Enrolment will be open from 13th Nov – 11th Dec 2023



Title of Course: Remote &  Hybrid Paediatric Clinical Trials

Edition of the course: Pilot Edition

Course Duration: 1 day between 09:00-15:10 CET 

Course date: 14th Dec 2023

Course enrollment: Enrollment is open from 13th Nov to 11th Dec 2023


To enrol in this course, please contact your National Hub who will supply you with the course password.

Your National Hub’s Referent Person for Training and Education will verify your eligibility to enroll to the Course and provide you with the Course’s enrolment password.

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General Description:

Many patients have physical or logistical difficulties in reaching the hospital to receive therapy. Thanks to recent technological and pharmacological advances, today evaluations can be performed in a remote fashion and therapy can also be administered at home. However, to ensure the highest research and care standards, even in home settings, and to minimize impact of potential adverse events, healthcare personnel need to be trained appropriately on how to conduct a remote clinical trial and manage adverse reactions to therapies. This course will provide a theoretical and practical opportunity to learn how to set-up and perform a remote and hybrid clinical trial and how to manage emergency situations that may arise during home therapy.


Objectives for course:

  • Enhance knowledge on particularities of remote clinical trials and improve the preparation and awareness of medical and paramedical professionals about home therapies using high-tech simulation tools;

  • Create a new class of health professional that are able to provide appropriate home care to patients in case of emergency situations;

  • Improve the safety and quality of care for patients.


Programme:

This course will be delivered live via Zoom on the 14th December:

  • 09:00 – 09:30 Context of acceleration of remote and hybrid trials

  • 09:30 – 10:00 Organizational aspects of remote and hybrid clinical trials: designing and setting up the trial

  • 10:30 – 11:00 Assent and consent

  • 11:00 – 11:30 Organizational aspects of remote and hybrid clinical trials in C&A: developing the trial (trainings, adaptations for reliable data collection, gamification)

  • 11:30 – 12:00 Ethics behind decentralized paediatric trials (interactive discussion)

12:00 – 13:00 LUNCH

  • 13:00 – 13:30 Importance of simulation and management of adverse events and emergencies during home therapy and remote and hybrid clinical trials

  • 13:30 – 14:00 Paediatric drug safety in remote clinical trials – an introduction

14:00 – 14:10 BREAK

  • 14:10 – 14:30 Patient perspective

  • 14:30 – 14:50 Discussion about pros and cons of decentralized clinical trials

  • 14:50 – 15:10 Q&A and close


Who is the course for?

The course is aimed Clinical trial nurses, medical doctors involved in clinical trials, paramedics.


Max. number of persons that each national hub can enrol:
Unrestricted


Bloom’s taxonomy level of the course:

Certification

On completion of satifisication questionnaire, you will receive a certificate of attendance.


Faculty:

  • Carmen Moreno

  • Janelle Burnham

  • Maurizio Scarpa

  • Aneta Woroniecka-Osio

  • Pamela Dicks

  • Zorica Živković

  • Segolene Gaillard

  • Beate Aurich