Course Leads

Our courses are developed and led by experts at the cutting edge of Clinical Trials theory and practice

James Gibson BSc          Monitoring and Audit

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I head the Quality Assurance team for Edinburgh CRF including two MHRA Phase I accredited adult units, a paediatric unit and a clinical imaging centre. While working in the University of Edinburgh on a programme of early phase clinical trials of a gene therapy product for the treatment of Cystic Fibrosis I developed an interest in the quality management of clinical trials. I now lead the CRF's quality assurance policy and strategy, through the development and implementation of quality systems that ensure the safety of trial participants, the integrity of research data, and CRF compliance with the requirements of the MHRA Phase I Accreditation Scheme and other applicable regulations. I am an expert member of the Edinburgh Phase I Study Review Committee providing specialist guidance on quality systems, the accreditation scheme requirements, and risk management for Phase I / First in Human studies. I am a member of the UKCRF Network Quality Assurance Workstream and am an accredited NRS GCP Trainer.

Andrew Duckworth BSc(Hons), MBChB, MSc, FRCSEd(Tr&Orth), PhD          Good Clinical Practice, Ethics and Regulatory Issues

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I am currently finishing my training as a Specialty Registrar in Trauma and Orthopaedic Surgery at the Royal Infirmary of Edinburgh.  I have just been appointed to the post of Consultant Orthopaedic Trauma Surgeon within the department and will take up post in January 2018.  My clinical interests are in trauma and upper limb surgery, with a focus on injuries around the elbow and wrist.  I was awarded my PhD from the University of Edinburgh in 2016 for my dissertation entitled 'Proximal Forearm Fractures: epidemiology, functional results and predictors of outcome’.  This included two prospective randomised controlled trials on the management of olecranon fractures.  My current research interests include clinical trials in orthopaedic trauma, patient reported outcome measures and health economic analysis.  I have been involved with the MSc Clinical Trials since the start of the course in 2013.

Michelle Evans BSc, MSc, FHEA          Year 3 Dissertation

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I am the programme lead and have overall responsibility for leading and managing the delivery of the MSc in Clinical Trials. I oversee the creation, delivery, on-going assessment and academic governance of the programme. I have over 15 years experience working in a clinical research and education environment.  I hold an MSc in Public Health and a Postgraduate Certificate in Medical Education. My particular interests include patient and public involvement in research and the development and design of clinical research training.

Stuart Ralston MBChB, MD, MRCP, FRCP, FM, FRSE          Introduction to Clinical Trials, Study Design

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I am director of Edinburgh University's online distance learning MSc in clinical trials and was director of Edinburgh Clinical Trials Unit between 2009 and 2016.  I hold an honorary consultant rheumatologist position with NHS Lothian where I am clinical lead for the osteoporosis service and clinical director of the rheumatology service.  I have researched widely on the molecular and genetic basis of osteoporosis and other bone and joint diseases and have a special interest in the pathogenesis and management of Paget’s disease of bone.  I am  joint editor-in-chief of Calcified Tissue International and editor of Davidson's Principles and Practice of Medicine. I currently chair the Commission for Human Medicines for the UK Medicines and Healthcare products Regulatory Agency (MHRA).
 

Craig Ritchie          Principles of Clinical Trial Management

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I am Professor of the Psychiatry of Ageing at the University of Edinburgh

I am a leading authority on Clinical Trials in Dementia and have been senior investigator on over 30 drug trials of both disease modifying and symptomatic agents for that condition. .

I have published extensively on the topics of dementia and delirium including clinical trials and meta-analyses. I sit on several advisory boards for major pharmaceutical and biotechnology companies as well as The Wellcome Trust and the Public Health Steering Group for the Alzheimer’s Society. I am one of the leading editors in the Cochrane Collaboration’s Dementia Group with a particular specialism in Diagnostic Test Accuracy reviews and am Assistant Editor for the journal International Psychogeriatrics.

I lead the PREVENT project; a major initiative nationally which will identify mid-life risks for later life dementia and characterize early changes of neurodegenerative disease through imaging, genetic, cognitive and biomarker analyses.

I also lead the EPAD (European Prevention of Alzheimer’s Dementia) Consortium which is an IMI funded, 5-year grant application to establish a Pan-European network of Trial Delivery Centers with supporting infrastructure to undertake a perpetual, Proof of Concept multi-arm trial secondary trial for secondary prevention of Alzheimer’s dementia. This work will be led from Edinburgh.

Paula Smith BSc, PhD, FHEA          Pharmacovigilance

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I am a Senior Lecturer/Academic e Facilitator on the MSc in Surgical Sciences, an online programme delivered in partnership between the University of Edinburgh and the Royal College of Surgeons of Edinburgh. I previously held lectureships in Neuropharmacology and Biomedical Science/Toxicology, and conducted postdoctoral research as a recipient of a Wellcome Trust Fellowship at the University of Toronto, Canada. I have taught in industry (CROs) and academia, both in the UK and overseas, and currently run the MScCT Year 2 Pharmacovigilance course. I have a BSc and a PhD in Pharmacology, both from the University of Edinburgh.

Allison Worth BSc (Hons), PhD, RGN, RMN, HV          Patient and Public Involvement

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I am Patient and Public Involvement Advisor for the Edinburgh Clinical Research Facility at the University of Edinburgh. My role is to support research staff and members of the public to make patient and public involvement effective and enjoyable for all. I have a background in nursing and am an experienced healthcare researcher and educator. My research focus has been qualitative research trying to understand and improve the experiences of patients with long term and life-limiting conditions. 

 

Monitoring and Audit James Gibson (BSc)

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I head the Quality Assurance team for Edinburgh CRF including two MHRA Phase I accredited adult units, a paediatric unit and a clinical imaging centre. While working in the University of Edinburgh on a programme of early phase clinical trials of a gene therapy product for the treatment of Cystic Fibrosis I developed an interest in the quality management of clinical trials. I now lead the CRF's quality assurance policy and strategy, through the development and implementation of quality systems that ensure the safety of trial participants, the integrity of research data, and CRF compliance with the requirements of the MHRA Phase I Accreditation Scheme and other applicable regulations. I am an expert member of the Edinburgh Phase I Study Review Committee providing specialist guidance on quality systems, the accreditation scheme requirements, and risk management for Phase I / First in Human studies. I am a member of the UKCRF Network Quality Assurance Workstream and am an accredited NRS GCP Trainer.

James Gibson BSc          Monitoring and Audit

I head the Quality Assurance team for Edinburgh CRF including two MHRA Phase I accredited adult units, a paediatric unit and a clinical imaging centre. While working in the University of Edinburgh on a programme of early phase clinical trials of a gene therapy product for the treatment of Cystic Fibrosis I developed an interest in the quality management of clinical trials. I now lead the CRF's quality assurance policy and strategy, through the development and implementation of quality systems that ensure the safety of trial participants, the integrity of research data, and CRF compliance with the requirements of the MHRA Phase I Accreditation Scheme and other applicable regulations. I am an expert member of the Edinburgh Phase I Study Review Committee providing specialist guidance on quality systems, the accreditation scheme requirements, and risk management for Phase I / First in Human studies. I am a member of the UKCRF Network Quality Assurance Workstream and am an accredited NRS GCP Trainer.

Photo of James Gibson

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