ICH GCP adapted for Australia in English | Australian Good Clinical Practice Training Course

• CPD Points - Gain Continuing Professional Development (CPD) Points that are accredited by the 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 was written by Nick Deaney; who has 30 years' experience up to Research Director level in a major pharma group.

Chapter 1: Introduction to GCP

• 1.1 Background to International GCP 
• 1.2 What is GCP? 
• 1.3 Why should we have ICH-GCP? (Case Scenario) 
• 1.4 The Principles of ICH GCP 
• 1.5 Some General Points 
• 1.6 Documentation and Version Control 
• 1.7 Quality Assurance 
• 1.8 The specifics of GCP in Australia 
• 1.9 Other Resources 

Chapter 2: Competent Authorities (CA) and Human Research Ethics Committees (HRECs) 

• 2.1 About this Chapter 
• 2.2 Introduction 
• 2.3 Responsibilities of the CA (TGA) 
• 2.4 Responsibility of the HREC 
• 2.5 What needs to be checked? 
• 2.6 Subject Informed Consent Forms (ICF) I 
• 2.7 Subject Informed Consent Forms (ICF) II 
• 2.8 Composition, Functions, Operations, Procedures and Records 

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 HREC/IRB 
• 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 - Consent Discussion 
• 3.14 Informed Consent III - Pregnant Women 
• 3.15 Informed Consent IV - Subjects who Cannot Read or Write 
• 3.16 Informed Consent V - Children and young people 
• 3.17 Informed Consent VI - People in unequal or dependent relationships 
• 3.18 Informed Consent VII - Subjects with mental impairment 
• 3.19 Informed Consent VIII - Subjects highly dependent on medical care 
• 3.20 Informed Consent IX - Subjects who may be involved in illegal activities 
• 3.21 Informed Consent X - Aboriginal and Torres Strait Islander peoples 
• 3.22 Informed Consent XI - People in other countries 
• 3.23 Informed Consent XII - Updating consent 
• 3.24 Records and Reports I 
• 3.25 Records and Reports II - Study Site Files 
• 3.26 Records and Reports III 
• 3.27 Records and Reports IV 
• 3.28 Records and Reports V - Financial Information and Contracts 
• 3.29 Records and Reports VI - The Case Record Form (CRF) 
• 3.30 Records and Reports VII - Recording Subject Data 
• 3.31 Premature Termination or Suspension of a Trial 
• 3.32 Progress Reports and Final Report(s) by Investigator 
• 3.33 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 and Contracts 
• 4.8 Contract Research Organisations I 
• 4.9 Contract Research Organisations II 
• 4.10 Trial Design 
• 4.11 Trial Management and Data Handling I - Trial Management 
• 4.12 Trial Management and Data Handling II 
• 4.13 Trial Management and Data Handling III - Data Management 
• 4.14 Trial Management and Data Handling IV - Electronic Data Systems 
• 4.15 Record Keeping 
• 4.16 Investigator Selection I 
• 4.17 Investigator Selection II 
• 4.18 Investigator Selection III - Allocation of Responsibilities 
• 4.19 Investigator Selection IV - Compensation to Subjects and Investigators 
• 4.20 Financing 
• 4.21 Notification/ Submission to Regulatory Authorities 
• 4.22 Gaining TGA approval for Australian trials 
• 4.23 Gaining CA approval in the EU 
• 4.24 Confirmation of Review by HREC/IRB 
• 4.25 Information on IMP 
• 4.26 Manufacturing, Packaging, Labelling and Coding Investigational Products I 
• 4.27 Manufacturing, Packaging, Labelling and Coding Investigational Products II 
• 4.28 Supplying and Handling Investigational Products 
• 4.29 Record Access 
• 4.30 Audit and Inspection 
• 4.31 Noncompliance 
• 4.32 Premature Termination or Suspension of a Trial 
• 4.33 Clinical Trial/Study Reports 
• 4.34 Multicentre Trials 

Chapter 5: Monitor Responsibilities 

• 5.1 About this Chapter 
• 5.2 Introduction 
• 5.3 Monitoring 
• 5.4 Monitor Responsibilities 
• 5.5 The Monitoring Visit 
• 5.6 Verifying IMP 
• 5.7 Complying with the Protocol etc. 
• 5.8 Verifying Informed Consent 
• 5.9 The CRF and Source Documents 
• 5.10 Verifying Subject Data 
• 5.11 Errors in CRFs 
• 5.12 Closing out the Monitoring Visit 
• 5.13 The Monitoring Report & Plan 
• 5.14 Quality Management - Centralized Monitoring 
• 5.15 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 

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

Links