Preparing for a Clinical Research Inspection

Preparing for a Clinical Research Inspection
Online £399+VAT 4.5 Hours
Online Course
Thu 11 Jul 2024 09:30-15:40

By offering practical advice to NHS clinical research teams, this course will offer concrete support in improving Quality Assurance (QA) and preparing for a regulatory inspection/audit. Participants can expect evidenced based examples, interactive sessions, focused discussions and an agreed action plan.

Ensure proper planning and preparation 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 online 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 Events 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
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
  • 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
Screen 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 time screen break
Getting ready for an inspection/audit
12:40
Interactive discussion: where do you think problems can arise?
  • What measures can be taken to reduce error in trials?
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
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
  • 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

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 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

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

  • £399 + VAT (each) for one NHS or public sector place
  • Group Discount - 4 places for the price of 3

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.

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 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

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 course 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 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:

quote icon
"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
quote icon
“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
quote icon
“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
quote icon
“Brilliant experience, friendly setting where ideas are encouraged and welcomed”
- Sheffield Teaching Hospitals NHS Foundation Trust, Clinical Research Leadership and Management 2021
quote icon
“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

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 

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