GCP Training for Laboratory Staff

Good Clinical Practice

for Clinical Laboratories

Overview

A two-hour course providing an overview of Good Clinical Practice (GCP) and its application to clinical research laboratories. The training includes presentations and some group work.

The course is registered with Transcelerate Biopharma, which gives assurance to external sponsors of research that GCP training has covered all essential elements. After the course there will be a 10-question multiple choice test to confirm understanding of core GCP elements, prior to the issue of an attendance certificate.

Target Participants

Academic researchers and laboratory staff involved in processing and handling clinical research samples.

Agenda

1. Principles of Good Clinical Practice

2. Review of GCP principles applied to handling, analysis and management of clinical laboratory samples

3. Recent Developments

4. Q and A

A pre-course handout covering core GCP principles will be provided, based primarily on section 4 of the ICH GCP guideline version R2, setting out responsibilities and actions for health care staff at investigational sites. Delegates are advised to spend 20-30 minutes reviewing the handout material before the course.

Learning Outcomes

Following the course participants should be able to:

• Demonstrate awareness of the principles and key purposes of Good Clinical Practice

• Understand how the principles of GCP apply to the management of clinical laboratory samples.

Assessment

Multiple-choice test

Training certificate

Trainer

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

Shirley Hallam has worked in clinical research and development for over 20 years. She has conducted GCP audits of phase I-IV clinical trials in most European countries and the USA. She advises on clinical quality management systems, and is an experienced GCP trainer.

Shirley is a trained ISO lead auditor and a member of the Research Quality Association. She 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.

For further information see website: www.gcp-quality.com.

Host or Publisher R&D Department