. This course provides ready to use tolls that clinical research professionals can use to reach such objectives.

Course Agenda
• Definition of a case report form
• Compliance with the clinical investigation plan
• Compliance with the regulations
• Roles and Reponsabilities
• Standard Case Report Forms, examples
• Do's and Don't's, examples
• Sign off rules
• Guidance for completion
• Laboratory results
• General design rules
• Data flow and QC steps
• Related procedures

Who should attend
Clinical research managers, clinical research associates and professionals involved in data collection and data management who will want to gain improved expertise in designing effective case report forms using the course leader's practical experience.


For information on booking D-TARGET training courses, please contact us.