Do you want to understand more deeply the sponsor co-monitoring practice and how this yield benefits in clinical research? Several sponsors have developed successful co-monitoring strategies, but do we understand how critical this is in terms of not merely CRA oversight but for overall conduct of the clinical trial. This course provides you with the grounding that will allow you to understand the most salient aspects of co-monitoring practise.
During a one-day face-to-face course in which presentations are blended with interactive sessions with the attendees, you will receive a good oversight on regulations guiding co-monitoring, principles of CRA oversight, tools and methodologies, and above all comprehensive guidance how co-monitoring can improve conduct and quality of your clinical trial.
The course will present real life case studies and examples where either CRA performance or indeed site performance has not been adequate and will use interactive workshops to find ideal solutions. Exercises for self-assessment are used to enhance your understanding of the main topics discussed in the course. You will be able to test your comprehension with a final grading assessment.
Course time09h00 - 17h00
Who should attend
All clinical development personnel at Sponsor involved in any aspects of co-monitoring/CRO oversight (Senior CRAs, Clinical Trial Managers, Project Managers, Line Managers, Medical Directors, Project Leaders, QA Auditors)
- Principles of CRA oversight
- Tools, methodologies and preparation for co-monitoring
- Co-Monitoring plan
- Guidance how co-monitoring can improve conduct of the clinical trial.
- Appreciate the regulations and guidance relevant to co-monitoring
- Understand concept of sponsor responsibility
- Gain insight principles of monitoring oversight
- Identify overall benefits to the clinical trial conduct that co-monitoring can offer
- To learn best practice and tools for co-monitoring
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical Participants Safety Considerations (0)
- Investigational Product Development and Regulation (2)
- Clinical Studies Operations (GCPs or ISO 14155) (2)
- Study and Site Management (1)
- Data Management and Informatics (1)
- Leadership and Professionalism (2)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained