Private: Good Clinical Practice

Published on: Aug 2014 8 Hours of Core activities

Courses featured in this programme:

  • Protocol and associated documents
    Overview

    Date published: Aug 2014 
    Core activities: 2 hours 
    2 CPD points 
     

    This course aims to teach researchers:

    • The contents of a GCP-compliant protocol
    • How to write and review a study protocol
    • The other documents essential for the conduct of a clinical study.

     

    Syllabus
      • 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
        Head of the Clinical Trials Support Group, Mahidol Oxford Tropical Medicine Research Unit, Bangkok

        Reviewer: Sarah Rickard 
        Network Manager, Greater Manchester, Lancashire and South Cumbria Medicines for Children Research Network

  • Applications, agreements and approvals
    Overview

    Date published: Aug 2014 
    Core activities: 2 hours 
    1 CPD point 
     

    This course will help researchers to understand the regulatory issues involved in setting up a clinical trial, including:

    • The agreements needed for a clinical trial and the division of responsibilities between the Sponsor, Chief Investigator and Principal Investigator
    • The application process for NHS, MHRA and other approvals for a study and common problems that might arise
    • The approvals needed to ensure compliance with ICH GCP and how these relate to amendments.

     

    Syllabus
      • Module 1: Agreements and responsibilities
      • Module 2: Applications including ethics approval
      • Module 3: Approvals and amendments

     

    Author: Paula Nicolson
    Former Research Facilitator, Clinical Research Governance Office, Imperial College London

    Author: Gary Roper
    Head of Regulatory Compliance, Clinical Research Governance Office, Imperial College London

    Reviewer: Patricia Henley 
    Quality and Governance Manager, London School of Hygiene and Tropical Medicine

  • Trial master files
    Overview

    Date published: Aug 2014 
    Core activities: 2 hours 
    1 CPD point 
     

    This course will help researchers to understand:

    • Essential documents and the Trial Master File
    • Why maintaining a Trial Master File is essential to trial management
    • The archiving process
    • How Trial Master Files apply to trial regulation.

     

    Syllabus
      • 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 
        Quality and Governance Manager, London School of Hygiene and Tropical Medicine

        Author: Gary Roper
        Head of Regulatory Compliance, Clinical Research Governance Office, Imperial College London

        Reviewer: Sue Bulley 
        Research & Development Manager, Yeovil District Hospital

  • Conducting the trial
    Overview

    Date published: Aug 2014 
    Core activities: 2 hours 
    1 CPD point 
     

    This course is designed to help researchers understand:

    • What they need to have in place before they start a trial
    • The principles behind recruitment and the informed consent process
    • Drug accountability
    • What aspects of the trial need to be reviewed as the trial progresses.

     

    Syllabus
      • 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 
      Research & Development Lead, Oxford University Hospitals Trust; Head of the Clinical Trials and Research Governance Team, University of Oxford

      Reviewer: Fiona Bull
      Contract Clinical Project Manager, Prosensa Therapeutics B.V.

  • Safety reporting
    Overview

    Date published: Aug 2014 
    Core activities: 2 hours 
    2 CPD points 
     

    Researchers taking this course will learn:

    • The definitions of the different classifications of Adverse Events and the associated reporting requirements
    • How to assess whether an Adverse Event is serious, expected and related to the study drug
    • The process of expedited reporting
    • How to compile an Annual Safety Report.

     

    Syllabus
      • 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

       

      Author: Heather House 
      Research & Development Lead, Oxford University Hospitals Trust; Head of the Clinical Trials and Research Governance Team, University of Oxford

      Reviewer: Professor Jane Armitage 
      Professor of Clinical Trials and Epidemiology, Nuffield Department of Clinical Medicine, University of Oxford