GCP Train the Trainer
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.
Addressing ongoing GCP
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.
However, increasingly FDA, MHRA 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.
Current GCP programs available in Australia (and globally) offer individual staff the chance to undertake GCP training but do not equip institutions with ongoing programs that support continuous GCP compliance or give staff the skills and knowledge to create an environment of GCP compliance and education.
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 in Australia (and 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.
Please click here to see a list of all organisations currently using the Sophie Mepham GCP Train the Trainer model
Design and delivery of the GCP programs and materials
Phase I of the program includes the following materials designed and delivered to site:
Introduction to Good Clinical Practice. This program is TransCelerate accredited and is suited to all staff involved in the clinical research environment, particularly staff new to research. It includes 5 modules designed specifically for the Australian regulatory environment. Please contact Sophie Mepham GCP if you are outside Australia - the GCP Train the Trainer program is available for implementation in other countries.
Refresher GCP. A program designed to be delivered to research staff once they have received the Introduction to Good Clinical Practice training or if staff need training in a shorter training program. This program is TransCelerate accredited.
Short session GCP for:
Nursing and clinical staff
In addition to the GCP slides, the following will also be provided:
Access to the members area of the Sophie Mepham GCP website where all training materials will be made available.
The GCP workshop booklets (Introduction and Refresher)
A GCP Facilitator handbook
All training material and activity documents
The Introduction and Refresher GCP will both be TransCelerate accredited by Sophie Mepham and listed on the TransCelerate website under the Organisations name as a recognized training program as part of delivery of phase 1.
All GCP materials are updated as new regulatory updates and changes are released. The next significant update to materials is expected towards the end of 2021 when ICH GCP E6 R(3) is released.
Delivery of GCP program and training the trainers
Training the trainers can usually be managed over 1 day or can be extended over 2 days as needed. Staff will receive all the training needed to become GCP trainers themselves. Please contact Sophie Mepham GCP for further details
Ongoing mentorship and support for trainers and regulatory compliance (optional)
The journey to becoming a highly skilled GCP trainer can take many months and more so if the trainer does not have a strong background in clinical research. New TransCelerate initiatives can also impact on GCP training information. If sites request this service, Phase 3 provides the organisation and the trainers with ongoing leadership, mentorship, guidance and support for the new trainees, who will have the ability to ask any number of questions, discuss new regulations or ask questions posed by attendees during the training sessions.
This phase ensures that the quality of the GCP training by new trainees always remains high.