Tailored for stakeholders with basic knowledge and experience in the field of GDPR Compliance or General Data Protection Compliance.
Educational Session / Workshop is focused on Clinical Research Environment.
Suggested participants: Clinical Trial Sponsors, Clinical Trial participating CROs, Freelance Clinical Research professionals.
Applicable Data Protection Regulation/Legislation: Extraterritorial Application of the GDPR, Local Specifics
Personal Data Protection Fundamentals: What is Personal Data, Examples, Pseudonymization vs Anonymization, Categories of Personal Data, Special Categories of Personal Data, Common misconception, Data Subjects in Clinical Research Environment
Processing Roles Allocation: Data Controller vs Data Processor, Responsibilities, Sponsor vs CRO vs Sites, Clinical Sites: Processors or Joint or Independent Controllers
Data Protection Officer vs EU GDPR Representative: Data Protection Representative vs Legal representative
Data Processing Principles
Legal Basis for Processing and Purpose: Consent vs Legitimate Interest in Clinical Research
Consent: Processing Consent vs Informed Consent Form, Personal Data Information Notices for Study Staff; Emergency Enrolment
Records of Processing Activities: Obligation to maintain RoPA; Responsibilities; Characteristics of RoPA
Data Breach Management: Personal Data Breach Management, Confidentiality Breach Management, Security Breach Management
Data Subject Requests Management
International Transfers: Appropriate Safeguards in Clinical Research Environment, List of Adequacy, New European Commission’s SCCs, Other Transfer mechanisms
Data Retention in Clinical Research
Data Processing Agreements with Third parties (CDAs, MSAs, CTAs, DPAs, DSAs)
Security of Data: Technical and Organizational Measures
Data Protection Training for Clinical Research Participants
Data Protection By Design: Accountability – Trial Set-Up