Good Clinical Practice Training (GCP) Refresher

Good Clinical Practice and Regulatory Requirements for Medical Research -

An Introduction to GCP

Course Overview

Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted. Compliance with GCP provides public assurance that the rights, safety and wellbeing of research participants are protected and that research data is reliable. All staff who work in clinical trials at CUH, sponsored or conducted within CUH, are required to undertake GCP training and must hold a valid full GCP training certificate.

From 28th April 2026, training in and compliance with ICH E6 R3 will be a legal requirement. In February and March there is an opportunity to book a 2 hour face to face GCP refresher course focussing on the new ICH E6 R3 updates and CT Regulations. Please note this is not suitable for staff without existing current GCP training. Booking is open to all, however, in the event of oversubscription, priority will be given to staff working on CTIMPs. Training will be registered with TransCelerate and will come with CPD Points. Certificates will be issued after completion of an online quiz post training.

Target Participants

• Site based researchers – all levels

Structure

The course is made up of following updated modules:

- Principles of Good Clinical Practice

- Investigator Responsibilities

- Management of research submissions, approval and reporting

- Protocol compliance

- Care of participants

- Informed consent

- Safety reporting

- Investigational product management

- Document management

- Data governance

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.

Info: Shirley Hallam has worked in clinical research and development within the pharmaceutical industry since 1990 for pharmaceutical companies, Contract Research Organisations and non-commercial sponsors. She has conducted GCP audits of phase I-IV clinical trials in most European countries and the USA. She has experience of investigational site, trial master file, database and clinical report audits, and preparation for regulatory inspection with the MHRA, EMA and the FDA. Shirley advises on clinical quality management systems, including writing and managing Standard Operating Procedures. She is also an experienced trainer, and is Course Principal for the Research Quality Association Advanced Audit Skills courses. Shirley holds the Institute of Clinical Research post-graduate diploma in Clinical Research, and the RQA Certificate of Quality Management. She is a member of the RQA Global Engagement Team, providing outreach to external organisations including Trust-based and academic research.

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