Overview

This virtual live training course covers the essential concepts of EU and UK data protection laws that sponsors need to consider when running clinical trials.

Understanding and complying with data protection laws, such as the General Data Protection Regulation (GDPR), is crucial for clinical trial sponsors to ensure legal compliance, protect participant rights, maintain data security, and uphold ethical standards in clinical research. It is also often a prerequisite for obtaining regulatory approval to conduct the clinical trial.

This training course will equip participants with the knowledge and tools to navigate GDPR requirements confidently and ensure clinical trials meet the (sometimes) onerous GDPR requirements. Case studies will be used throughout to provide context.

Participants benefit from the hands-on experience of instructors who are experts in this area.

Featured topics

- GDPR Overview
- Lawful Processing of Study Subject Data
- Transparency
- Role of the Site
- Engaging vendors
- Cross-Border Transfers
- Investigators and Study Personnel
- Safety Data Reporting Activities
- Data Treatment Principles and Accountability
- Security and Personal Data Breaches

Who should attend?

This course is designed for professionals involved in Clinical Trials such as:
- Commercial and Non-commercial sponsors of clinical trials
- CROs
- Consultants

Learning objectives

At the conclusion of this virtual live training course, participants will be able to:
- Appreciate the national-level nuances when it comes to identifying the legal bases for processing and meeting the transparency requirements under the GDPR and learn how best to reflect these in the ICF/PIS to ensure (as far as possible) a streamlined approach to a multi-jurisdiction study
- Understand the implications for the potential differing roles of a site i.e., in different countries and how this is in turn reflected in the CTA and ICF/PIS
- Recognize key considerations and necessary contractual provisions when engaging CT vendors
- Be able to identify cross-border data flows, and the mechanisms to address including, the nuances in approach in clinical trials
- Understand what constitutes a personal data breach and the potential consequences for this under the GDPR
- Identify key actions for GDPR-compliant processing of study personnel data
- Learn how to meet data treatment and accountability requirements in clinical studies including, how to conduct a DPIA and the potential expectations of sites/ECs in relation to the same

Digital Learning Catalog

Download

Have an account?

Download registration form Register Now (Credit Card)

Mastering GDPR Compliance in Clinical Trials