Interactive forums Face-to-face Clinical research
Wed 12 Jun 2024 09:30-15:40
Holiday Inn London Bloomsbury

By offering practical advice to NHS clinical research teams, this forum will offer concrete support in improving Quality Assurance (QA) and preparing for a regulatory inspection/audit. Featuring evidenced based examples, interactive presentations, closed room discussions and an agreed action plan.

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Preparing for a Clinical Research Inspection, London
London 4.5 hours From £349+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 face-to-face event 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

Invitation to sponsor

SBK Healthcare National Conferences are designed to enable clinical research providers to support healthcare professionals. If you would like to sponsor this forum, please email Sarah Kemm or call Sarah on 01732 897788 to find out about all the engagement and branding opportunities available in the full sponsorship package.

9:30
Registration and networking opportunity
10:00
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
10:10
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
10:40
Questions, answers and discussion
10:50
Interactive discussion: Navigating where and why problems can occur in clinical research
  • Where do you think problems can arise?
11:20
Refreshment break
What does good look like?
11:30
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
11:50
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
12:10
Questions, answers and discussion
12:30
Lunch break
Getting ready for an inspection/audit
1:00
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
1:40
Questions, answers and discussion
1:50
Interactive discussion: How to overcome the challenges
  • What measures can be taken to reduce error in clinical research/trials?
2:20
Refreshment break
2:30
Common question and answers, problems and findings from clinical research practice
2:40
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?
3:00
Always being Inspection and Audit Ready
  • Culture of continuous improvement: internal audit and team learning
  • Practical Q&A
  • Facilitating oversight
3:20
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?
3:40
Closing remarks and close of day

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”. At this live and in-person event, Karl will share his top tips and first-hand experiences, so that by the end of the day you will be on top of your audit and inspection game.

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

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

  • £499 + VAT for one NHS or public sector place
  • £399 + VAT (each) for two or more NHS or public sector places
  • £349 + 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 £399+VAT and £349+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.

Venue details

Venue name: Holiday Inn London Bloomsbury

Address: Coram Street, London WC1N 1HT

Tel: 0871 942 9222

Email: reservations@hibloomsbury.co.uk

Holiday Inn London Bloomsbury is situated near Russell Square Tube station on the Piccadilly Line, and is close to major transport hubs such as Kings Cross St Pancras station and Euston station, both of which are less than a mile away and reachable in five minutes by bus or taxi. You can also drive to Heathrow Airport (LHR) in 40 minutes.

Directions: Click here to plan your journey using Google Maps

Accommodation suggestions: You can book your bedroom directly with the hotel using the above contact details (SBK Healthcare does not facilitate accommodation bookings). The venue is centrally located and there are a number of alternative places to stay. Availability for alternative accommodation can be identified by searching online, for example www.trivago.co.uk or www.uk.hotels.com and inputting the address and date of your visit.

Reservations

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 

Terms and conditions

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 face-to-face conference 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 events:

"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.

Why sponsor a Clinical Research Forum

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 clinical research forums offer dedicated presentation, 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

Email: sarah.kemm@sbk-healthcare.co.uk