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1. Introduction & The Principles of ICH GCP
     Introduction
     1.1 Background
     1.2 Structure of ICH
     1.3 ICH Administration
     1.4 The ICH Process for Harmonisation of Guidelines
     1.5 Revised ICH Terms of Reference
     1.6 The Principles of ICH-GCP
     1.7 Conditions and Principles which apply to all Clinical Trials
     Introduction: Key Learning Points
2. Informed Consent
     Introduction
     2.1 Definition of Informed Consent
     2.2 Capable Adults
     2.3 Informing the Patient
     2.4 Informed consent - requirements
     2.5 Principles of the EU Directive for Inclusion of Minors & Incapable Adults in Clinical Trials
     2.6 Definition of a Legal Representative
     2.7 Definition of a Minor
     2.8 Definition of an Incapable Adult
     Consent in Emergency Situation: Statutory Instrument 2006 No. 2984
     2.9 Responsibilities of Ethics Committees in Trials involving Minors or Incapable Adults
     2.10 The Human Tissue Act 2004
     2.11 Who can give Appropriate Consent?
     2.12 Exceptions to Consent
     2.13 Offences and Penalties
     2.14 Mental Capacity Act 2005
     Annex A
     Annex B
     Case Study
     Informed Consent: Key Learning Points
3. Ethics
     Introduction
     IRAS: Integrated Research Application System
     3.1 Responsibilities
     3.2 Composition, Functions and Operations
     3.3 Procedures
     3.4 Records
     3.5 Information sharing
     Ethics: Key Learning Points
4. Investigator Responsibilities
     Introduction
     Responsibilities of Chief Investigator / Principal Investigator
     4.1 Investigator's Qualifications and Agreements
     4.2 Adequate Resources
     4.3 Medical care of Trial Subjects
     4.4 Communication with IRB/IEC
     4.5 Compliance with Protocol
     4.6 Investigational Products
     4.7 Randomisation Procedures and Unblinding
     4.8 Informed Consent of Trial Subjects
     4.9 Records and Reports
     4.10 Progress Reports
     4.11 Safety Reporting
     4.12 Premature Termination or Suspension of a Trial
     4.13 Final Reports
     Case Study
     Investigator Responsibilities: Key Learning Points
5. Sponsor Responsibilities
     Introduction
     Sponsor
     Sponsor Responsibilities / Functions
     5.1 Quality Assurance and Quality Control:
     5.2 Contract Research Organisation (CRO)
     5.3 Medical Expertise
     5.4 Trial Design
     5.5 Trial Management, Data Handling, and Record Keeping
     5.6 Investigator Selection
     5.7 Allocation of Responsibilities
     5.8 Compensation to Subjects and Investigators
     5.9 Financing
     5.10 Notification / Submission to Regulatory Authorities
     5.11 Confirmation of Review by IRB/IEC
     5.12 Information on Investigational Products
     5.13 Manufacturing, Packaging, Labelling, and Coding Investigational Products
     5.14 Supplying and Handling Investigational Products
     5.15 Record Access
     5.16 Safety Information
     5.17 Adverse Drug Reaction Reporting
     5.18 Monitoring
     5.18 Monitoring (continued)
     5.19 Audit
     5.20 Non-compliance
     5.21 Premature Termination or Suspension of a Trial
     5.22 Clinical Trial / Study Reports
     5.23 Notification of Serious Breaches
     5.24 Multi-centre Trials
     5.25 Infringement Notices and Offences
     Case Study
     Sponsor Responsibilities: Key Learning Points
6. Clinical Trial Protocol
     Introduction
     6.1 General Information
     6.2 Background Information
     6.3 Trial Objectives and Purpose
     6.4 Trial Design
     6.5 Selection and Withdrawal of Subjects
     6.6 Treatment of Subject
     6.7 Assessment of Efficacy
     6.8 Assessment of Safety
     6.9 Statistics
     6.10 Direct Access to Source Data/Documents
     6.11 Quality Control and Quality Assurance
     6.12 Ethics
     6.13 Data Handling and Record Keeping
     6.14 Financing and Insurance
     6.15 Publication Policy
     6.16 Supplements
     Clinical Trial Protocol and Protocol Amendments: Key Learning Points
7. Investigator Brochure
     Introduction
     7.1 General Considerations
     7.2 Contents of the Investigators Brochure
     7.2 Contents of the Investigators Brochure - Continued
     Appendix-1
     Appendix-2
     Investigator Brochure: Key Learning Points
8. Essential Documents
     8.1 Introduction
     8.2 Before the Clinical Phase of the Trial Commences
     8.3 During the Clinical Conduct of the Trial
     8.4 After Completion or Termination of the Trial
     Appendix-1
     Case Study
     Essential Documents: Key Learning Points
9. Safety Reporting
     Introduction
     9.1 Investigators Responsibilities
     9.2 Sponsors Responsibilities
     9.3 Recording and Evaluation of Adverse Events (AEs)
     9.4 Reporting of Serious Adverse Reactions (SARs)
     9.5 Adverse reactions/Events in Blinded Trials
     9.6 Adverse Reactions/Events in Trials with High Morbidity and High Mortality Diseases
     9.7 Annual Safety Reports
     9.8 Reporting Time Frame for Annual Safety Report
     9.9 How to Inform Investigators?
     9.10 Reporting of Safety Issues Following Completion of the Clinical Trial in EU
     Case Study
     Safety Reporting: Key Learning Points
 



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