Sandrine Verstraete
With over 25 years of experience in clinical research—including more than 20 years as an independent consultant—I offer a comprehensive and strategic perspective on the operational, regulatory, and scientific dimensions of clinical trial execution. Since beginning my career in 1998, I have worked across a wide range of therapeutic areas, study phases, and trial types, including investigational medicinal products (IMPs), medical devices, and non-interventional studies (NIS).
I have held both global and regional roles, including responsibilities as a Clinical Trials Regulation (CTR) expert and Global SIP (Standard Investigational Processes) Adoption Lead, driving implementation strategies across international teams. On the regional level, I have served as a CRA, Lead CRA, and Project Manager, with direct involvement in site operations, feasibility, recruitment, auditing, CAPA resolution, and team leadership.
Since 2012, I have been delivering ICH GCP E6 training—initially based on R1 and subsequently revised versions R2 and R3—to both investigator site personnel and sponsor staff at affiliate level. I also provide CRA coaching to enhance performance, foster compliance, and support professional development.
As a trained psychologist, I am deeply engaged in understanding human behavior and cross-cultural dynamics—particularly how these impact collaboration and communication within global clinical teams. I am passionate about translating complex regulatory and operational topics into accessible, actionable insights. My focus remains on delivering value through pragmatic execution, continuous process optimization, and a collaborative mindset.
Description:
This comprehensive training course dives into the latest updates of ICH GCP E6(R3) guideline. It is designed to equip clinical research professionals with the knowledge and skills necessary to ensure compliance with contemporary ethical and scientific quality standards in clinical trials.
Why Attend this Training:
Stay Current: Understand the significant revisions from E6(R2) to E6(R3), including enhanced principles focusing on participant protection, data integrity, and risk-based quality management.
Enhance Compliance: Gain insights into the updated roles and responsibilities of sponsors, investigators, and ethics committees to ensure adherence to regulatory requirements.
Professional Development: Earn a recognized certification upon completion, demonstrating your commitment to maintaining high standards in clinical research.
Who this course is for?
This course is ideally suited for both freelance and employed clinical research associates, regional project managers, regulatory affairs professionals within pharmaceutical companies or CROs, site staff, and all individuals involved in the planning, execution, or oversight of clinical trials who aim to stay aligned with the latest ICH GCP standards.
Earn a Certificate
When you finish listening to all videos, quizzes and practice exams, you'll earn a Certificate that you can share with prospective employers and your professional network.
This course includes:
● 2 hours on-demand video
● Interactive modules covering key aspects of E6(R3)
● Case studies illustrating practical application
● Quizzes to assess understanding
● Full lifetime access
● Access on mobile devices
● Certificate of completion
Course Curriculum
- Do we need to update SOPs or QMS to reflect R3? (2:40)
- How does R3 apply to trials already running under R2? (1:53)
- Based on the R3 changes, there are changes on the CTIS process? (1:01)
- What is the first step to implement in order to become more compliant with R3? (1:50)
- What about service provider? (2:03)
FAQ
What do I get when I purchase the course?
By purchasing the course, you will receive full access to the video course. You can watch the content at your own pace and according to your availability.
Is the TransCelerate certificate only available to those who complete the course in a specific way?
No. As long as you watch the course and successfully complete the final quiz, you will be eligible to receive the TransCelerate certificate.
We are a group of people interested in joining the course. Are there any discounts available?
For groups of 5 or more participants, please contact us at [email protected] for a quotation.
Is this training only intended for clinical trial site staff?
No. Even if the certificate issued complies with the TransCelerate minimum criteria for ICH E6 (R3) GCP Investigator Site Personnel Training, the course is also suitable for members of CROs, Pharmaceutical Companies, and freelancers.