Thursday, 17 October

Introduction to Good Clinical Practice Training (GCP)

It is Trust policy for all staff involved in clinical trials of investigational medicinal products (CTIMPs) to complete GCP Training.

By Research and Development Department

Date and time

Thu, 17 Oct 2024 09:00 - 13:00 GMT+1

Location

School of Clinical Medicine

Hills Road Room TBA Cambridge CB2 0SP United Kingdom

About this event

4 hours

Good Clinical Practice and Regulatory Requirements for Medical Research -

An Introduction to GCP

Course Overview

A half day course providing an understanding of Good Clinical Practice (GCP) and its application to clinical research working practices.

The course is registered with Transcelerate Biopharma Inc and includes principal elements from ICH Good Clinical Practice guideline E6 R2. It also considers the HRA UK Policy Framework for Health and Social Care Research, and is applicable to all medical research conducted in a health setting.

Target Participants

• Site based researchers – all levels

Structure

The course is made up of 5 modules:

1. Principles of Good Clinical Practice

2. Managing a Research Project/ Clinical Trial

3. Informed Consent

4. Safety and Adverse Event Reporting

5. Good Documentation Practice, Data Integrity and End of Trial Activities

Learning Outcomes

Following the course participants should be able to:

• Demonstrate awareness of the key purposes of Good Clinical Practice; i.e.

• protection of the rights, integrity and confidentiality of research participants

• production of data which are credible and accurate.

• Demonstrate awareness of the principles of Good Clinical Practice

• Be aware of the history of clinical research and understand the necessity of ongoing vigilance to ensure GCP is followed

• Demonstrate an understanding of the current regulatory framework for clinical research

• Understand the process of receiving informed consent and the roles and responsibilities of those involved in this process

• Demonstrate an awareness of the correct safety reporting requirements that ensure patient safety

• Understand the importance of maintaining documents, and processes for data compilation and correction

• Know where to go for further advice and support.

Assessment

Multiple-choice test – pass mark = 80%

Training certificate

Trainer

This training session is provided by Shirley Hallam of Hallam Pharma Consulting Ltd.

Frequently asked questions

Who is the Introduction to GCP Training for?

All clinical staff at CUH involved in human research

Can my department pay for my GCP Training?

Please consult with your line manager if your department is able to cover the cost of the training. Should they agree, please fill out the Transfer of Expenditure form and return it to Carla Flores from the R&D Department

How long does the certification last?

Full GCP Training is needed to receive your first certification. After 2 years of your first GCP Certification, research staff is required to complete a GCP Refresher and Update Training. GCP Certification is then to be renewed every 2 years through the GCP Refresher and Update Trainings.

Who do I send my GCP Certificate to? and why?

The R&D Department requires GCP Certificates of all researchers and clinical staff involved in human research. Please send your most recent GCP Certificate to Carla Flores at the R&D Department: carla.flores@nhs.net

Organised by

Research and Development Department

The R&D Department at Cambridge University Hospitals NHS Foundation Trust oversees all the biomedical research taking place on the Cambridge Biomedical Campus that involves hospital patients, their data or tissues, or uses Trust facilities and staff.

We're based at the heart of the Cambridge Biomedical Campus, one of the largest biomedical campuses in Europe, and we help to support world-leading experimental and translational medicine, including:

• testing new drugs / therapies and ways to deliver them

• testing new devices to improve diagnosis / recovery

• asking patients to complete qualitative questionnaires

• asking patients to take part in a series of tests, e.g. measuring their heart rate and recording the results

We work closely with our partners including the NIHR Cambridge Biomedical Research Centre and the University of Cambridge, and are happy to hear from potential researchers who would like to collaborate with us and use our facilities, whether you are from another NHS Trust, a university or pharmaceutical company.

We also provide advice and training for Trust / Cambridge University health research staff, guiding you through the research application process to ensure that what you do is safe, ethical and complies with all the necessary legislation governing research on people.

Take a look at our courses currently available, these are updated as and when new content is added.

______________________________________________________________________________________________________

Carla Flores

R&D A&PA

GCP at CUH Coordinator

Introduction to Clinical Research at CUH Coordinator

carla.flores@nhs.net

Lauren Basham

R&D Administration Manager

lauren.basham@nhs.net