“An online programme of courses to ensure clinical research complies with the ICH Guidelines for Good Clinical Practice.”

Introduction Developed in collaboration with: Good Clinical Practice covers the key issues of good clinical practice to ensure that clinical trials comply with the ICH Guidelines for Good Clinical Practice, in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments. The courses are designed for researchers working on medicines for human use, including principal investigators, trial managers, research nurses and those on research ethics committees. The programme has been approved by the Royal College of Physicians for a total of seven distance-learning CPD credits. Developed in collaboration with: Addenbrookes Hospital NHS Trust Brighton and Sussex University Hospitals NHS Trust Chelsea and 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 University of Oxford and Oxford University Hospitals NHS Trust Royal Brompton and Harefield NHS Trust Sheffield Teaching Hospitals NHS Trust and Sheffield University St Mary’s NHS Trust

Contributors First Edition Authored by: Dr Phaik Yeong Cheah - Head of the Clinical Trials Support Group, Mahidol Oxford Tropical Medicine Research Unit, Bangkok Paula Nicolson - Former Research Facilitator, Clinical Research Governance Office, Imperial College London Gary Roper - Head of Regulatory Compliance, Clinical Research Governance Office, Imperial College London Patricia Henley - Quality and Governance Manager, London School of Hygiene and Tropical Medicine Heather House - Research & Development Lead, Oxford University Hospitals Trust; Head of the Clinical Trials and Research Governance Team, University of Oxford   Second Edition Updates Authored by: Carol Cornelius – Senior Research Support Associate, Clinical Trials and Research Governance, Research Services, University of Oxford Reviewers: Sarah Rickard - Network Manager, Greater Manchester, Lancashire and South Cumbria Medicines for Children Research Network Sue Bulley - Research & Development Manager, Yeovil District Hospital Fiona Bull- Contract Clinical Project Manager, Prosensa Therapeutics B.V. Professor Jane Armitage - Professor of Clinical Trials and Epidemiology, Nuffield Department of Clinical Medicine, University of Oxford

About the course Structure: Who is it for? 10 hours Comprised of five courses: Protocol and associated documents Applications, agreements and approvals Trial master files Conducting the trial Safety reporting Who is it for? Researchers working on medicines for human use, including principal investigators, trial managers, research nurses and those on research ethics committees. Second Edition Published: August 2014

Overview and content Course and Times Syllabus Authors/Reviewers Protocol and associated documents 2 hours Module 1: Introduction to GCP compliance Module 2: Protocol: objectives, design and methodology, eligibility and withdrawal criteria, accountability and safety, data and records, ethics and review Module 3: Associated documents: Participant Information Sheet, Consent Form, and Case Report Form Author: Dr Phaik Yeong Cheah Reviewer: Sarah Rickard Applications, agreements and approvals Module 1: Agreements and responsibilities Module 2: Applications including ethics approval Module 3: Approvals and amendments  Author: Paula Nicolson & Gary Roper Reviewer: Sue Bulley Trial master files Module 1: Introduction to document keeping and legal regulations Module 2: Contents of the Trial Master File Module 3: Management, maintenance and archiving Author: Patricia Henley & Gary Roper Reviewer: Professor Sue Bulley

Course and Times Syllabus Authors/Reviewers Conducting the trial 2 hours Module 1: Pre-trial activities: Standard Operating Procedures, authority, confidentiality and data protection Module 2: Recruitment: identifying participants, the consent process, amendments and communicating enrolment Module 3: During the trial: visits, monitoring, records and review Author: Heather House Reviewer: Fiona Bull Safety reporting Module 1: Definitions, timelines and responsibilities Module 2: Reporting adverse events and assessing causality Module 3: Serious adverse events, expectedness, expedited reporting and follow-up Module 4: Overviews and reports Reviewer: Professor Jane Armitage

Course features Interactive activities and quizzes to engage participants and test their understanding of the material covered. Video interviews with experts sharing their experiences and advice. Video dramas and activities featuring a cast of characters to illustrate and reinforce key learning points. Practical scenarios allowing participants to apply what they have learned to realistic situations. Resource banks directing participants to other useful materials for further study.

What does it look like?

What does it look like?

Learning outcomes By completing this programme, researchers will understand: How to write, review and maintain essential documents for a clinical trial. The agreements, applications and approvals necessary to ensure ICH GCP compliance Issues relating to participant recruitment, informed consent, accountability and review during a trial. Safety issues and procedures for assessing and reporting adverse events.

Support materials for Good Clinical Practice available from: https://www.epigeum.com/customer-support/implementation-toolkit/course-tools/good-clinical-practice/