TRANSFORMING HIGHER EDUCATION THROUGH EXCEPTIONAL ONLINE LEARNING

Authors

1/5

Carol Cornelius: Author

Carol has worked in the Clinical Trials and Research Governance team of at the University of Oxford since 2007, first as a Research Support Associate, and now as Senior Research Support Associate. Her responsibilities include managing a team, providing specialist advice and review of applications for research sponsorship; advising on protocol design; Clinical Trial Authorisations; pharmacovigilance and other regulatory issues; maintaining oversight of the quality and compliance of the University's clinical research; monitoring and auditing clinical trials on behalf of the University; as well as designing, developing and delivering Good Clinical Practice training for researchers.

2/5

Heather House: Author

Heather House began her experience in clinical research by setting up and conducting an early Phase II trial in Oxford. Expanding the trial activities, she recruited and managed a team of doctors and research nurses which went on to conduct several further Phase I to III trials.

She spent three years as a programme manager in the pharmaceutical industry, developing early phase trials, and had the specific role of providing support and advice to investigators wanting to conduct their own non-commercial trials. With the introduction of the clinical trials regulations, this support became increasingly necessary and her interest in this field increased.

Heather is currently Head of Clinical Trials and Research Governance at the University of Oxford and leads the research and development team at Oxford Radcliffe Hospitals NHS Trust.

3/5

The following authors contributed to the end of course question bank for the Good Clinical Practice programme:

  • Shirley Hallam, Clinical Research Consultant and GCP Auditor, Addenbrookes (Cambridge)
  • Louise Stockley, Research Governance Manager, Addenbrookes (Cambridge)
  • Nabila Youssouf, Clinical Trials Manager, Imperial College London
  • Carol Cornelius, Senior Research Support Associate, Oxford
  • Heather House, Head of CTRG Team, Oxford.

4/5

Heather House: Author

Heather was also the author of the first edition of this course.

5/5

Jane Armitage: Reviewer

Jane Armitage is Professor of Clinical Trials and Epidemiology and Honorary Consultant in Public Health Medicine in the Nuffield Department of Population Health at the University of Oxford. She joined the Clinical Trial Service Unit (CTSU) in 1990 from a background in clinical medicine, with particular experience in respiratory medicine, geriatrics and diabetes. She co-ordinates a series of large-scale clinical trials including the MRC/BHF Heart Protection Study, SEARCH and HPS2-THRIVE, which are trials of lipid modification in people with or at risk of vascular disease, as well as the ASCEND trial of aspirin and fish oils in diabetes. Her main research interests are in lipids and the epidemiology of cardiovascular and other chronic disease.

Learning outcomes

The safety of participants in clinical research is of paramount importance. Understanding the requirements of the regulations and GCP around safety reporting is essential if you are involved in clinical trials. Understanding the consequences of inadequate reporting underlies this. This course covers all the different aspects of safety reporting that you need to know from protocol development to final reporting.

By the end of this course, you should:

  • Appreciate the importance of safety reporting and where it fits within the conduct of a trial
  • Understand the definitions of the different classifications of Adverse Events and the associated reporting requirements
  • Understand how to assess whether an Adverse Event is serious, expected and related to the study drug
  • Understand the process of expedited reporting
  • Learn how to compile an annual safety report.

Course structure

The diagram on the right explains the chronology of the course. Click on each of the sections to view a more detailed breakdown of this course.

Orientation

Activities clarifying the objectives of this course and helping you gain a feel for how the course will develop.

Course files

The course content. The target knowledge and concepts are introduced during this stage.

Application

A chance to apply the course content to a practical example.

Closing

Summarises what you have learned and provides reference materials for further study.

Course quiz

Supporting institutions

The Good Clinical Practice programme has been developed in conjunction with the following institutions:

  • Addenbrookes Hospital NHS Trust
  • Brighton & Sussex University Hospitals NHS Trust
  • Chelsea & Westminster Healthcare NHS Trust
  • Glasgow University and Greater Glasgow Health Board
  • Hammersmith Hospitals NHS Trust
  • Imperial College London
  • Manchester University and Central Manchester and Manchester Children's Hospitals NHS Trust
  • North West London Hospitals NHS Trust
  • Oxford University and Oxford Radcliffe Hospitals NHS Trust
  • Royal Brompton & Harefield NHS Trust
  • St Mary's NHS Trust
  • Sheffield Teaching Hospitals NHS Trust and Sheffield University

Authors

Carol Cornelius: Author

Carol has worked in the Clinical Trials and Research Governance team of at the University of Oxford since 2007, first as a Research Support Associate, and now as Senior Research Support Associate. Her responsibilities include managing a team, providing specialist advice and review of applications for research sponsorship; advising on protocol design; Clinical Trial Authorisations; pharmacovigilance and other regulatory issues; maintaining oversight of the quality and compliance of the University's clinical research; monitoring and auditing clinical trials on behalf of the University; as well as designing, developing and delivering Good Clinical Practice training for researchers.


