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Sophie Mepham GCP - Good Clinical Practice training 

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GCP In-Person Training

GCP training in person: Sophie Mepham GCP offers comprehensive CPD certified and TransCelerate accredited Good Clinical Practice training across the research, healthcare and academic sector. GCP training can be delivered online via videoconference (Covid safe) or face to face where safe to do so. Introduction to GCP and Refresher GCP options are available. Training is ideally suited to staff working at site level with patients, such as Principal Investigators, Sub Investigators, Research Nurses, Research Coordinators, Pharmacists, Data Managers and Clinical Research Assistants.

Sophie Mepham GCP is a provider of CPD certified and TransCelerate accredited Good Clinical Practice (GCP) training and GCP compliance for clinical trials staff in hospitals, research institutes, and universities around the world. As a Good Clinical Practice certified trainer based in Australia (Q-IAOCR), Sophie Mepham GCP offers practical and effective ways to implement and manage GCP and GCP compliance at the site level and to support staff involved in managing externally sponsored trials and site-sponsored Investigator Initiated Trials. GCP training can be delivered inperson for Australian and New Zealand sites or face to face via videoconference for clients outside of Australia.

Sophie Mepham GCP services include online and face-to-face GCP training, GCP Train the Trainer and support with managing GCP compliance issues post audit or inspection by Sponsor or competent authority. 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.

On completion of the GCP training, and in partnership with the International Accrediting Organization for Clinical Research (IAOCR), attendees can progress to an independent assessment of their GCP knowledge and professional competence via the IAOCR GCP accreditation assessment. Participants successfully achieving this accreditation can advance their career and increase employabiltiy by providing evidence to employers and the industry that they can demonstrate all the relevant GCP core competencies expected of a competent clinical research professional

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:

  • GCP - the background and why we need it

  • Study set up, roles and responsibilities and essential documents

  • Informed Consent

  • Case Report Forms, source documents and source data

  • Safety reporting

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GCP Train The Trainer

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. Programs include Introduction to GCP, Refresher GCP and short sessions for nursing, pathology, pharmacy and radiology staff. Staff attending the Introduction to GCP or Refresher GCP training can claim CPD points for their attendance where applicable. 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 oportunity 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.

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Contact

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