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).

This course has been accredited by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom and awarded 7 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

·         The History of GCP

·         What is GCP?

·         Why should we have GCP? (A quick quiz)

·         The Basic Principles of FDA and ICH GCP

·         The 13 Basic Principles of ICH GCP

·         Key ICH Guidelines listed on the FDA’s web site

·         Compliance Guidance Manuals

·         Certificate of Confidentiality

·         FDA Inspections

·         US/EMEA GCP Inspection Agreement

·         FDA GCP Compliance

·         Impact of ICH GCP in the US

·         FDA Acceptance of Foreign Studies

·         Some General Points

·         FDA GCP Regulation

·         Important Practical Considerations

·         Other Resources

·         Introduction to GCP - Webinar

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

·         About this Chapter

·         Introduction

·         GCP During the Pandemic

·         Responsibilities of the CA

·         Responsibility of the IRB/IEC

·         Subject Informed Consent Forms (ICF)

·         IRB/IEC Composition, Functions, Operations, Procedures and Records

·         IRB/IEC interactions with Sponsors and Investigators

·         FDA’s IRB requirements

·         Revised guidance on reporting IRB non-compliance

Chapter 3: Investigator Responsibilities

·         About this Chapter

·         What is an Investigator?

·         FDA Investigator Responsibilities

·         Selecting Investigators and Monitors

·         Recordkeeping and Record Retention

·         Disposition of Investigational Drug

·         Investigator Records and Reports - (Trial Master File)

·         Investigator Records and Reports - (Study Site Files)

·         Investigator Records and Reports – (Source Documents)

·         Investigator Records and Reports - (Financial Information and Contracts)

·         Investigator Records and Reports - (The Case Record Form - CRF)

·         Investigator Records and Reports – (Recording Subject Data)

·         Investigator Records and Reports - (Progress Reports and Final Report(s) by Investigator)

·         Investigator Records and Reports - (Safety Reports)

·         Investigator Records and Reports - (Assurance of IRB review)

·         Investigator Records and Reports - (Inspection of investigator's records and reports)

·         Investigator Records and Reports - (Handling of controlled substances)

·         Disqualification of a Clinical Investigator

·         Disqualification of a Clinical Investigator - (Actions upon disqualification)

·         Disqualification of a Clinical Investigator - (Disclosure of disqualification actions)

·         Disqualification of a Clinical Investigator - (Information sheet)

·         Disqualification of a Clinical Investigator - (Reinstatement of a disqualified investigator)

·         Disqualification of a Clinical Investigator - (Unreliable data)

·         Ineligible Patients

·         Adequate Resources

·         Medical Care of Trial Subjects

·         Communication with IRB/IEC

·         Compliance with the Protocol

·         Randomization Procedures and Un-blinding

·         Informed Consent of Trial Subjects

·         Informed Consent of Trial Subjects - (The Consent Discussion)

·         Informed Consent of Trial Subjects - (Subjects who cannot read or write)

·         Informed Consent of Trial Subjects - (Consenting minors and mentally incompetent subjects)

·         Informed Consent of Trial Subjects - (Consenting Incapacitated Subjects)

·         Informed Consent of Trial Subjects - (Updating Consent)

·         Premature Termination or Suspension of a Trial

Chapter 4: Sponsor Responsibilities

·         About this Chapter

·         Introduction

·         ICH Sponsor Responsibilities

·         FDA-Specific Sponsor Responsibilities

·         FDA-Specific Sponsor Responsibilities - (Form FDA 1572)

·         FDA-Specific Sponsor Responsibilities - (Further considerations)

·         Quality Management

·         QA and QC (Quality Assurance and Quality Control)

·         QA and QC (Quality Assurance and Quality Control) - (SOPs)

·         QA and QC (Quality Assurance and Quality Control) - (Agreements and Contracts)

·         Working with Contract Research Organizations (CROs)

·         Medical Expertise

·         Trial Design

·         Enrichment strategies to support approval of drugs / Personalized Medicine development

·         Trial Management

·         Trial Management - (Data Management)

·         Trial Management - (Electronic Data Systems)

·         Trial Management - (Record Keeping)

·         Trial Management - (Record Keeping - FDA Inspections)

·         Trial Management - (Record Keeping & Record Retention)

·         Selecting Investigators

·         Selecting Investigators - (Resources)

