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
Pricing structure
- £299+VAT for 2 or more NHS or public sector places
- £399 + VAT for one NHS or public sector place
If you would like to make a group booking across more than one online course, you can. Email Sophie Richardson who will be able to assist you.
This course is available for in-house training
If you have a group of 30 or more members of staff who require this training, then why not commission your own on-site course? Please email Sarah Kemm or call 01732 897788 for further details.
Commercial companies are also invited to sponsor this day. Please email Sarah Kemm for further details.
You can reserve a no-obligation place whilst you apply for funding.
- Booking contact: name, job title, department, email and telephone number
- Event(s) to reserve for: title and date
- Delegate details (for each delegate): name, job title, department, email and telephone number
- Organisation details: name and address
Alternatively you can make a confirmed booking by emailing the above information to the bookings team.
Once you have booked your place, SBK Healthcare will correspond with you using the email address you provided at the time of booking. Within one week of the online training taking place, you will be sent final details of the course including a full agenda, programme timings and your Zoom joining instructions. This email will include a joining link that can be used to access the course.
If you have not received your email two days before your event, do check your junk folder then contact SBK Healthcare on 01732 897788.
Practice sessions are available. If you would like to attend a zoom practice session before the event takes place, please let us know by emailing bookings@sbk-healthcare.co.uk. You will have the opportunity to meet an SBK Healthcare staff member who will ensure you are able to access zoom, that your camera and microphone work and you are fully set-up for the day. This is optional but if you do wish to attend, please use the same device that you plan to use on the day.
On the day, when registration starts, you will be able to join the course by initially entering a waiting room when there may be a short wait. The forum will include screen breaks, as well as topic themed interactive sessions which will take place in the breakout rooms.
Click here to view the specially created 5-minute video that will walk you through how to get the most out of attending your SBK Healthcare interactive online forum.
Certification of attendance
A certificate for Continuing Professional Development will be given to every fully registered participant who completes the course, as a record of your continuing professional training and development.
Registration fees
You will be sent an instant payment option or invoice on registration. Your payment is required in advance. If your fee has not been received prior to the event, and you are not able to provide a PO or proof of payment, you will be asked to make a credit or debit card payment on the day.
Modify registration
To let us know if your details are not correct when you have already registered, please email the bookings team.
Cancellations and substitutions
A full refund of fees will be made only for cancellations received within the first 48 hours of the booking being made. Notice of cancellation must be received in writing by emailing the bookings team at SBK Healthcare. Should you need to cancel your registration after this date, the registration fee remains payable in its entirety although a substitution will be accepted and conference documentation will be provided. Substitution attendees for delegates unable to attend after registering are acceptable at any time.
Event changes
It may be necessary for reasons beyond the control of the conference organisers to alter the content, speakers or the timing of the programme. We will endeavor to keep you abreast of such changes but any unavoidable change to the format will not constitute a reason to refund the fee. Should the event be postponed, we will endeavor to reschedule the event. If, for reasons beyond the control of the conference organiser, the event is cancelled, a full refund will be made. We do not accept any liability for any incurred costs resulting from a postponement or cancellation.
Privacy notice
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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