RDF19 Poster Details

Introduction

Sponsorship is a risky and complex business.

Our introduction will be a welcome to delegates, personal introductions and outlining key learning objectives. 

What is risk?

Group discussion around experience in conducting risk assessments (sponsor or otherwise) to gauge experience and background. Delegates will be asked to consider their definition of risk. Responses will be discussed, collated and displayed.

Risk and clinical trials – Types of risk

Group discussion around why risk assessments are needed and the kind of risks that need to be considered in health research,
Delegates will split into teams based on different categories and asked to think about what kind of risks may need to be considered within each category. Categories as follows;

• IMP management
• The CI and investigator team
• Study design
• Patient safety
• Feasibility and patient recruitment
• Finance, funding and contracts
• Insurance and indemnity
• Study management arrangements

Risk management & mitigation 

Key risks relating to clinical trials will be discussed – Delegates will be asked to consider risk examples based on their previous group discussion, and asked to formulate their own risk mitigation considerations for each area. Responses will be presented and discussed by delegates.

Designing your risk assessment – An example

We will summarise and bring together what we’ve learned. We will show delegates an example of a completed risk assessment and discuss how it was developed, how it is used, and showcase functionality that can be easily adopted.

• COOKE, Benita (R&D Coordinator: The Christie NHS Foundation Trust)
• HERRON, Deanna (R&D Coordinator: The Christie NHS Foundation Trust)