GCP Training Programs
GCP Origins
Good Clinical Practice (GCP) is the international standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that involves humans. It also serves to protect the rights, integrity, 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.
GCP Training Requirements
Today it is expected that all staff involved in clinical research should have GCP training and this training must be relevant and appropriate to the role that each staff member has in the clinical trial. Pharmaceutical and Biotech companies expect to see investigative staff GCP trained as a matter of course and this training should be updated regularly to ensure knowledge remains current.
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However, increasingly Competent Authority regulations and pharmaceutical-driven audits and inspections are looking for ongoing evidence that lead Investigators and research staff are able to demonstrate ongoing GCP awareness and understanding.
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Current GCP programs available in Australia and around the world offer individual staff the chance to undertake GCP training but do not equip institutions with ongoing programs that support continuous GCP compliance or accreditation or give staff the skills and knowledge to create an environment of GCP compliance and education.
GCP Program Overview
The creation of TransCelerate in 2012, an international non-profit organization comprised of the world’s largest CRO, pharmaceutical and biotech companies, has led to a global GCP accreditation initiative. GCP programs that are recognised by TransCelerate guarantee that their training content meets the criteria for the highest standard of GCP compliance and quality and is generally accepted by all pharma and biotech companies.
In 2011, the National Institute of Health Research (NIHR) in the UK developed a first-of-its-kind national GCP “Train the Trainer” program. NHS organisations across the UK were able to have key research members of staff trained to the highest standard, not only in GCP and its associated regulations but also in the art of adult education and facilitation. A GCP program was created that not only equipped institutions to manage their GCP training internally, but also empowered research staff with the practical knowledge they needed to safely and effectively run clinical trials. Sophie Mepham received this training by the NIHR in June 2011.
A unique program is now available globally that allows research institutes, organisations and hospitals to have their own team of highly qualified trainers, equipped with all the materials and support needed to deliver TransCelerate accredited GCP, backed up by a support and mentorship program, regular regulatory updates and access to real time support to ensure the highest level of GCP training at all times.
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Please click below to see a list of all organisations currently using the Sophie Mepham GCP Train the Trainer model
GCP Training Modules
The GCP training comprises five modules and covers all aspects of GCP to ensure that clinical trials are conducted in a way that protects the rights, safety, and well-being of trial participants while generating high-quality data. By completing Sophie Mepham's GCP training, participants will be equipped with the knowledge and skills needed to carry out their roles effectively and to comply with regulatory requirements. ​These modules are:
This GCP training is delivered directly to attendees in real time and can be managed in person or online. Courses available are Introduction to GCP (6 hours) and Refresher GCP (3 hours).
The GCP training is specifically designed for clinical trials staff who currently work or will work at the site level, including Principal Investigators, Sub Investigators, Research Nurses, Research Coordinators, Data Managers, Research Assistants, Pharmacists, and all associated site roles. It is TransCelerate accredited and CPD certified.
GCP Train The Trainer
Sophie Mepham GCP offers a CPD certified and TransCelerate accredited GCP Train the Trainer program. The program allows and supports organisations to deliver their own GCP training in-house. Sophie Mepham will train your own staff to become GCP trainers and provide all the materials needed to deliver the program.
GCP materials are updated for sites whenever regulations or guidelines change. Ideally suited to clinical trials staff working at the site level.
For attendees who become SMGCP trainers, there is the opportunity to assess and accredit their GCP research trainer skills via the Q-IAOCR program. The Internationally Qualified Clinical Research Trainer Accreditation (Q-IAOCR) is relevant to anyone involved in delivering training within a clinical research setting. The Q-IAOCR accreditation process is focused on determining whether a GCP trainer has the skills, knowledge and behaviours to fulfil their role, measured against a set of robust accredited assessment criteria which have been developed from the core competency framework validated by the clinical trials industry.
Online GCP Training
All GCP modules are available to study online at your own pace. Please click the button below to access the online training.