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ICH E6(R3) Good Clinical Practice
Course Summary
Good Clinical Practice (GCP) is an international ethical, scientific and quality standard for the conduct of clinical research. Guideline E6, from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), often referred to as ICH GCP, specifies Good Clinical Practice. Compliance with ICH GCP is expected by regulatory authorities for the authorisation of clinical trials and the acceptance of their data in applications for marketing authorisation. In many countries, compliance with GCP principles is a legal requirement.
In this course, we discuss the role and goals of the ICH, and we present the principles of GCP as set out in the third revision of its guideline E6. We describe the essential records that are to be created and maintained and the expectations for data governance. We specify the responsibilities of trial sponsors and investigators. We explain the rationale and execution of the informed consent process, and discuss issues that arise in practice.
The third revision of ICH GCP, ICH E6(R3), was finalised in January 2025. The guideline has been radically restructured and updated from the previous version. This course is fully up to date with the latest revision.
Purchasing Information
When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.
You will have access to the course module(s) for a period of 180 days after your purchase is complete.
Detailed Course Information
Learning Objectives
• Explain why and how the ICH influences clinical research practice through its guideline on Good Clinical Practice (GCP)
• Identify the principles of GCP
• Identify records essential to a clinical trial, explain their function and use, outline their contents, and describe their maintenance
• Comply with GCP expectations for data governance
• Specify the responsibilities of a trial sponsor
• Specify the responsibilities of a clinical investigator
• Explain the rationale and execution of the informed consent process, and identify issues that arise in practice
• Specify the sponsor’s responsibilities for trial monitoring
Who will benefit from this course
This module will benefit all those who participate in clinical research, whether they work in the pharmaceutical or biotechnology industry or as healthcare professionals. A sound knowledge of GCP is essential for clinical research associates / monitors, project managers, clinical investigators, clinical research coordinators / study nurses, pharmacists, data managers, biostatisticians, and others contributing to clinical trials.
Module Outline
ICH and harmonisation of requirements
Among the many guidance documents developed by the ICH, its guideline E6 on Good Clinical Practice is of major importance to all those involved in clinical research. In this session we describe the ICH’s role in the harmonisation of regulations, and we introduce its guideline E6 in its latest revision, E6(R3).
Principles of Good Clinical Practice
The third revision of ICH GCP has reorganised and expanded the presentation of GCP principles. The principles themselves are now augmented by statements of the key expectations for clinical research conduct that arise from them. In this session, we present the principles and their consequent key expectations in full.
Records and data governance
Rigorous documentation of all aspects of a clinical trial is necessary to provide evidence of GCP and compliance with regulatory requirements, as well as enabling effective management of the trial. In this session, we describe important examples of records expected to be created and maintained in a clinical trial and which ICH GCP considers to be essential to trial conduct. Regulatory inspectors increasingly focus on issues of data integrity, and ICH E6(R3) includes a new section on data governance measures. We describe the implications of the expectations set out in the guideline for the management of data and computerised systems in clinical research.
Sponsor’s responsibilities
The sponsor takes responsibility for the trial’s initiation, management, and the organisation of financing. The responsibility of the sponsor entails the implementation of risk-proportionate approaches to ensure the protection of trial participants and the reliability of trial results throughout the clinical trial life cycle. Added in the third revision of ICH GCP are expectations of the sponsor’s resources, qualifications and training of personnel, agreements (including with service providers), and oversight of trials. In this session, we set out the sponsor’s responsibilities in detail.
Investigator’s responsibilities
The investigator is the person responsible for the conduct of the clinical trial, including care of the participants for whom they have responsibility. In this session, we describe the investigator’s GCP responsibilities for a range of trial aspects, including delegation of responsibilities, communication with IRB/IEC, safety reporting, investigational product management, and records and data.
Informed consent
Informed consent in clinical research is an ethical and regulatory requirement. A research participant must enter a study voluntarily, be informed about risks and benefits, and understand the difference between investigation and treatment. Prospective participants must not be coerced into enrolment, nor must they be enticed by exaggerated claims of benefit. Before they can enrol, all potential participants must agree, in writing, to participate. In this session we set out the underlying principles and ICH GCP expectations and provide examples of practical issues confronting healthcare professionals and participants.
Monitoring
Monitoring is one of the principal quality control activities for a clinical trial. The role of monitoring is evolving, from one focused on investigator site visits and source data verification by monitors, to one embracing a variety of approaches including remote and centralised monitoring and/or in-person visits to investigator sites. In this session, we describe the sponsor’s GCP responsibilities for monitoring of the trial.
Assessment
Multiple-choice mastery assessment.
Roles
Clinical development and regulatory affairs staff of medicinal products companies and service providers such as contract research organisations; healthcare professionals participating in clinical research
CPD Points
Anticipated 3.5 (currently being reviewed by CPD)
Region
Level
Introductory/intermediate
Course Study Time
Approx 3.5 hours
USA, Europe, Other