Introduction to Good Clinical Practice Training (GCP)

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.

Host or Publisher R&D Department