Tue 27 Feb 2024 09:30-15:40
Online Workshop

*** Black Friday Deal *** Book your full price NHS or Public Sector place before Friday 8th December and get one third off! 

Come together with your clinical research team to ensure you are equipped to meet the legal requirements of Good Clinical Practice and are prepared for all inspections and audits in your clinical research service. You will leave this online course armed with all the knowledge you need to ensure you are always inspection and audit ready by embedding a culture of quality assurance into everyday practice. 

Other events of interest:

Preparing for an Inspection in Clinical Research
Online 4.5 hours From £249+VAT

Plan and prepare for inspections and audits so that you are always ready: what will you put into practice?

By offering practical advice to you and your NHS clinical research team, this interactive workshop will support you in improving Quality Assurance (QA) and preparing for a regulatory inspection/audit in your clinical research team. Book your place to:

  • 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

Developed with convenience in mind: join this NHS online workshop remotely

Take away useful techniques and new skills to use in your day-to-day role:

  • Evidenced based examples and referrals: providing appropriate, relevant support and sign posting
  • Interactive presentations: your concerns addressed with sensitivity and care
  • Closed room discussions: benchmark and engage with your fellow attendees
  • Agreed action plan: leave the workshop with the confidence to make changes

This course is available for in-house training

Available as a bespoke workshop to teams of 40+ people. Please do contact us if you would like this course delivered exclusively to your team, with the content developed to drill into the specific needs of your service. Please email Sarah Kemm or call 01732 897788 for further details.

Join, technical support and instructions
Introductions and opening remarks
Karl Ward, Lead Nurse for Research and Innovation (Education), NIHR GCP Facilitator, Expert Ethics Committee Member, Leeds Teaching Hospitals NHS Trust / National Institute for Health Research
Introduction: Exploring the Basics
Recap on Good Clinical Practice (GCP) and related legislation
  • Regulation, legislation and policy
  • The United Kingdom (UK) national picture
  • Common GCP inspection findings
  • Why your organisation is being selected?
  • Who is conducting the inspection/audit: understanding the processes
Questions, answers and discussion
Interactive discussion: Navigating where and why problems can occur in clinical research
  • Where do you think problems can arise?
Screen break
What does good look like?
Overview of Quality Assurance (QA) in clinical research
  • What does “good” look like in clinical research
  • Exploring the types of monitoring, audit and inspection
  • Understanding sponsor, site and staff responsibilities
Preparing for regulatory inspection and/or sponsor audits
  • Navigating different inspections/audits: MHRA, EMA, FDA, regulatory inspections and sponsor audits
  • Understanding risk-based inspections
  • Exploring the types of Findings
  • Pre-emptive Corrective and Preventative Action (CAPA): Preparation is key
Questions, answers and discussion
Lunch break
Getting ready for an inspection/audit
How to effectively prepare for an inspection or audit
  • Managing the Trial Master File / Investigator Site File
  • Delegation of duties
  • CAPA
  • Use of file notes
  • Source Data, Documentation and Case Report Forms (CRFs)
  • Oversight
  • Training and education
  • Sponsor / Contract Research Organisation (CRO) communication
  • Key Service Support (KSS) Departments
Questions, answers and discussion
Interactive discussion: How to overcome the challenges
  • What measures can be taken to reduce error in clinical research/trials?
Screen break
Common question and answers, problems and findings from clinical research practice
Preparing for an interview with an inspector/auditor
  • Practical tips
  • Do’s and don’ts
  • Possible types of questions you may be asked
  • What do I need to know?
Always being Inspection and Audit Ready
  • Culture of continuous improvement: internal audit and team learning
  • Practical Q&A
  • Facilitating oversight
Building an action plan: Planning and preparing for the inspection/audit: future planning
  • What will you take away from today that you can implement in your role and wider team?
Workshop leader’s closing remarks and close

Share in first-hand experience

Karl has been described as having “a versatile knowledge on research” with an established reputation for providing online workshops which are “efficient and accessible, with an intuitive format”. Karl will share his top tips and first-hand experiences, so that by the end of the workshop you will be on top of your audit and inspection game.

Job Title:
Lead Nurse for Research and Innovation (Education), NIHR GCP Facilitator, Expert Ethics Committee Member
Leeds Teaching Hospitals NHS Trust / National Institute for Health Research

Karl is a Lead Nurse for Research and Innovation (Education) at Leeds Teaching Hospitals NHS Trust (LTHT). He works within R & I to support clinical research delivery throughout LTHT. He has extensive clinical, educational, research and leadership experience. 

Karl is currently responsible for education and training for all staff involved in Research delivery and is the lead for the LTHT Research Academy. He acts as a source of expert advice in regulatory, governance and feasibility issues within the units he supports and the wider trust. Within the trust he has successfully developed, delivered and evaluated the package of training that is offered via the LTHT Research Academy. He is also a National Institute for Health Research (NIHR) accredited Good Clinical Practice (GCP) facilitator and delivers educational sessions on GCP, research governance, informed consent and investigator oversight to all grades of research delivery staff at a local and regional level. 

Until recently he was an expert committee member of a local Health Research Authority Research Ethics Committee and has served on national committees and steering groups for the Royal College of Nursing Research Society and is a current member of the Association of UK Lead Research Nurses (AUKLRN).

Pricing Structure

  • *** Black Friday Deal *** £266 + VAT until Friday 8th December
  • £399 + VAT for one NHS or public sector place
  • £249 + VAT (each) for groups of 20 or more NHS or public sector places

If you would like to make a group booking across the online courses, you can. You or your colleagues can claim the £299+VAT and £249+VAT NHS discounts, for booking two or more places across this and any other subsequent event, providing the same pricing structure applies. Click here to view the full list of up and coming events.

