ICH GCP adapted for The US in English | Good Clinical Practice Training Course

Whitehall training has continuously worked towards satisfying and supporting a wide spectrum of requirements for ICH-GCP training. Our course is packed with documents, glossary, links and useful tips - all carefully tailored to the US regulatory framework. It covers all international ICH-GCP guidelines and US regulations (21 CFR). It was updated in November 2016 to include the first addendum to the ICh GCP guidelines.

This course has been accredited by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom and awarded 6 cpd points. 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.

Chapter 1: Introduction to GCP 

• 1.1 Background 
• 1.2 What is GCP? 
• 1.3 Why should we have GCP? (ICH GCP/FDA CFR GCP) 
• 1.4 The Basic Principles of FDA and ICH GCP  
• 1.5 The 13 Basic Principles of ICH GCP I 
• 1.6 The 13 Basic Principles of ICH GCP II 
• 1.7 Key ICH Guidelines listed on the FDA’s web site 
• 1.8 Compliance Guidance Manuals 
• 1.9 Impact of ICH GCP in the US 
• 1.10 FDA Acceptance of Foreign Studies I 
• 1.11 FDA Acceptance of Foreign Studies II 
• 1.12 Some General Points 
• 1.13 FDA GCP Regulation 
• 1.14 Documentation and Version Control 
• 1.15 Quality Assurance 
• 1.16 Other Resources 

Chapter 2: FDA and Institutional Review Board (IRB)/Independent Ethics Committee (IRB/IEC) 

• 2.1 About this Chapter 
• 2.2 Introduction 
• 2.3 Responsibilities of the CA 
• 2.4 Responsibility of the IRB/IEC 
• 2.5 Subject Informed Consent Forms I - ICF 
• 2.6 Subject Informed Consent Forms II - The FDA elements of Informed Consent 
• 2.7 Subject Informed Consent Forms III - ICF 
• 2.8 Composition, Functions, Operations, Procedures and Records 
• 2.9 IRB/IEC interactions with Sponsors and Investigators 
• 2.10 FDA’s IRB requirements I 
• 2.11 FDA’s IRB requirements II 
• 2.12 FDA’s IRB requirements III 
• 2.13 Revised guidance on reporting IRB non-compliance I 
• 2.14 Revised guidance on reporting IRB non-compliance II 

Chapter 3: Investigator Responsibilities 

• 3.1 About this Chapter 
• 3.2 What is an Investigator? 
• 3.3 FDA Investigator Responsibilities I 
• 3.4 FDA Investigator Responsibilities II 
• 3.5 FDA Responsibilities of Sponsors and Investigators 
• 3.6 Selecting Investigators and Monitors 
• 3.7 Recordkeeping and Record Retention 
• 3.8 Disposition of Investigational Drug 
• 3.9 Control of the Investigational Drug 
• 3.10 Investigator Records and Reports I 
• 3.11 Investigator Records and Reports II – Study Site Files 
• 3.12 Investigator Records and Reports III 
• 3.13 Investigator Records and Reports IV – Financial Information and Contracts 
• 3.14 Investigator Records and Reports V – The Case Record Form (CRF) 
• 3.15 Investigator Records and Reports VI – Recording Subject Data 
• 3.16 Investigator Records and Reports VII – Progress Reports and Final Report(s) by Investigator 
• 3.17 Investigator Records and Reports VIII – Other Reports Required by the FDA 
• 3.18 Disqualification of a Clinical Investigator I
• 3.19 Disqualification of a Clinical Investigator II – Unreliable Data 
• 3.20 Ineligible Patients 
• 3.21 Adequate Resources 
• 3.22 Medical Care of Trial Subjects 
• 3.23 Communication with IRB/IEC 
• 3.24 Compliance with the Protocol 
• 3.25 Randomization Procedures and Un-blinding 
• 3.26 Informed Consent of Trial Subjects I 
• 3.27 Informed Consent of Trial Subjects II 
• 3.28 Informed Consent of Trial Subjects III – Subjects who Cannot Read or Write 
• 3.29 Informed Consent of Trial Subjects IV – Consenting minors and mentally incompetent subjects 
• 3.30 Informed Consent of Trial Subjects V – Consenting Incapacitated Subjects 
• 3.31 Informed Consent of Trial Subjects VI – Updating Consent 
• 3.32 Premature Termination or Suspension of a Trial 

