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Good Clinical Practice training & certification FAQs

GCP stands for Good Clinical Practice

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. The objective of the standard is to ensure that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected, as described in the Declaration of Helsinki, and that the clinical trial data collected, is credible, complete, valid and well documented.

GCP includes all aspects of a clinical trial, since the trial is planned, carried out until the trial results are reported.

This ICH GCP Guidance provides a unified standard for the European Union, Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions. In the event of any conflict between the E6(R1) text and the E6(R2) addendum text, the E6(R2) addendum text should take priority. This means that trials compliant with GCP, will be accepted by regulatory authorities in most countries.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration.

There are 13 principles of ICH GCP and they are as follows:

  • Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
  • Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
  • The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
  • The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
  • Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
  • A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion.
  • The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
  • Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
  • Freely given informed consent should be obtained from every subject prior to clinical trial participation.
  • All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification. ADDENDUM: This principle applies to all records referenced in this guidance, irrespective of the type of media used.
  • The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
  • Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
  • Systems with procedures that assure the quality of every aspect of the trial should be implemented. ADDENDUM: Aspects of the trial that are essential to ensure human subject protection and reliability of trial results should be the focus of such systems.

The first version of ICH E6, or efficacy topic #6 was first approved on June 10th, 1996.

Since the development of the ICH GCP Guidance, the scale, complexity, and cost of clinical trials have increased. Evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities. When the original ICH E6(R1) text was prepared, clinical trials were performed in a largely paper-based process. Advances in use of electronic data recording and reporting facilitate implementation of other approaches. For example, centralized monitoring can now offer a greater advantage, to a broader range of trials than is suggested in the original text. Therefore, this guidance has been amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting while continuing to ensure human subject protection and reliability of trial results. Standards regarding electronic records and essential documents intended to increase clinical trial quality and efficiency have also been updated.

By 2014, ICH created an Expert Working Group (EWG) to update the GCP guideline.

This group completed the first draft by June 2015, and the document was sent out for comments to ICH members and the public. The final text, R2 or also called Addendum, was approved by ICH and published on November 9th, 2016.

It was adopted by the EU on December 2016, and the final version was finally effective on June 2017th

In March 2018, the FDA has adopted the ICH GCP R2.

The International Council for Harmonisation (ICH) is set to revolutionize Good Clinical Practice (GCP) guidelines with the release of the ICH GCP E6 (R3). Unlike its predecessor, E6 (R2), which relied on addendums, E6 (R3) boasts a completely revised structure for improved clarity and readability.

This new structure incorporates:

  • Introduction: Provides a comprehensive overview of the document’s purpose and scope.
  • ICH GCP Principles: Dedicates a full chapter to outlining the core principles of GCP.
  • Annexes:
    • Annex 1: Focuses on the management of interventional clinical trials, with specific sections dedicated to the roles and responsibilities of Institutional Review Boards/Ethics Committees (IRB/IEC), Investigators, Sponsors, and Data Governance (applicable to both Investigators and Sponsors).
    • Annex 2: (availability to be confirmed)
  • Glossary: Expands with new terms, particularly those related to Computer System Validation (CSV) and digitalization (e.g., metadata, data acquisition tools).
  • Appendices: (content details to be confirmed)

The ICH GCP E6 (R3) goes beyond structural improvements, introducing significant content updates:

  • Enhanced Glossary: Provides clearer definitions for existing terms and introduces new ones, reflecting the evolving landscape of clinical research with a focus on digitalization.
  • Clarified Principles: Addresses ambiguities and provides more specific interpretations of existing GCP principles.
  • Electronic Informed Consent (eIC): Acknowledges the growing adoption of electronic informed consent processes and outlines best practices.
  • Quality by Design (QbD) and Risk Mitigation: Strongly emphasizes the implementation of proactive measures to ensure study quality and minimize risks throughout the research process.
  • Sponsor Responsibilities: Clarifies the Sponsor’s role in areas like monitoring, investigational product management, quality management, and oversight.
  • Investigator Responsibilities: Provides more specific guidance on essential record identification and maintenance, timely data review, and delegation of responsibilities to staff.
  • Essential Records: Introduces the distinction between essential records (mandatory for all studies) and potential essential records (implementation based on specific study characteristics).
  • Data Governance: The most significant change, this concept emphasizes shared responsibility between Sponsors and Investigators for data quality, security, and integrity.

