ICH-GCP Training - Qualify Today!
Good Clinical Practice training courses online 
person

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

UK Good Clinical Practice (GCP) Interactive Online Training Course - featuring mini-exams designed to help the trainee assess the GCP rules in real life situations. Updated Nov 2016.

This Good Clinical Practice (GCP) course is a comprehensive guide to ICH-GCP principles and their practical application in the workplace. You will learn how to apply them in your work on a daily basis. 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. This GCP course is essential for those new to clinical research or experienced staff from the NHS, University Hospitals, Pharma, CROs and research institutes, investigators, clinical trials support staff, research nurses and ethics committee members. Updated with ICH E6 (R2) in Nov 2016.

  • Average study time:
    study time

    9 hrs

  • Personal development points (CPD):
    points

    9 points

  • Price:
    points

    £69.00

Please enter the number of licences required.

Course Details

  • Interactive with a clear, attractive format.
  • You can solve problems as you work through the course to reinforce your learning.
  • Easily cross reference to the ICH-GCP E6 document.
  • Multiple choice questions throughout the course prepare you for the exam.
  • Gain useful insights into the application of GCP from the author's vast experience.
  • Carries 9 CPD points and accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom.

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? (Mini-exam) 
  • 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 Subject Informed Consent Forms (ICF) III (Case Scenario) 
  • 2.8 Composition, Functions, Operations, Procedures and Records 
  • 2.9 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 I 
  • 3.5 Investigator Qualifications and Agreements II (Case Scenario) 
  • 3.6 Adequate Resources I 
  • 3.7 Adequate Resources II (Case Scenario) 
  • 3.8 Adequate Resources III (Case Scenario) 
  • 3.9 Medical Care of Trial Subjects I 
  • 3.10 Medical Care of Trial Subjects II (Case Scenario) 
  • 3.11 Medical Care of Trial Subjects III (Case Scenario) 
  • 3.12 Medical Care of Trial Subjects IV 
  • 3.13 Communication with IRB/IEC I 
  • 3.14 Communication with IRB/IEC II (Case Scenario) 
  • 3.15 Communication with IRB/IEC III (Case Scenario) 
  • 3.16 Communication with IRB/IEC IV (Case Scenario) 
  • 3.17 Compliance with the Protocol I 
  • 3.18 Compliance with the Protocol II (Case Scenario) 
  • 3.19 Compliance with the Protocol III (Case Scenario) 
  • 3.20 Compliance with the Protocol IV (Case Scenario) 
  • 3.21 Investigational Medicinal Product I (Case Scenario) 
  • 3.22 Investigational Medicinal Product II (Case Scenario) 
  • 3.23 Investigational Medicinal Product III (Case Scenario) 
  • 3.24 Investigational Medicinal Product IV (Case Scenario) 
  • 3.25 Randomization Procedures and Un-blinding 
  • 3.26 Randomization Procedures (Case Scenario) 
  • 3.27 Informed Consent I 
  • 3.28 Informed Consent II (Case Scenario) 
  • 3.29 Informed Consent III (Case Scenario) 
  • 3.30 Informed Consent IV - The Consent Discussion 
  • 3.31 Informed Consent V - Vulnerable Patients 
  • 3.32 Informed Consent VI (Case Scenario) 
  • 3.33 Informed Consent VII (Case Scenario) 
  • 3.34 Informed Consent VIII - Subjects who Cannot Read or Write 
  • 3.35 Informed Consent IX - Minors and "Incompetent" Patients 
  • 3.36 Informed Consent X (Case Scenario) 
  • 3.37 Informed Consent XI - Incapacitated Subjects 
  • 3.38 Informed Consent XII (Case Scenario) 
  • 3.39 Informed Consent XIII - Updating Consent 
  • 3.40 Records and Reports I 
  • 3.41 Records and Reports II - Study Site Files 
  • 3.42 Records and Reports III - Updates & Amendments 
  • 3.43 Records and Reports IV - Source Documents 
  • 3.44 Records and Reports V (Case Scenario) 
  • 3.45 Records and Reports VI (Case Scenario) 
  • 3.46 Records and Reports VII - Financial Information & Contracts 
  • 3.47 Records and Reports VIII (Case Scenario) 
  • 3.48 Records and Reports IX - The Case Record Form (CRF) 
  • 3.49 Records and Reports X - Recording Subject Data 
  • 3.50 Records and Reports XI (Case Scenario) 
  • 3.51 Records and Reports XII (Case Scenario) 
  • 3.52 Premature Termination or Suspension of a Trial 
  • 3.53 Progress & Final Reports by Investigator 
  • 3.54 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 QA and QC (Quality Assurance and Quality Control) I 
  • 4.6 QA and QC II (Case Scenario) 
  • 4.7 QA and QC III - SOPs 
  • 4.8 QA and QC IV (Case Scenario) 
  • 4.9 QA and QC V - Agreements & Contracts 
  • 4.10 QA and QC VI (Case Scenario) 
  • 4.11 Contract Research Organisations I (Case Scenario) 
  • 4.12 Contract Research Organisations II (Case Scenario) 
  • 4.13 Medical Expertise (Case Scenario) 
  • 4.14 Trial Design 
  • 4.15 Trial Management I 
  • 4.16 Trial Management II (Case Scenario) 
  • 4.17 Trial Management III - Data Management 
  • 4.18 Trial Management IV (Case Scenario) 
  • 4.19 Trial Management V - Electronic Data Systems 
  • 4.20 Trial Management VI (Case Scenario) 
  • 4.21 Trial Management VII - Record Keeping 
  • 4.22 Trial Management VIII (Case Scenario) 
  • 4.23 Investigator Selection I 
  • 4.24 Investigator Selection II (Case Scenario) 
  • 4.25 Investigator Selection III (Case Scenario) 
  • 4.26 Investigator Selection IV (Case Scenario) 
  • 4.27 Investigator Selection V - Gaining Permissions 
  • 4.28 Investigator Selection VI (Case Scenario) 
  • 4.29 Investigator Selection VII - Allocation of Responsibilities 
  • 4.30 Investigator Selection VIII - Compensation 
  • 4.31 Investigator Selection IX (Case Scenario) 
  • 4.32 Financing 
  • 4.33 Notification/Submission to Authorities I 
  • 4.34 Notification/Submission to Authorities II - Gaining CA approval in the EU 
  • 4.35 Notification/Submission to Authorities III (Case Scenario) 
  • 4.36 Notification/Submission to Authorities IV (Case Scenario) 
  • 4.37 Notification/Submission to Authorities V (Case Scenario) 
  • 4.38 Confirmation of Review by IRB/IEC I 
  • 4.39 Confirmation of Review by IRB/IEC II (Case Scenario) 
  • 4.40 Information on IMP I (Case Scenario) 
  • 4.41 Manufacturing, Packaging, Labelling and Coding Investigational Products I 
  • 4.42 Manufacturing, Packaging, Labelling and Coding Investigational Products II (Case Scenario) 
  • 4.43 Manufacturing, Packaging, Labelling and Coding Investigational Products III (Case Scenario) 
  • 4.44 Supplying and Handling Investigational Products I 
  • 4.45 Supplying and Handling Investigational Products II (Case Scenario) 
  • 4.46 Supplying and Handling Investigational Products III (Case Scenario) 
  • 4.47 Record Access (Case Scenario) 
  • 4.48 Audit and Inspection (Case Scenario) 
  • 4.49 Noncompliance 
  • 4.50 Premature Termination or Suspension of a Trial 
  • 4.51 Clinical Trial/Study Reports 
  • 4.52 Multicentre Trials 