Chapter 4: Sponsor Responsibilities 

• 4.1 About this Chapter 
• 4.2 Introduction 
• 4.3 ICH Sponsor Responsibilities 
• 4.4 FDA-Specific Sponsor Responsibilities 
• 4.5 Quality Management I 
• 4.6 Quality Management II 
• 4.7 QA and QC (Quality Assurance and Quality Control) 
• 4.8 QA and QC II - SOPs 
• 4.9 QA and QC III - Agreements and Contracts 
• 4.10 Working with Contract Research Organizations (CROs) 
• 4.11 Medical Expertise 
• 4.12 Trial Design  
• 4.13 Trial Management I 
• 4.14 Trial Management II 
• 4.15 Trial Management III - Data Management 
• 4.16 Trial Management IV - Electronic Data Systems 
• 4.17 Trial Management IV - Electronic Source Data 
• 4.18 Trial Management V - Record Keeping 
• 4.19 Trial Management VI - Record Keeping & Record Retention 
• 4.20 Selecting Investigators I 
• 4.21 Selecting Investigators II – Resources 
• 4.22 Selecting Investigators III – Permissions 
• 4.23 Allocation of Responsibilities 
• 4.24 Compensation to Subjects and Investigators 
• 4.25 Financing 
• 4.26 Financing II - The Physician Payment Sunshine Act 
• 4.27 Notification/Submission to FDA/CA 
• 4.28 Investigational New Drug (IND) Application I 
• 4.29 Investigational New Drug (IND) Application II 
• 4.30 Investigational New Drug (IND) Application III 
• 4.31 When an IND is not needed 
• 4.32 Confirmation of Review by IRB/IEC 
• 4.33 Information on IP 
• 4.34 Manufacturing, Packaging, Labeling, and Coding IMP 
• 4.35 Supplying and Handling IP 
• 4.36 Record Access 
• 4.37 Adverse Drug Reaction Reporting 
• 4.38 Monitoring Trial Progress 
• 4.39 Audit I 
• 4.40 Audit II 
• 4.41 Noncompliance 
• 4.42 Premature Termination or Suspension of a Trial 
• 4.43 Clinical Trial/Study Reports 
• 4.44 Multicenter Trials 
• 4.45 Subjects Withdrawing from a Trial 
• 4.46 Compensation When Things Go Wrong 

Chapter 5: Monitor Responsibilities 

• 5.1 About this Chapter 
• 5.2 Introduction 
• 5.3 FDA's Guidance on Risk-Based Monitoring I 
• 5.4 FDA's Guidance on Risk-Based Monitoring II 
• 5.5 FDA's Guidance on Risk-Based Monitoring III 
• 5.6 Monitor’s Responsibilities 
• 5.7 The Monitoring Visit 
• 5.8 Informed Consent I 
• 5.9 Informed Consent II 
• 5.10 Exception from Informed Consent 
• 5.11 Tips for Regulatory Inspections – Common Findings 
• 5.12 Verifying IP/IMP 
• 5.13 Complying with the Protocol, Amendments, SOP and Guidance 
• 5.14 Verifying Informed Consent 
• 5.15 The Case Record Form (CRF) and Source Documents 
• 5.16 Electronic Source Data in Clinical Investigations 
• 5.17 Verifying Subject Data 
• 5.18 Errors in CRFs 
• 5.19 Closing out the Monitoring Visit 
• 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 Sponsor and Investigator Responsibility Decision Tree 
• 6.4 Adverse Events 
• 6.5 Suspected Adverse Reactions 
• 6.6 Adverse Drug Reactions 
• 6.7 SUSARs 
• 6.8 Serious Adverse Events 
• 6.9 Adverse Events of Special Interest 
• 6.10 Ongoing Safety Reports 
• 6.11 IND Safety Reports 
• 6.12 Submission of IND safety reports 
• 6.13 Reporting Results from Foreign Studies 
• 6.14 FDA Guidance for Safety Reporting 

Chapter 7: Clinical Trial Protocol and Amendments 

• 7.1 About this Chapter 
• 7.2 FDA Protocol Requirements 
• 7.3 FDA Protocol Content 
• 7.4 ICH Protocol Content 
• 7.5 New Protocols 
• 7.6 Revised Protocols 

Chapter 8: Investigator Brochure 

• 8.1 About this Chapter 
• 8.2 FDA Investigator Brochure Requirements 
• 8.3 Example IB Table of Contents 

Chapter 9: Essential Documents 

• 9.1 About this Chapter 
• 9.2 Essential Documents 
• 9.3 Investigational New Drug Application 
• 9.4 Statement of Investigator 
• 9.5 FDA Bioresearch Monitoring Program 
• 9.6 Archiving and Submission 
• 9.7 Documents to be Present Pre-Study 
• 9.8 Documents to be Added During the Study 
• 9.9 Documents to be Added Post-Study 

Chapter 10: Additional Draft FDA Guidelines 

• 10.1 About this Chapter 
• 10.2 Use of Electronic Informed Consent in Clinical Investigations - Q&As 
• 10.3 Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors 
• 10.4 FDA Updates Procedures for Approving Emergency Research without Consent 
• 10.5 Exculpatory Language 
• 10.6 Charging for Investigational Drugs 
• 10.7 Enrichment strategies to support approval of drugs / Personalised Medicine development 

Useful Documents 

Useful Contacts 

Glossary 

Common Abbreviations