Preparing for an Inspection in Clinical Research

Preparing for an Inspection in Clinical Research
Online Course, 5 CPD hours
Tue 30 Jun 2026 09:30-15:40

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. 

What will you put into practice?

Plan and prepare for inspections and audits so that you are always ready

By offering practical advice to you and your NHS clinical research team, this interactive training 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

Join this NHS online course 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 course with the confidence to make changes

In-house training

Available as bespoke training to teams of 30+ 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.

Learning & development

Oncology National Networking Forums are pleased to be featured as part of the ACCEND Framework

The ePortfolio platform is available via the Greater Manchester Cancer Academy and supports professional development in cancer care.

This forum and all of our events are mapped to the ACCEND Framework and can be recorded in the ACCEND ePortfolio to help you evidence your learning, reflections and competencies.

To find out more, click on the ACCEND tab.

9:30
Join, technical support and instructions
10:00
Introductions and 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”. Karl will share his top tips and first-hand experiences, so that by the end of the course 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

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 online courses:

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"Overall, I found the Clinical Research Leadership and Management course to be highly informative and enriching. It provided comprehensive coverage of a wide range of essential topics within the field, including both the theoretical foundations and practical applications of leadership in clinical research settings. The course also offered valuable insights into various leadership styles and approaches, allowing me to explore and appreciate multiple perspectives on effective management. Through its structured content and diverse viewpoints, the course significantly enhanced my understanding of what it means to lead successfully in the context of clinical research"
- Royal Papworth NHS Foundation Trust, Clinical Research Leadership and Management, June 2025
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“Very clear and concise in his presentation. Engaging and informative”
- The Princess Alexandra Hospital NHS Trust, Advancing your Clinical Research Practitioner Role, September 2024
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"Very engaging and relevant content. The timetable worked very well with bite-sized sessions interspersed with breaks"
- The Princess Alexandra NHS Trust, Clinical Research Leadership and Management, July 2023
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"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
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“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
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“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
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“Brilliant experience, friendly setting where ideas are encouraged and welcomed”
- Sheffield Teaching Hospitals NHS Foundation Trust, Clinical Research Leadership and Management 2021
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“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

About the ACCEND Framework

The ACCEND Framework is designed to enhance cancer care by providing a structured approach to education and professional development for healthcare professionals.

  • It defines the essential Cancer Capabilities in Practice (CiPs) and offers a tailored educational structure to support progression at every stage of a cancer care career.
  • Launched in January 2023, the framework aims to transform career pathways and improve training and development opportunities across the cancer workforce.
  • It provides access to the education and training needed to meet role-specific competencies and includes dedicated resources for nurses, allied health professionals and those in cancer-related support roles.
  • The ACCEND Framework delivers a nationally agreed career and education structure underpinned by clearly defined capabilities in practice.

Map your learning

All Oncology National Networking Forum courses listed on the Greater Manchester Cancer Academy’s ACCEND ePortfolio are fully aligned with the ACCEND Framework.

You can easily log your attendance and map your learning to the Cancer Capabilities in Practice (CiPs) through the ACCEND ePortfolio.

To do this:

  • Register and log in to the ePortfolio
  • Click ‘Add Entry’
  • Select 'Choose an item from the library'
  • Change the provider to Oncology National Networking Forums
  • Choose the relevant event you have attended (or plan to attend)

This tool offers a central space to track your professional development, reflections and achievements - supporting your ongoing career in cancer care.

Click here to access the ePortfolio


Sponsorship engagement

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.

Your 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: 

Vanessa Pearce
Contact: 01732 897788 
Email: vanessa.pearce@sbk-healthcare.co.uk