This course is available for in-house training 

If you have a group of 40 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

If your funding has not yet been secured or you would like to hold your place with no obligation whilst waiting for your study leave to be approved, you can reserve your place with us. Please email the reservations team at SBK Healthcare with your details:

  • 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 conference 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 conference.

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 and you will be sent an invitation to join one of our delegate practice sessions. These are optional but great if you are unsure of whether your camera and microphone will work on Zoom. We hold several one hour practice sessions across the week when a member of SBK Healthcare staff will be waiting in Zoom to assist you. Please do pop in, say hello and make sure you are all set for the day.

On the day, when registration starts, you will be able to join the conference by initially entering a waiting room when there may be a short wait. In groups of between 6-10 people, you will be admitted into the main conference room to be greeted by a member of SBK staff. In the same group you will be taken into a breakout room and asked to turn on your video and microphone. A member of the SBK team will get your group started with some orientation tasks and ‘ice breaker’ topics, before leaving you to network.

When you are automatically brought back into the conference room for the start of the conference, you will be asked to turn off your camera and microphone so that the chair can start the forum. During each presentation you will be able to ask questions in the chat box function. 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 a 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 endeavour 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 endeavour 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

To view the details on how your data is being collected and used, please view our Privacy policy

Expected attendees

Developed to advance your team’s quality assurance ahead of inspections and audits, this online workshop will be 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 20 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 online workshops:

"Delivered very well. I learnt a lot of stuff that I will be implementing in my work area. Thanks”

East Suffolk and North Essex NHS Foundation Trust, Clinical Research Leadership and Management 2022

“Very good speaker, content and structure. Liked the breakout groups and use of personal experience and examples”

Royal Papworth Hospital NHS Foundation Trust, Clinical Research Leadership and Management 2022

“The course was efficient and the topics were presented in an accessible, intuitive format which made it easy to stay engaged. The course was informative and inspires to reflect on my own practice as much as on the practice of the whole R&D team on every level”

Devon Partnership NHS Trust, Clinical Research Leadership and Management 2022

“Brilliant experience, friendly setting where ideas are encouraged and welcomed”

Sheffield Teaching Hospitals NHS Foundation Trust, Clinical Research Leadership and Management 2021

“Really good, informative course with really good interactive sessions. Best leadership course I have attended yet as specific to my role in research”

The Princess Alexandra Hospital NHS Trust, Clinical Research Leadership and Management 2021

View further comments on SBK Healthcare events on Trust Pilot.

An online forum like no other…

A live event that will feature leading presentations, interactive breakout rooms, and compelling Q&A discussions

As a sponsor you will have the opportunity to present your product or service, be a ‘face’ of the event and meet your audience face-to-face to discuss their experiences, interests and key concerns.

To find out more about sponsorship contact Sarah Kemm on 01732 897788 or you can email Sarah. Your organisation could be sponsoring this forum today!

Branding, marketing and education opportunities include...

  • Your organisation featuring on this forum website as ‘sponsored by’; including your logo, promotional text and links to your URL
  • 5 minutes presentation time during the main conference and taking part in the related speaker Q&A
  • Unique opportunity for the sponsored presenter to moderate one of the interactive breakout rooms
  • Additional company representatives can attend the online conference and meet the attendees during the interactive sessions in the breakout rooms
  • Your logo or company name will be included in all correspondence we send to registrations and all promotional emails sent out when marketing
  • Your support and sponsorship will be recognised when you are thanked at the opening and closing of the online forum as well as your logo featuring on the opening and closing slides
  • All sponsors will receive a copy of the registration and attendee list
  • Plus: a one-off option to add your question to the registration form, asking if attendees would like to share their email address with you so you can keep them informed after the online forum

Sponsor this forum and be part of a quality interactive event...

But don't take our word for it. We have had some excellent feedback from attendees to the forums that have been held to date:

"Forum was managed extremely well, and very professional"

IAPT National Networking Online Forum 2021 - 21st January 2021

“I am sure like everyone else I was apprehensive with going online, not sure how we could network, the ability for all participant's to participate and the quality of the presentations - all my fears were diminished this turned in to be a great day, networking, leading and sharing still occurred and links still formed. The presentations were excellent and the quality of the forum and set up great and so easy to follow and timing excellent.”

Reduce Paediatric Emergency Attendance Online Conference – 8th October 2020

“The conference has been far more engaging than in a conference centre. This I think is because of the ability to participate in chat throughout and the use of the breakout discussions.” “Excellent day! Organisation was great - loved the break out rooms for chat. Virtual chat added another really useful way to interact during the day, which isn't available to us at the physical conferences.”

Leading Change in Clinical Coding Online Conference - 11th September 2020

"Very informative, lots of opportunity for discussions and very well organised virtually"

Providing Support for Children on Long Term Ventilation - Tuesday 9th March 2021

"I enjoyed the group chats networking listening to others experiences, I also like that there was a lead on each group so the chats were influenced and no awkward silences that can occur on web meets. I thought the larger talks were really good and easy to listen to."

Modernising Outpatient Services Online Conference – 16th September 2020

“This is my first experience of an online conference and thoroughly enjoyed it. Wasn't sure what to expect. Would recommend to colleagues to attend future events” “This has to be the best online conference I have been to, I really enjoyed the breakout rooms.”

Advancing Ulcer Care Management Online Forum – 29th September 2020

View further comments on SBK Healthcare events on Trust Pilot.