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Good Clinical Practice training programs

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.

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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 TGA, 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 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.

TransCelerate

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 here to see a list of all organisations currently using the Sophie Mepham GCP Train the Trainer model

Phase 1:
Design and delivery of the GCP programs and materials

Phase I of the program includes the following materials designed and delivered to site:
 

  1. Introduction to Good Clinical Practice. This program is CPD and TransCelerate accredited and is suited to all staff involved in the clinical research environment, particularly staff new to research. 

  2. 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 CPD and TransCelerate accredited.

  3. Short session GCP for:

    1. Nursing and clinical staff

    2. Pharmacy

    3. Radiology

    4. Pathology GCP
       

In addition to the GCP slides, the following will also be provided:

  1. Provision of all training materials and activity documents

  2. The GCP workshop handbook

  3. The GCP Facilitator handbook

  4. Sites can also have their own dedicated online GCP programs to complement the face to face training modules

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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 2024/early 2025 when ICH GCP E6 R(3) is released.

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Introduction to GCP is 6 hours long and applicable attendees can gain 6 CPD points for attending. Refresher GCP is 2 hours long and applicable staff can gain 2 CPD points for attending.

Phase 2:
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

Phase 3:
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.

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Sophie Mepham provides Good Clinical Practice education, training and resources, especially designed for clinical trials staff at hospitals, research institutes and Universities.

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Training is CPD certified and Transcelerate accredited.

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Training is delivered both online - to anywhere in the world - and face-to-face.

Sophie Mepham GCP Services:

  • GCP training face to face or via videoconference

  • GCP train the trainer

  • GCP online, self-paced modules

  • GCP regulatory compliance post audit/inspection

Sophie Mepham GCP training is ideally suited to site-level clinical trial staff working in drug trials, including Principal Investigators, Sub-Investigators, Research Nurses, Research Coordinators, Clinical Research Assistants, and anyone who is wanting to move into site-level clinical trials. ​

©2024 by Sophie Mepham GCP   |   ABN: 4959 2354 584   |   PRIVACY POLICY 

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