Decentralised Clinical Trials – From Theory to Practice
Book a session
Date | Product | Location | Price | |
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No sessions planned as this time, however if you are interested in taking this course please contact us at info@eccrt.com |
About this course
Reasons to attend
Pharmaceutical companies are continuously exploring new patient-centric opportunities to improve efficiency in clinical development, better engage with clinical trial participants, and reduce development costs and timelines.
This programme will be a learning journey, where the attendees will not only learn from the expert trainers but where the aim will be that the entire cohort forms a community and grows together. There will be case studies and practical workshops to pull everyone out of their comfort zone and to find best practices together.
Representatives of study participants, investigational sites, industry, regulatory agencies, and vendors will moderate the different events within the journey. This will ensure that every stakeholder involved in decentralised trials is involved in the programme for a holistic view of the process.
The course provides a mixture of presentations, discussions and practical exercises aimed at providing you with a practical understanding of the new technology and digital channels and how they can facilitate decentralised trials.
What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course schedule
Course Description
Remote or decentralised trials offer tremendous benefits to sponsors, patients, investigators, nurses and service providers. We will be taking a deep dive into patient-centric decentralised trial conduct and explore how these trials and modern technology offer new opportunities for all involved and interested in patient-centric strategies.
Traditional clinical trial burdens, such as inconvenient site locations, logistical concerns, time, and financial constraints, and missed visits may result in patient dropouts and increase non-compliance. Creating a decentralised trial setting and utilising smart devices and new technology can help reduce these burdens and enable patients to take part in clinical trials remotely and give them access to the treatment they may not have otherwise.
In addition to providing you with the basics of decentralised trials, this course will also provide insights on the regulatory landscape regarding, e.g. Home Nursing, Direct-to-patient IMP shipment and e-informed consent and much more.
In other words: this will bring theory into practice!
Programme highlight
- Theme 1 - Introduction into Decentralised Trials
- Theme 2 - The regulatory situation surrounding Decentralised Trials
- Theme 3 - Patient visits at home including safety monitoring
- Theme 4 - Investigational Product Management
- Theme 5 - Regulatory Compliance
Learning objectives
- Become familiar with the current regulatory requirements related to decentralised trials
- Gain a deeper understanding of what authorities expect regarding decentralised trials
- Understand the importance of adapting the trial setting
- Understand necessary updates of role profiles, relevant trainings, and communication
- Share best practices to conduct decentralised trials
- Build consensus on hurdles encountered when doing decentralised trials.
Who should attend
This training is an excellent opportunity for people working in areas such:
- Clinical Trial Management
- Clinical Innovation Teams
- Regulators, Health agencies driving innovation
- Investigational Sites and Patient Service Centers
- Home Nurses involved in clinical trials
- Drug Supply and Shipment Logistics staff
- Medical Device and modern data collection technology providers and users
- Clinical trial support staff
- CRAs, Nurses and Physicians
- Patient Advocacy Groups and patients
- Other healthcare industry roles interested in patient-centric strategies and decentralised trials
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (2)
- Ethical & Participants Safety Considerations (2)
- Investigational Product Development and Regulation (1)
- Clinical Studies Operations (GCPs or ISO 14155) (6)
- Study and Site Management (4)
- Data Management and Informatics (5)
- Leadership and Professionalism (2)
- Communication (1)
- Teamwork (1)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained
Soenen Rani
UZ Gent
Gabriela Stanescu
Chiesi