Course topics
CRAcademy can organize a broad range of training sessions in cooperation with the trainers.
Clinical Research
Data Management and Statistics
Soft Skills
Clinical Research
- Introduction to ICH-GCP
- Patient recruitment
- Advanced problems in clinical research
- Clinical Research in general
- Responsibilities for Sponsors, Investigators and Ethics committees according to ICH-GCP
- Regulatory requirements for clinical research in the Netherlands
- Regulatory requirements for clinical research in Europe
- History and infrastructure of clinical research in the Netherlands
- Plain Common Sense Guidelines with questions from daily research practice and cases
- Organization of research in hospitals and in the industry
- Audits and Inspections
- How to deal with suspected fraud
- Reporting of Serious Adverse Events and Adverse Drug Reactions to the authorities
- Design of study archives
- The Ethics Committee in general and in the Netherlands since the implementation of the Medical Research Involving Human Subjects Act
- The Pharmacist and Clinical Research
- Informed Consent procedure
- Applicable other regulatory requirements for clinical research in the Netherlands (Privacy laws)
- The Medical Research Involving Human Subjects Act in daily practice
Data Management and Statistics
- Data Entry and Query Writing
- Data Validation
- Dataset Specifications
- CRF Design
- SQL for Data Managers
- Methods & Technique in Research
- Epidemiology
- Clinical Trial design
- Meta-analyses
- SPSS
Soft Skills
- Influencing people – the art of negotiation in all aspects of clinical research
- Training and workshops in Skills, Synergy and Self-realisation
- Transformation, Project and Education Management
- Personal Coaching
- Mediation, Conflict conciliation
- Communication skills
- Presentation techniques
- Situational Leadership skills
- Time Management
- Planning and Organisational skills
- Decision Making and Team Development
If the topic you are looking for is not on this list, then please contact CRAcademy for other possibilities.