Chapter 5: Monitor Responsibilities 

  • 5.1 About this Chapter 
  • 5.2 Introduction 
  • 5.3 Monitoring (Case Scenario) 
  • 5.4 Monitor's Responsibilities 
  • 5.5 The Monitoring Visit 
  • 5.6 Monitoring (Case Scenario) 
  • 5.7 Verifying IMP 
  • 5.8 Monitoring (Case Scenario) 
  • 5.9 Monitoring (Case Scenario) 
  • 5.10 Complying with the Protocol, Amendments, SOPs & Guidance (Case Scenario) 
  • 5.11 Verifying Informed Consent 
  • 5.12 Monitoring (Case Scenario) 
  • 5.13 Monitoring (Case Scenario) 
  • 5.14 The CRF & Source Documents 
  • 5.15 Verifying Subject Data 
  • 5.16 Monitoring (Case Scenario) 
  • 5.17 Errors in CRFs 
  • 5.18 Monitoring (Case Scenario) 
  • 5.19 Closing out the Monitoring Visit (Case Scenario) 
  • 5.20 The Monitoring Report & Plan 
  • 5.21 Quality Management - Centralized Monitoring 
  • 5.22 Fraud and Misconduct 

Chapter 6: Safety & Adverse Event Reporting 

  • 6.1 About this Chapter 
  • 6.2 Introduction 
  • 6.3 AEs, ADRs & SUSARs 
  • 6.4 Adverse Drug Reaction Reporting (Case Scenario) 
  • 6.5 SAEs & Serious ADRs 
  • 6.6 Adverse Drug Reaction Reporting (Case Scenario) 
  • 6.7 Adverse Drug Reaction Reporting (Case Scenario) 
  • 6.8 SUSARs 
  • 6.9 Adverse Drug Reaction Reporting (Case Scenario) 
  • 6.10 AEs of Special Interest 
  • 6.11 Periodic Safety Reports 
  • 6.12 Reporting Decision Tree 

Chapter 7: Clinical Trial Protocol and Amendments 

  • 7.1 About this Chapter 
  • 7.2 Writing a Protocol (Case Scenario) 
  • 7.3 Protocol Content I 
  • 7.4 Protocol Content II - Selection & Withdrawal of Subjects 
  • 7.5 Treatment of Subjects 
  • 7.6 Protocol Content (Case Scenario) 

Chapter 8: Investigator Brochure 

  • 8.1 About this Chapter 
  • 8.2 Managing an Investigator Brochure (Case Scenario) 
  • 8.3 Table of Contents of Investigator's Brochure (Example) 

Chapter 9: Essential Documents 

  • 9.1 About this Chapter 
  • 9.2 Essential Documents (Case Scenario) 
  • 9.3 Archiving I 
  • 9.4 Archiving II (Case Scenario) 
  • 9.5 Documents to be present Pre-Study 
  • 9.6 Documents to be Added During the Study 
  • 9.7 Documents to be Added Post-Study 

Glossary 

Common Abbreviations 

Useful Documents 

Links

 

Novartis logo                        NHS logo                        Takeda logo                        Roche logo                        DHL logo                        Baxter logo                        Quintiles logo                        King's College logo                        US AID logo                        Novo Nordisk logo                           Grunenthal logo                           Wellcome logo                           Ipsen logo                           BTG logo                           
  • 21,183 STUDENTS
  • 9,400 COMPANIES
  • 40 COUNTRIES
  • AND COUNTING.....