The ICH GCP E6 (R3) marks a significant step forward, promoting clarity, digitalization, and data governance in clinical research. By emphasizing proactive quality management and risk mitigation, it fosters an environment for conducting safe, ethical, and scientifically sound clinical trials.

Good Clinical Practice training that demonstrates that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording, and reporting trials that involve human research participants.

To become ICH GCP certified, you must first complete a GCP training course, which can provide you with valuable information about this guidance. It has never been easier to obtain your Good Clinical Practice Certification and become an ICH GCP certified professional!

Whether you are just starting out or want to advance your career, our Good Clinical Practice Training and user-friendly learning platform will make obtaining your Good Clinical Practice Certification easier than ever!.

ICH GCP requires the completion of a training course to demonstrate knowledge and understanding of GCP principles. Participants receive a certificate upon completion. The objective of this Good Clinical Practice Certification is to demonstrate that the clinical research professional has a basic understanding of the regulations and requirements for research using investigational drugs, biologics or devices.

It has never been easier to obtain your Good Clinical Practice Certification and become an ICH GCP certified professional!

The Good Clinical Practice Certificate enables you to conduct ethical clinical studies while safeguarding the rights and safety of human subjects.
Obtaining a certification is the industry standard and is required to demonstrate commitment to compliance and quality assurance, such as for those interested in participating in drug development activities or obtaining funding from research organizations.

Besides, an ICH GCP certification can lead to new career opportunities!

Usually regulatory authorities and auditors/inspectors require Good Clinical Practice training to be refreshed every 3 years. Please check your country’s regulations.

A quiz is also required in order to obtain the Good Clinical Practice Certification. Usually, the passing score is greater than or equal to 80%.

All investigators and staff who are involved in the conduct, oversight, or management of clinical trials are required to complete Good Clinical Practice training.

TransCelerate BioPharma Inc. is a non-profit organization with a mission to collaborate across the biopharmaceutical research and development community to identify, prioritize, design and facilitate the implementation of solutions to drive efficient, effective and high-quality delivery of new medicines, improving the health of people around the world.

Member companies, who are biotech and pharmaceutical companies, have developed guidelines to give hospitals and their investigators peace of mind when it comes to choosing GCP Training Providers.

All Training Providers who can measure Transcelerate minimum criteria are provided in a list, which should be considered by ICH GCP training.

TransCelerate Member Companies have developed guidelines to give innovative drug companies the comfort necessary to accept and rely on Member Companies’ and Training Provider’s investigator site personnel ICH GCP training meeting identified Minimum Criteria.

To be eligible, the GCP training must meet the Minimum Criteria and Program Basic Expectations.  It is expected that the investigator understands and complies with all applicable local and national regulations.

PharmaEduCenter is proudly part of the TransCelerate GCP Mutual Recognition program. This means our ICH E6 GCP Investigator Site Training meets the criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, as necessary to enable mutual recognition of GCP training among trial sponsors.

This TransCelerate initiative helps reduce the time spent on GCP training. This makes the lives of researchers, clinicians, and their staff, easier, by increasing efficiency during site initiations and ongoing of clinical trials.

If you are a clinical Investigator conducting trials for multiple sponsors, our global accepted GCP training will not have to be repeated. This means, you can focus then, on conducting a quality research improving human health.

Although they are both vital to the development of medicine, clinical and medical research have different goals and purviews.

Any research that attempts to deepen our understanding of human health and disease is included under the broad category of medical research. Among other sorts of studies, it might include population-level research, epidemiological studies, or simple laboratory research. Identifying the underlying causes of disease, creating new diagnostic instruments, or investigating novel treatment approaches are all common goals of medical research.

Contrarily, clinical research is a branch of medical research that focuses on investigating novel medications, therapies, or interventions in human subjects. Clinical research can involve conducting clinical trials to test novel medications, medical devices, or procedures. It frequently entails conducting meticulously controlled studies to evaluate the side effects, efficacy, and safety of these interventions.

If a person is interested in investigating more general issues regarding human health and illness, such as comprehending the underlying mechanisms of a disease or determining risk factors for a specific condition, they may opt for medical research over clinical research. On the other hand, if a person is eager to test a novel intervention on humans in order to ascertain its efficacy and safety, they might opt for clinical research.

For the purpose of expanding our knowledge of human health and disease and enhancing medical treatment, both clinical and medical research are essential. Together, these complimentary methods enhance patient outcomes and progress medicine.

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