Heather House: Author

Heather House began her experience in clinical research by setting up and conducting an early Phase II trial in Oxford. Expanding the trial activities, she recruited and managed a team of doctors and research nurses which went on to conduct several further Phase I to III trials.

She spent three years as a programme manager in the pharmaceutical industry, developing early phase trials, and had the specific role of providing support and advice to investigators wanting to conduct their own non-commercial trials. With the introduction of the clinical trials regulations, this support became increasingly necessary and her interest in this field increased.

Heather is currently Head of Clinical Trials and Research Governance at the University of Oxford and leads the research and development team at Oxford Radcliffe Hospitals NHS Trust.


The following authors contributed to the end of course question bank for the Good Clinical Practice programme:

  • Shirley Hallam, Clinical Research Consultant and GCP Auditor, Addenbrookes (Cambridge)
  • Louise Stockley, Research Governance Manager, Addenbrookes (Cambridge)
  • Nabila Youssouf, Clinical Trials Manager, Imperial College London
  • Carol Cornelius, Senior Research Support Associate, Oxford
  • Heather House, Head of CTRG Team, Oxford.

Heather House: Author

Heather was also the author of the first edition of this course.


Jane Armitage: Reviewer

Jane Armitage is a Reader in Clinical Epidemiology and Honorary Consultant in Public Health Medicine at the University of Oxford. She joined the Clinical Trial Service Unit (CTSU) in 1990 from a background in clinical medicine, with particular experience in respiratory medicine, geriatrics and diabetes. She co-ordinates a series of large-scale clinical trials including the MRC/BHF Heart Protection Study, SEARCH and HPS2-THRIVE, which are trials of lipid modification in people with or at risk of vascular disease, as well as the ASCEND trial of aspirin and fish oils in diabetes. Her main research interests are in lipids and cardiovascular epidemiology.


Learning outcomes

The safety of participants in clinical research is of paramount importance. Understanding the requirements of the regulations and GCP around safety reporting is essential if you are involved in clinical trials. Understanding the consequences of inadequate reporting underlies this. This course covers all the different aspects of safety reporting that you need to know from protocol development to final reporting.

By the end of this course, you should:

  • Appreciate the importance of safety reporting and where it fits within the conduct of a trial
  • Understand the definitions of the different classifications of Adverse Events and the associated reporting requirements
  • Understand how to assess whether an Adverse Event is serious, expected and related to the study drug
  • Understand the process of expedited reporting
  • Learn how to compile an annual safety report.

Course structure

The bullet points below explain the chronology of the course and give a breakdown of each of the sections you will encounter.


Orientation

The Orientation section introduces you to the content and aims of the course. There is an opportunity to assess your current knowledge, to help you evaluate your learning at the end of the course.

  • Introduction

Course files

The course files contain the core course content. The content is divided into units and screens.

  • Unit 1: Definitions
  • Unit 2: Reporting
  • Unit 3: Serious Adverse Events
  • Unit 4: Overviews and reports

Application

The Application section gives you the chance to apply the course content to a practical example.

  • Practical scenario 1
  • Practical scenario 2

Closing

The Closing section summarises what you have learned and provides reference materials for further study.

  • Course summary
  • Resource bank

Course quiz

The Course quiz section allows you to assess and consolidate what you have learned in the course.

  • Course quiz

Supporting institutions

The Good Clinical Practice programme has been developed in conjunction with the following institutions:

  • Addenbrookes Hospital NHS Trust
  • Brighton & Sussex University Hospitals NHS Trust
  • Chelsea & Westminster Healthcare NHS Trust
  • Glasgow University and Greater Glasgow Health Board
  • Hammersmith Hospitals NHS Trust
  • Imperial College London
  • Manchester University and Central Manchester
    and Manchester Children's Hospitals NHS Trust
  • North West London Hospitals NHS Trust
  • Oxford University and Oxford Radcliffe Hospitals NHS Trust
  • Royal Brompton & Harefield NHS Trust
  • St Mary's NHS Trust
  • Sheffield Teaching Hospitals NHS Trust and Sheffield University