Good Clinical Practice: Train The Trainer
A program for the design and delivery of a TransCelerate endorsed, organisation wide Train the Trainer GCP program.
Working in partnership, Sophie Mepham GCP™ and PRAXIS Australia provide a unique model of TransCelerate endorsed Good Clinical Practice (GCP) training tailored for all those involved in clinical research.
Background to the Train the Trainer GCP program
Good Clinical Practice (GCP) is the international standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials that involve humans. GCP also serves to protect the rights, welfare, safety and confidentiality of trial subjects. The principles of GCP have their origins in the World Medical Association’s Declaration of Helsinki, first published in 1964.
It is a requirement that all staff involved in clinical research should have evidence of GCP training, and this training must be relevant and appropriate to their role. Industry, regulatory bodies and independent inspectors are also seeking assurance that research staff meet the minimum GCP training standards as defined by groups such as TransCelerate.
In 2011, the National Institute of Health Research (NIHR) in the UK developed a first-of-its-kind national GCP “Train the Trainer” program. This program supports institutions and their research staff to build the skills they need to plan and conduct their own GCP training programs, and is delivered in Australia by Dr Sophie Mepham, under exclusive license from the NIHR. The program is supported by a mentorship program, regular regulatory updates and access to real time support.
Course Design: The Three Elements
|Part A – Design and delivery of the GCP training materials||
Includes all training materials for the following areas:
||Refer to Brochure|
|Part B – GCP Workshop and Train the Trainer||
Day One – 6 hours of Introduction to GCP training provided by Sophie Mepham to the “Trainees” plus up to 50 additional attendees
Day Two (or same day if preferred) – up to 4 hours of one on one facilitation (dependent on number of trainees) and training in how to deliver each of the GCP modules
|Refer to Brochure|
|Part C – (optional) Ongoing mentorship and support for Trainees||The mentoring model provides the organisation and the trainees with ongoing support and mentorship.||Refer to Brochure|
Organisations who undertake this program will be listed on the TransCelerate website by Sophie Mepham as a recognised GCP training program as part of the delivery of Part A.
Good Clinical Practice
You can download this brochure, which describes what we cover in each of our workshops and provides additional information about our in demand GCP Train the Trainer program also.