GDPR Basics for Clinical Researchers

Description
Regulatory

Your organization does not need a DPO, but you want to appoint a internal data protection liaison to ensure compliance and internal data protection expertise? Then this course is for you, as it introduces GDPR, including knowledge and skills needed to ensure a proper understanding of the basics and how to apply both on an organizational level as well as for the conduct of clinical trials. Topics include definitions of personal data, scope, goal of collection, legal basis, subject rights, privacy statements, controller & processor and their responsibilities, need for a DPO and DPIA, amongst others.

We are offering this course in live online sessions, spread over a period of time to ensure ample time to cover all topics and have enough opportunity to ask questions and to discuss. The sessions will be designed in an interactive fashion for a productive and nice online experience.

Schedule live online sessions:

  • Theory (2 hours each) on Wednesday and Thursday between 10am-12pm CET:
    • 27/5: Intro to GDPR; personal data and data processing principles
    • 28/5: Roles in GDPR (controller, processor and third party) and contracts with processors
    • 3/6: Legal basis for personal data processing; processing of sensitive personal data
    • 4/6: ICF, privacy statement & protocol

 

  • Practice (1 hour each) on Thursday between 11am-12pm CET:
    • 11/6: Exercise- assignment explanations
    • 18/6: Discussion on exercise outcome
Learning objectives

By the end of this TRIUM Training you should be able to:

  • List important GDPR roles, related responsibilities and relevant definitions
  • Explain what documentation needs to be in place to provide evidence of compliance for controllers and processors
  • Describe the need of personal collection goals, correct choice of legal basis and consequent data subject rights and privacy statements
  • Critically assess when reporting of a data breach is required to the local data protection legal entity and related timelines
  • Tailor GDPR compliant ICF, protocol and contract templates to your specific trial needs
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Trainer
Esther Daemen
Esther Daemen is currently ‘Quality &Training Director – Data Protection manager’ at TRIUM Clinical Consulting and has over 27 years of working experience in the healthcare/pharma & device field. She served many organizations in different research roles and as professional development director at ACRP global. She gained a bachelor’s in nursing and earned project management, training and DPO certificates as well as and a master´s degree in Business. Esther is also a highly sought-after presenter at professional conferences/universities and a writer of peer-reviewed articles for professional magazines like ‘The Clinical Researcher’. Her work was rewarded by the KP Morgan 'OECT Summit 10Years Speaker Achievement Award' in 2020, the ‘Best trainer to watch’ 2010 Training Magazine award and by having her organization ‘Kendle’ being listed as one of the top 125 training providers in the world in 2008. "TRIUM is an expert Contract Research Organization that offers a unique combination of global CRO services, staffing solutions, quality services, GDPR consultancy and risk-based approaches as well as training services. It’s our mission to be a passionate, dedicated business partner with a focus on excellence to provide start‐to‐finish clinical trial activities tailored to the timing, budget and specific needs of the Sponsor.”