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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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.

8. What does it look like?

9. What does it look like?

10. 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.

11. Support materials for Good Clinical Practice available from: