A practical guide to ethical and scientific quality standards in clinical research

This full-day workshop is designed to provide an introduction to Good Clinical Practice (GCP), the EU Directives, UK Regulations and Research Governance Framework requirements covering clinical trials and other NIHR Portfolio studies conducted within Secondary Care (primarily hospital based) settings.

More information about our programme of GCP courses, including a more detailed description of the course, can be found on the NIHR website.

CRN North West London provides this course to the following:

  • Central & North West London NHS Foundation Trust
  • Central London Community Healthcare NHS Trust
  • Chelsea & Westminster Hospital NHS Foundation Trust
  • Imperial College Healthcare NHS Trust
  • London North West University Healthcare NHS Trust
  • Royal Brompton & Harefield NHS Foundation Trust
  • The Hillingdon Hospitals NHS Foundation Trust
  • West London Mental Health NHS Trust

If the trust you are associated with is not listed above, this means that you are covered by a different CRN team and you will need to contact them about training.  You can obtain contact details from the NIHR website.

If you have any queries about the NW London sessions, please email crnnwlondon@nihr.ac.uk.


A practical guide to ethical and scientific quality standards in clinical research for experienced research delivery staff

This GCP Refresher workshop is for experienced research delivery staff who:

have previously completed either taught or on-line Good Clinical Practice (GCP) training 

have recent practical experience of working in a clinical research environment 

and have a good understanding of the principles and quality standards of GCP and related frameworks. 

More information about our programme of GCP courses can be found on the NIHR website.

CRN North West London provides this course to the following:

  • Central & North West London NHS Foundation Trust
  • Central London Community Healthcare NHS Trust
  • Chelsea & Westminster Hospital NHS Foundation Trust
  • Imperial College Healthcare NHS Trust
  • London North West University Healthcare NHS Trust
  • Royal Brompton & Harefield NHS Foundation Trust
  • The Hillingdon Hospitals NHS Foundation Trust
  • West London Mental Health NHS Trust

If the trust you are associated with is not listed above, this means that you are covered by a different CRN team and you will need to contact them about training.  You can obtain contact details from the NIHR website.

If you have any queries about the NW London sessions, please email crnnwlondon@nihr.ac.uk.


The aim of this programme is to provide a comprehensive discussion of the factors involved in delivering clinical research.

Who is it for?

All members of staff who have been involved in clinical research for a minimum of 6 months.

By the end of the programme delegates will be able to:

  • Describe the basic research terms, types and designs;
  • Discuss the key events which have contributed to the development of legislation and principles of research which we currently work with;
  • Describe the role of the clinical research practitioner and discuss the application of the principles of Compassion in Practice;
  • Examine the roles and responsibilities of the members in a research team;
  • Consider the principles of the valid informed consent process;
  • Explore strategies concerning effective recruitment and retention of participants onto research studies;
  • Identify the components of a research protocol and the needs for feasibility;
  • Discuss the documentation requirements throughout the life of a study;
  • Highlight the issues related to study monitoring and auditing to ensure full compliance with the study protocol and in accordance with the applicable local regulations;
  • Explore issues related to drug development and safety reporting.

Programme outline

Day 1

  • Introductions, programme outline
  • The basics & history of clinical research
  • Participant advocacy & Compassion in Practice
  • The role of the clinical research practitioner
  • Roles, responsibilities & reflections of the research team
  • An overview of patient consent
  • Recruitment & retention of participants into clinical trials

Day 2

  • Feasibility & protocol review
  • Study management & documentation
  • Monitoring, audits & MHRA inspection
  • Drug & medical device development
  • Summary quiz, action plans and programme review



Great clinical research studies depend on great Principal Investigators!

In this 2 hour workshop, we will explore:

- The Principal Investigator's (PI's) responsibilities in leading the conduct of a study at a research site
- What makes an effective PI and the importance of effective leadership in study identification, setup, recruitment and conduct
- The skills and behaviours required to be an effective PI
- How and where to access support

This workshop which has been designed to enable you to embed the core principles of valid informed consent into your daily practice and to provide a foundation upon which to build competence in the valid informed consent process in your own research setting. The course covers the ethical and legislative frameworks that underpin the research consent process, along with the principles and responsibilities of consent in clinical research, best practice and insight into the added protection required for vulnerable groups.

Expected learning outcomes:
Delegates will have a demonstrable understanding of the background and practical implications of the valid informed consent process, and the documentation which supports it. The course also sets out the roles and responsibilities of different individuals involved in the process, and the ethical and legal considerations that influence the practice of informed consent. Delegates will be able to acknowledge their personal and professional accountability when participating in the consent process, and will know where to go for further advice/support and how to develop and maintain competence in the valid informed consent process.

This programme is for people who have no, or very little, previous experience or training in running meetings or delivering training events. It is available to anyone, irrespective of banding or length of service, who would like to offer training or facilitate meetings.

The aim of the event is to introduce the skills of training and facilitation so delegates structure and manage meetings and training sessions to achieve an agreed outcome.

  • The objectives of the event are that by the end of the training delegates will be able to:
  • Describe the role of the facilitator/trainer and the skills required to plan and run an effective event;
  • Discuss how adults learn and the implications of this in the planning and delivery of effective events;
  • Outline the structure of a training event;
  • Demonstrate questioning and feedback skills which will enhance a learners experience;
  • Identify actions they can take at work which will further develop their confidence in the areas explored during this session.

 Programme Outline

What is the role of trainer/facilitator?

What skills are required?

How do people learn?

  •             How can we use this knowledge to ensure effective events?
  •             The structure of a training session
  •             Questioning skills
  •             Feedback skills
  •             Practice in small groups

Action planning and programme review

This programme is intended for those people who have recently attended the introductory programme to training and facilitation skills. The programme is available to anyone, irrespective of banding or length of service, who would like to offer training or to facilitate meetings.

Delegates will be asked to deliver a brief (15 minutes) training session during the day; part of their training will be in the preparation and delivery of their session and in the receipt of feedback from their peers also on the programme. They will, therefore, be asked to bring with them an outline of an appropriate session, planned to the extent of the learning obtained from the introductory session they attended.

The aim of the event is to consolidate the learning of the introductory programme and to enhance presentation skills and techniques designed to encourage participation.

The objectives of the event are that by the end of the training, delegates will be able to:

  • Prepare and deliver a brief group training session using the recommended structure to achieve a specific learning objective;

  • Demonstrate effective facilitation skills that will ensure participation throughout the training session;

  • Utilise observation and feedback skills to support group members in the development of their training and facilitation skills;

  • Identify actions they can take at work which will further develop their confidence in the areas explored during this session.