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Key Topics

Risk assessment

Risk management

Risk based monitoring

Central monitoring

Safety reporting

Computerised systems

Validation of computerized systems

IMP handling according to GCP

EU Annex 13

Sponsor oversight

Q&A and audit plan

Protocol deviation and CAPA

Handling of data

(e) TMF

Course Description

This 3-day interactive advanced GCP course is recommended for those who have experience in the clinical trial process and wish to develop their skills.

The course involves active interaction between the trainers and the participants during the presentation. There is a lot of group work facilitated by the trainers. Anonymized case studies from real life will be used for discussion and problem solving.


After the course, you will have a good understanding of:

  • Interpretation of the updated GCP requirements and how to implement them in practice with regards of risk-based approach and risk assessment


  • Corrective Action and Preventive Action


  • Risk-based audit and quality plan


  • Sponsor and investigator oversight


  • Handling of protocol deviation


  • Handling of source data


  • Essential requirements of EMA Trial Master File Guidance from Dec. 2018


Special features

Bring your own case studies that needs to be clarified

All delegates will receive comprehensive course documentation

Certificate of Attendance issued by the trainers

3-day Intensive Learning & Training

5H+ Practical Workshops & Discussions

6H+ Networking

Hands-on examples

Key takeaways

Be aware of important developments such as risk-based approaches to trial management and oversight

Develop GCP problem solving skills by considering the most common problems encountered in clinical trials, how to solve them and how to prevent recurrence

Have a complete understanding of different processes in clinical trial

Be aware of the most important rules relating to handling of clinical trial data

Understanding of trial master file requirements

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Delegate Fee

from 2496 € Buy

For registered participants only:

  • Note: the case will be anonymised and all information will be handled confidentially.


Based on your requirements, we will build a practical training including content tailored to your specific needs, our cutting edge methodologies and relevant modules from our training portfolio.

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