·         Selecting Investigators -  (Permissions)

·         Allocation of Responsibilities

·         Compensation to Subjects and Investigators

·         Financing

·         Financing - (The Physician Payment Sunshine Act)

·         Notification/Submission to FDA/CA

·         Investigational New Drug (IND) Application - (When an IND is required)

·         Investigational New Drug (IND) Application - (Types of IND)

·         Investigational New Drug (IND) Application

·         When an IND is not needed

·         Confirmation of Review by IRB/IEC

·         Information on IP

·         Manufacturing, Packaging, Labeling, and Coding IMP

·         Supplying and Handling Investigational Products

·         Record Access

·         Adverse Drug Reaction Reporting

·         Monitoring Trial Progress

·         Audit

·         Audit - (Videos)

·         Noncompliance

·         Premature Termination or Suspension of a Trial

·         Clinical Trial/Study Reports

·         Multicenter Trials

·         Enhancing the Diversity of Clinical Trial Populations

·         Subjects Withdrawing from a Trial

·         Compensation When Things Go Wrong - (The TeGenero Incident)

·         Compensation When Things Go Wrong

Chapter 5: Monitor Responsibilities

·         About this Chapter

·         Introduction

·         FDA's Guidance on Risk-Based Monitoring

·         FDA's Guidance on Risk-Based Monitoring - (Centralized Monitoring)

·         FDA's Guidance on Risk-Based Monitoring - (The Monitoring Plan)

·         Monitor’s Responsibilities

·         The Monitoring Visit

·         The Monitoring Visit - (Responsibilities)

·         Informed Consent

·         Electronic Informed Consent

·         Electronic Informed Consent - (FDA Inspections)

·         Exception from Informed Consent

·         Tips for Regulatory Inspections – Common Findings

·         Verifying IP/IMP

·         Complying with the Protocol, Amendments, SOP and Guidance

·         Verifying Informed Consent

·         The Case Record Form (CRF) and Source Documents

·         Electronic Source Data in Clinical Investigations

·         Verifying Subject Data

·         Errors in CRFs

·         Closing out the Monitoring Visit

·         The Monitoring Report & Plan

·         Fraud and Misconduct

·         Fraud and Misconduct - (The KETEK case)

Chapter 6: Safety & Adverse Event Reporting

·         About this Chapter

·         Introduction

·         Introduction - (FDA Guidance)

·         Sponsor and Investigator Responsibility Decision Tree

·         Adverse Events

·         Suspected Adverse Reactions

·         Adverse Drug Reactions

·         Suspected Unexpected Serious Adverse Reactions  (SUSARs)

·         Serious Adverse Events

·         Adverse Events of Special Interest

·         Ongoing Safety Reports

·         IND Safety Reports

·         Submission of IND safety reports

·         Submission of IND safety reports - (Reporting study end points)

·         Reporting Results from Foreign Studies

·         FDA Guidance for Safety Reporting

Chapter 7: Clinical Trial Protocol and Amendments

·         About this Chapter

·         Introduction

·         FDA Protocol Requirements

·         FDA Protocol Content

·         ICH Protocol Content - pt 1 (General Information)

·         ICH Protocol Content - pt 2 (Background and Trial Objectives)

·         ICH Protocol Content - pt 3 (Trial Design)

·         ICH Protocol Content - pt 4 (Selection and Withdrawal of Subjects)

·         ICH Protocol Content - pt 5 (Treatment of Subjects and Assessment of Efficacy)

·         ICH Protocol Content - pt 6 (Assessment of Safety and Statistics)

·         ICH Protocol Content - pt 7 (Other Content)

·         New Protocols

·         Revised Protocols

Chapter 8: Investigator Brochure

·         About this Chapter

·         Introduction

·         FDA Investigator Brochure Requirements

·         FDA Investigator Brochure Requirements - (Informing Investigators)

·         Example IB Table of Contents

Chapter 9: Essential Documents

·         About this Chapter

·         Essential Documents

·         Investigational New Drug Application

·         Statement of Investigator

·         FDA Bioresearch Monitoring Program

·         Penalties

·         Archiving and Submission

·         Documents to be Present Pre-Study

·         Documents to be Added During the Study

·         Documents to be Added Post-Study

Useful Documents

·         Useful Documents

·         Useful Contacts

·         Glossary

·         Common Abbreviations

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