By offering practical advice to NHS clinical research teams, this course offered concrete support in improving Quality Assurance (QA) and preparing for a regulatory inspection/audit. Participants were provided with evidenced based examples, interactive sessions, focused discussions and ended the day with an agreed action plan.
Improving Quality Assurance (QA) and preparing for a regulatory inspection/audit in your clinical research team
Key learning outcomes:
- Recap on Good Clinical Practice (GCP) and understand related regulations, legislation and policy
- Navigate the different inspection and audit processes
- Learn how you can effectively prepare for inspections/audits
- Be guided through common challenges, problems and how to overcome them
- Build an action plan to improve QA in your team
| 9:30 |
Join, technical support and instructions
|
| 10:00 |
Chair’s opening remarks
Karl Ward, Lead Nurse for Research and Innovation (Education), Leeds Teaching Hospitals NHS Trust, Lead for the LTHT Research Academy, NIHR GCP Facilitator and Fellow, Higher Education Academy
|
| Introduction: Exploring the Basics | |
| 10:10 |
Recap on Good Clinical Practice (GCP) and related legislation
|
| 10:40 |
Questions, answers and discussion
|
| 10:50 |
Interactive discussion: Navigating where and why problems can occur in clinical research
|
| 11:20 |
Screen break
|
| What does good look like? | |
| 11:30 |
Overview of Quality Assurance (QA) in clinical research
|
| 11:50 |
Preparing for regulatory inspection and/or sponsor audits
|
| 12:10 |
Questions, answers and discussion
|
| 12:30 |
Lunch time screen break
|
| Getting ready for an inspection/audit | |
| 12:40 |
Interactive discussion: where do you think problems can arise?
|
| 1:00 |
How to effectively prepare for an inspection or audit
|
| 1:40 |
Questions, answers and discussion
|
| 1:50 |
Interactive discussion: How to overcome the challenges
|
| 2:20 |
Screen break
|
| 2:30 |
Common question and answers, problems and findings from clinical research practice
|
| 2:40 |
Preparing for an interview with an inspector/auditor
|
| 3:00 |
Always being Inspection and Audit Ready
|
| 3:20 |
Building an action plan: Planning and preparing for the inspection/audit: future planning
|
| 3:40 |
Closing remarks and close of day
|
Bringing a wealth of expertise and knowledge
Karl has been described as having “a versatile knowledge on research” with an established reputation for providing online courses which are “efficient and accessible, with an intuitive format”. At this online event, Karl shared his top tips and first-hand experiences, so that by the end of the day participants were on top of their audit and inspection game.
Karl Ward
Lead Nurse for Research and Innovation (Education)
Leeds Teaching Hospitals NHS Trust, Lead for the LTHT Research Academy, NIHR GCP Facilitator and Fellow, Higher Education Academy
Who came?
This course was developed to advance your team’s quality assurance ahead of inspections and audits and was attended by Network and Academic Clinical Research Teams including:
- Principle Investigators
- Heads and Directors of Research
- RM&G and Research and Development Managers
- Trial Co-ordinators, Facilitators and Managers
- Clinical Research Nurses, Midwives and Practitioners
If you have a team that is 30 people or more, you can have a bespoke workshop delivered online to your team alone. Please contact Sarah Kemm or telephone 01732 897788.
Past attendee feedback
Don’t take our word for how much the attendees enjoy our training, look at the feedback from our previous clinical research events:
Why sponsor?
Our role at SBK Healthcare is to bring industry together with healthcare professionals so that you can educate and inform your audience. These trail-blazing oncology forums offer dedicated presentations, Q&A, networking and discussion time, each sponsor will be fully immersed into the event and able to effectively engage with your NHS audience.
Interested in having your own event, managed by us?
SBK Healthcare also provides in-house forums. Working closely with you as the client we can research, produce, market and deliver the conference or online forum that best suits the audience and meets your goals.
Reach out today
If you would like more information on our sponsorship options an in-house forum or if you wish to discuss your needs and what solutions may be appropriate for your business, please contact:
Sarah Kemm
Contact: 01732 897788