ICH GCP in English | Good Clinical Practice Training Course

• Fully compliant – This course meets the required standard for basic GCP training, allowing learners to work on clinical trials. Learners also receive 6 Continuing Professional Development (CPD) Points awarded 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.
• Certified – All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from database, re-sitting the exam doesn’t mean taking the same questions again and again.
• Affordable – Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training.  We can also offer generous group discounts on larger purchases.
• Time-saving – Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training. 

Chapter 1: Introduction to GCP

• 1.1 The History of GCP - pt 1
• 1.2 The History of GCP - pt 2
• 1.3 What is GCP? 
• 1.4 Why should we have ICH-GCP? (Mini exam) 
• 1.5 The Principles of ICH GCP 
• 1.6 Some General Points 
• 1.7 Documentation and Version Control 
• 1.8 Quality Assurance (QA) 
• 1.9 Other Resources
• 1.10 Introduction to GCP - Webinar 

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 the 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 Qualifications and Agreements 
• 3.5 Adequate Resources 
• 3.6 Medical Care of Trial Subjects I 
• 3.7 Medical Care of Trial Subjects II 
• 3.8 Communication with IRB/IEC 
• 3.9 Compliance with the Protocol 
• 3.10 Investigational Medicinal Product 
• 3.11 Randomization Procedures and Un-blinding 
• 3.12 Informed Consent I 
• 3.13 Informed Consent II - The Consent Discussion 
• 3.14 Informed Consent III - Subjects who Cannot Read or Write 
• 3.15 Informed Consent IV - Minors and "mentally incompetent" subjects 
• 3.16 Informed Consent V - Incapacitated Subjects
• 3.17 Informed Consent VI - 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 and 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 Reports and Final Report(s) 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 QA and QC (Quality Assurance and Quality Control) I 
• 4.6 QA and QC II - Standard Operating Procedures 
• 4.7 QA and QC 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 Information on IMP 
• 4.23 Manufacturing, Packaging, Labelling and Coding Investigational Products I 
• 4.24 Manufacturing, Packaging, Labelling and Coding Investigational Products II 
• 4.25 Supplying and Handling Investigational Products 
• 4.26 Record Access 
• 4.27 Audit and Inspection 
• 4.28 Noncompliance 
• 4.29 Premature Termination or Suspension of a Trial 
• 4.30 Clinical Trial/Study Reports 
• 4.31 Multicentre Trials 

Chapter 5: Monitor Responsibilities 

• 5.1 About this Chapter 
• 5.2 Introduction 
• 5.3 Monitoring 
• 5.4 The Monitoring Visit
• 5.5 Verifying IMP 
• 5.6 Complying with the Protocol, Amendments, SOP and Guidance 
• 5.7 Verifying Informed Consent 
• 5.8 The Case Record Form (CRF) and Source Documents 
• 5.9 Verifying Subject Data 
• 5.10 Errors in CRFs 
• 5.11 Closing out the Monitoring Visit 
• 5.12 The Monitoring Report & Plan 
• 5.13 Quality Management - Centralized Monitoring 
• 5.14 Fraud and Misconduct 

Chapter 6: Safety & Adverse Event Reporting 

• 6.1 About this Chapter 
• 6.2 Introduction 
• 6.3 AEs, ADRs & SUSARs 
• 6.4 Serious Adverse Events 
• 6.5 SUSARs 
• 6.6 Adverse Events 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 Introduction 
• 7.3 Protocol Structure and Content I
• 7.4 Protocol Structure and Content II
• 7.5 Protocol Structure and Content III

Chapter 8: Investigator Brochure 

• 8.1 About this Chapter 
• 8.2 Introduction 
• 8.3 Investigator Brochure Structure and Content 

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