Consenting Patients with Confidence

CTO Research Ready Workshop

  • Date: March 26, 2019
  • Time: 10 am -4 pm
  • Location: MaRS Auditorium

About Research Ready 

Community driven training and mentorship program for research coordinators, research personnel and new investigators in Ontario.  Research Ready will leverage existing programs and material, including programs developed by Ontario centers, with the aim to enable the Ontario research ecosystem.

Research Ready will:

Training Mentorship
o   Connect people to existing training
o   Develop and deliver training when needed
o   Incorporate best practices
o   Focus on the Canadian environment
o   Reflect changes in the environment
o   Be designed to be SOCRA/ACRP credit worthy 
o   Facilitate sharing of best practices

o   Highlight exceptional processes
o   Connect mentors and mentees

 

Who should attend this Workshop?

This workshop is primarily intended for research coordinators who:

  • Are new to their role
  • Want to improve their current process and be confident in patient consent
  • Want to refresh their skills
  • Want to build their network

This workshop may also benefit clinical research personnel from industry and CROs who want to better understand the context in which research coordinators work.

The workshop will include presentations, breakout sessions and opportunities for people to work together on scenarios to help absorb new learnings.

Workshop Learning Goals

From this workshop, we will examine consenting patients in a modern, fast moving clinical trial environment with a strong emphasis on the patient-perspective,  regulations, privacy and legal aspects.

Have you ever asked: When can you start screening patients?  How do you re-consent when using e-consent? What consent documentation will you need in an audit? What it is like to be consented in a study?  If so, this workshop is for you.

In this workshop, you will learn how the regulations and other considerations apply to everyday trial processes (i.e. documentation, consent, communication).  You will also be introduced to the Research Ready platform and community networking opportunities.

Consenting Patients with Confidence- A Research Ready Workshop

   Agenda

Topic

Introduction to the Research Ready Platform
When can you start screening patients?  

  • What is the circle of care? When does research enter the circle?
  • Privacy considerations
  • Legal requirements
  • Pre-screening vs Screening vs Recruitment
  • Compliant steps to being enrollment ready
Ensuring patients are consented properly

  • Proper process and documentation
  • Audit ready considerations
  • Institution’s role, REB’s role, PI’s role
Secondary use of research data

  • Being clear on what the patient is consenting to
  • What approaches can be taken for this?
Upcoming changes in regulations and laws

  • Common rule: What is it; how does it affect consenting process; when does it need to be implemented
  • GDPR:  What is it; how does this impact patient consent; when do these changes need to be implemented
Different aspects of patient consent 

  • E-consent
  • Screening consent
  • Substudy consent forms
  • Re-consent
How to consent well

  • Seeing consent from the patient’s  perspective

 

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