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ICH GCP adapted for the UK in English | Good Clinical Practice Training Course

The course is a current and comprehensive guide to the principles of ICH Good Clinical Practice. Updated Nov 2016.

This training course reviews and demonstrates the principles of GCP including MHRA regulations. Accredited by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom, the course was written by Nick Deaney who has 30 years' experience up to Research Director level in a major pharma group. If you require an understanding of UK GCP this course is for you! Research staff who have monitoring rather than implementation responsibilities will find GCP knowledge extremely valuable. A Qualified Person will benefit from a good general understanding of Good Clinical Practice. Updated with ICH E6 (R2) in Nov 2016.

  • Average study time:
    study time

    6 hrs

  • Personal development points (CPD):
    points

    6 points

  • Price:
    points

    £69.00

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Course Details

Our online courses offer a flexible and cost effective learning opportunity to develop your GCP skills. We offer industry recognised training to add to your professional experience, you can gain professional certification as well as CPD points. Online GCP training means you can study when it suits you!

Benefits for you

  • CPD Points -  This course meets the required standard for basic Good Clinical Practice (GCP) training, allowing learners to work on clinical trials. Learners also receive 6 Continual Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
  • Certification - Receive a personal certificate to show your subject knowledge on course completion.
  • Affordable - You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
  • Flexible - The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
  • Up to Date - You will stay up to date with any legislative changes in GCP as our training courses are constantly monitored, reviewed and updated.
  • Learn from Industry Experts - The course content has been developed to ensure that you comply with ICH-GCP regulations through the application of learning outcomes. The course provides case scenarios, taken from real life examples encountered by author, Nick Deaney; who has 30 years' experience up to Research Director level in a major pharma group.

Course Syllabus

Chapter 1: Introduction

  • 1.1 Background 
  • 1.2 What is GCP? 
  • 1.3 Why should we have ICH-GCP? 
  • 1.4 How was GCP introduced into the UK? 
  • 1.5 The Principles of GCP 
  • 1.6 Some General Points 
  • 1.7 Documentation and Version Control 
  • 1.8 Quality Assurance 
  • 1.9 Other Resources 

Chapter 2: Competent Authorities (CA) and Independent Ethics Committee (IEC)

  • 2.1 About this Chapter 
  • 2.2 Introduction 
  • 2.3 Responsibilities of the CA 
  • 2.4 Responsibility of IEC 
  • 2.5 Subject Informed Consent Forms (ICF) I 
  • 2.6 Subject Informed Consent Forms (ICF) II 
  • 2.7 Composition, Functions, Operations, Procedures and Records 
  • 2.8 IEC interactions with Sponsors and Investigators 

Chapter 3: Investigator Responsibilities 

  • 3.1 About this Chapter 
  • 3.2 Introduction 
  • 3.3 Investigator Responsibilities 
  • 3.4 Investigator's Qualifications and Agreements 
  • 3.5 Adequate Resources 
  • 3.6 Medical Care of Trial Subjects 
  • 3.7 Communication with IRB/IEC 
  • 3.8 Compliance with the Protocol
  • 3.9 Investigational Medicinal Product 
  • 3.10 Randomization Procedures and Un-blinding 
  • 3.11 Informed Consent I 
  • 3.12 Informed Consent II - The Consent Discussion 
  • 3.13 Informed Consent III - Vulnerable Patients 
  • 3.14 Informed Consent IV - Patients who Cannot Read or Write 
  • 3.15 Informed Consent V - Minors and "Incompetent" Patients 
  • 3.16 Informed Consent VI - Incapacitated Subjects 
  • 3.17 Informed Consent VII - Updating Consent 
  • 3.18 Records and Reports I 
  • 3.19 Records and Reports II - Study Site Files 
  • 3.20 Records and Reports III - Updates & Amendments 
  • 3.21 Records and Reports IV - Source Documents 
  • 3.22 Records and Reports V - Financial Information & Contracts 
  • 3.23 Records and Reports VI - The Case Record Form (CRF) 
  • 3.24 Records and Reports VII - Recording Subject Data 
  • 3.25 Premature Termination or Suspension of a Trial 
  • 3.26 Progress & Final Reports by Investigator 
  • 3.27 Archiving 

Chapter 4: Sponsor Responsibilities 

  • 4.1 About this Chapter 
  • 4.2 Introduction 
  • 4.3 Quality Management I 
  • 4.4 Quality Management II 
  • 4.5 Quality Assurance and Quality Control I 
  • 4.6 Quality Assurance and Quality Control II - SOPs 
  • 4.7 Quality Assurance and Quality Control III - Agreements & Contracts 
  • 4.8 Contract Research Organisations 
  • 4.9 Trial Design 
  • 4.10 Trial Management I 
  • 4.11 Trial Management II - Data Management 
  • 4.12 Trial Management III - Electronic Data Systems 
  • 4.13 Trial Management IV - Record Keeping 
  • 4.14 Investigator Selection I 
  • 4.15 Investigator Selection II - Permissions 
  • 4.16 Investigator Selection III - Responsibilities 
  • 4.17 Investigator Selection IV - Compensation
  • 4.18 Financing 
  • 4.19 Notification/Submission to Regulatory Authorities 
  • 4.20 Gaining CA approval in the EU 
  • 4.21 Confirmation of Review by IRB/IEC 
  • 4.22 Manufacturing, Packaging, Labelling and Coding Investigational Products 
  • 4.23 Supplying and Handling Investigational Products 
  • 4.24 Audit and Inspection 
  • 4.25 Noncompliance 
  • 4.26 Premature Termination or Suspension of a Trial 
  • 4.27 Clinical Trial/Study Reports 
  • 4.28 Multicentre Trials 

Chapter 5: Monitor Responsibilities 

  • 5.1 About this Chapter 
  • 5.2 Introduction 
  • 5.3 Monitoring 
  • 5.4 Verifying IMP 
  • 5.5 Compliance 
  • 5.6 Verifying Consent 
  • 5.7 CRF & Source Docs 
  • 5.8 Verifying Subject Data 
  • 5.9 Errors in CRFs 
  • 5.10 Closing Out the Monitoring Visit 
  • 5.11 The Monitoring Report & Plan 
  • 5.12 Quality Management - Centralized Monitoring 
  • 5.13 Fraud and Misconduct 

Chapter 6: Safety & Adverse Event Reporting 

  • 6.1 About this Chapter 
  • 6.2 Introduction 
  • 6.3 AEs, ADRs & SUSARs 
  • 6.4 SAEs and Serious ADRs 
  • 6.5 SUSARs 
  • 6.6 AEs of Special Interest 
  • 6.7 Periodic Safety Reports 
  • 6.8 Reporting Decision Tree 

Chapter 7: Clinical Trial Protocol and Amendments 

  • 7.1 About this Chapter 
  • 7.2 Protocol Content I 
  • 7.3 Protocol Content II 
  • 7.4 Treatment of Subjects 

Chapter 8: Investigator Brochure 

  • 8.1 About this Chapter 
  • 8.2 Table of Contents of Investigator's Brochure (Example) 

Chapter 9: Essential Documents 

  • 9.1 About this Chapter 
  • 9.2 Essential Documents 
  • 9.3 Archiving 
  • 9.4 Documents to be present Pre-Study 
  • 9.5 Documents to be Added During the Study 
  • 9.6 Documents to be Added Post-Study 

Glossary

Common Abbreviations 

Useful Documents 

Useful Links

 

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