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

• 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 8 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.

Chapter 1: Introduction

• 1.1 The History of GCP - pt 1 
• 1.2 The History of GCP - pt 2 
• 1.3 What is GCP? 1.4 GCP - Introduction (Mini-exam) 
• 1.5 How was GCP introduced into the UK? 
• 1.6 The Principles of GCP 
• 1.7 Some General Points 
• 1.8 Documentation and Version Control 
• 1.9 Quality Assurance 
• 1.10 MHRA GCP inspections 
• 1.11 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 (Mini-exam) 
• 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 
• 3.5 Investigator's Qualifications and Agreements (Mini-exams) 
• 3.6 Adequate Resources 
• 3.7 Adequate Resources (Mini-exams) 
• 3.8 Medical Care of Trial Subjects I 
• 3.9 Medical Care of Trial Subjects II (Mini-exams) 
• 3.10 Medical Care of Trial Subjects III 
• 3.11 Communication with IRB/IEC I 
• 3.12 Communication with IRB/IEC (Mini-exams) 
• 3.13 Compliance with the Protocol 
• 3.14 Compliance with the Protocol (Mini-exams) 
• 3.15 Investigational Medicinal Product 
• 3.16 Investigational Medicinal Product (Mini-exams) 
• 3.17 Randomization Procedures and Un-blinding 
• 3.18 Randomization Procedures (Mini-exam) 
• 3.19 Informed Consent I 
• 3.20 Informed Consent II (Mini-exams) 
• 3.21 Informed Consent III - The Consent Discussion 
• 3.22 Informed Consent IV - Vulnerable Patients 
• 3.23 Informed Consent V (Mini-exams) 
• 3.24 Informed Consent VI - Subjects who Cannot Read or Write 
• 3.25 Informed Consent VII - Minors and "Incompetent" Patients 
• 3.26 Informed Consent VIII (Mini-exam) 
• 3.27 Informed Consent IX - Incapacitated Subjects 
• 3.28 Informed Consent X (Mini-exam) 
• 3.29 Informed Consent XI - Updating Consent 
• 3.30 Records and Reports I 
• 3.31 Records and Reports II - Study Site Files 
• 3.32 Records and Reports III - Updates & Amendments 
• 3.33 Records and Reports IV - Source Documents 
• 3.34 Records and Reports V (Mini-exams) 
• 3.35 Records and Reports VI - Financial Information & Contracts 
• 3.36 Records and Reports VII (Mini-exam) 
• 3.37 Records and Reports VIII - The Case Record Form (CRF) 
• 3.38 Records and Reports IX - Recording Subject Data 
• 3.39 Records and Reports X (Mini-exams) 
• 3.40 Premature Termination or Suspension of a Trial 
• 3.41 Progress & Final Reports by Investigator 
• 3.42 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 (Mini-exam) 
• 4.7 QA and QC III - Standard Operating Procedures 
• 4.8 QA and QC IV (Mini-exam) 
• 4.9 QA and QC V - Agreements & Contracts 
• 4.10 QA and QC VI (Mini-exam) 
• 4.11 Contract Research Organisations I 
• 4.12 Contract Research Organisations II 
• 4.13 Medical Expertise 
• 4.14 Trial Design 
• 4.15 Trial Management I 
• 4.16 Trial Management II (Mini-exam) 
• 4.17 Trial Management III - Data Management
• 4.18 Trial Management IV (Mini-exam) 
• 4.19 Trial Management V - Electronic Data Systems 
• 4.20 Trial Management VI (Mini-exam) 
• 4.21 Trial Management VII - Record Keeping 
• 4.22 Trial Management VIII (Mini-exam) 
• 4.23 Investigator Selection I 
• 4.24 Investigator Selection II (Mini-exams) 
• 4.25 Investigator Selection III - Gaining Permissions 
• 4.26 Investigator Selection IV (Mini-exam) 
• 4.27 Investigator Selection V - Allocation of Responsibilities 
• 4.28 Investigator Selection VI - Compensation 
• 4.29 Investigator Selection VII (Mini-exam) 
• 4.30 Financing 
• 4.31 Notification/Submission to Authorities I 
• 4.32 Notification/Submission to Authorities II - Gaining CA approval in the EU 
• 4.33 Notification/Submission to Authorities III (Mini-exams) 
• 4.34 Confirmation of Review by IRB/IEC 
• 4.35 Confirmation of Review by IRB/IEC (Mini-exam) 
• 4.36 Information on IMP 
• 4.37 Manufacturing, Packaging, Labelling and Coding Investigational Products I 
• 4.38 Manufacturing, Packaging, Labelling and Coding Investigational Products II 
• 4.39 Manufacturing, Packaging, Labelling and Coding Investigational Products III (Mini-exams) 
• 4.40 Supplying and Handling Investigational Products I 
• 4.41 Supplying and Handling Investigational Products II (Mini-exam) 
• 4.42 Record Access 
• 4.43 Audit and Inspection 
• 4.44 Noncompliance 
• 4.45 Premature Termination or Suspension of a Trial 
• 4.46 Clinical Trial/Study Reports 
• 4.47 Multicentre Trials 

Chapter 5: Monitor Responsibilities 

• 5.1 About this Chapter 
• 5.2 Introduction 
• 5.3 Monitoring 
• 5.4 Monitor's Responsibilities 
• 5.5 The Monitoring Visit 
• 5.6 Monitoring (Mini-exam) 
• 5.7 Verifying IMP 
• 5.8 Monitoring (Mini-exams) 
• 5.9 Complying with the Protocol, Amendments, SOPs & Guidance 
• 5.10 Verifying Informed Consent 
• 5.11 Monitoring (Mini-exams) 
• 5.12 The CRF & Source Documents 
• 5.13 Verifying Subject Data 
• 5.14 Verifying Subject Data (Mini-exams) 
• 5.15 Errors in CRFs 
• 5.16 Errors in CRFs (Mini-exam) 
• 5.17 Closing out the Monitoring Visit 
• 5.18 The Monitoring Report & Plan 
• 5.19 Quality Management - Centralized Monitoring 
• 5.20 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 (Mini-exam) 
• 6.5 SAEs & Serious ADRs 
• 6.6 Adverse Drug Reaction Reporting (Mini-exams) 
• 6.7 SUSARs 
• 6.8 Adverse Drug Reaction Reporting (Mini-exam) 
• 6.9 AEs of Special Interest 
• 6.10 Periodic Safety Reports 
• 6.11 Reporting Decision Tree 

Chapter 7: Clinical Trial Protocol and Amendments 

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

Chapter 8: Investigator Brochure 

• 8.1 About this Chapter 
• 8.2 Managing an Investigator Brochure (Mini-exam) 
• 8.3 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 Archiving (Mini-exam) 
• 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