Clinical Research Institute
The Clinical Research Institute is a complete training program in which our employees, who want to start in a position as CRA, follow an intensive training program in which knowledge, skills and competencies are developed. It is a “blended” program, both in classroom as well as e learning. After the initial training you start in the CRA-trainee program and you will be intensively coached and supported by our Project- and Training Manager. The training consists of the following modules:
- ICH-GCP e-learning
- Basic (Introduction)
- Design
- Preparation
- Submission
- Trial Start
- Conduct
- Close-out & Archiving
- Initial classroom training
- Introduction Clinical Research
- The World of Clinical Research
- Drug & Device Development
- Clinical Trial legislation, European and Dutch
- ICH-GCP implementation (E6-R2)
- Basic Clinical Trial Monitoring
- Clinical Trial Methodology and statistics (ICH E9)
- Clinical Trial Documentation
- Documenting monitoring activities
- Remote monitoring & Query writing
- Informed Consent Procedure
- Pharmacovigilance (ICH E2A)
- Investigational Product management
- Site conversations
- On-going training
- The protocol and the investigator brochure (IB)
- Quality Management
- Data Management
- Advanced Monitoring
- Site Selection Visit
- Site initiation
- Risk-based clinical trials
- Inspection readiness
- Filing & Archiving
- GCP training site
- Site closure
To support and develop our employees InnSense implements our Performance Management system through which knowledge, skills, competencies and result areas are evaluated. In perspective of the position of CRA we do this according to “CRA NVFG toetsmatrix 24-10-2016”.
Lifetime learning
Education, training and management of clinical staff
