Good clinical practice (GCP) in clinical trials
Have you ever wondered how clinical trials ensure the safety and rights of their participants while producing reliable data for new treatments?
The answer lies in good clinical practice (GCP): a globally recognised standard that forms the foundation of ethical and scientific integrity in clinical research. Whether you're a seasoned researcher or just curious about how clinical trials work behind the scenes, understanding GCP is crucial.
This article will cover the key principles of GCP, its history, how it's implemented in Australia, and why it matters so much to clinical trial participants and organisers.
Good clinical practice for investigator-led clinical trials: A quick summary
- Good clinical practice (GCP) is an internationally recognised standard for conducting clinical trials involving human participants
- all members of your trial team must complete mandatory GCP training
- you can access training providers via the links in this article or through your local resources or sponsor.
Read on to learn about GCP in more detail.
Firstly, what is good clinical practice (GCP)?
Good clinical practice (GCP) is an internationally recognised standard for conducting clinical trials involving human participants. This ethical and scientific quality standard outlines the way in which clinical trial teams design, conduct, record and report on clinical trials.
The purpose of good clinical practice guidelines is to ensure the well-being safety of participants while upholding their rights. Beyond protecting human subjects, it also ensures trials are conducted in a credible, consistent and reliable way – leading to better outcomes for all.
As a unified global ethical and scientific framework, it guides the responsibilities and expectations of all key stakeholders in the clinical trial process – including sponsors, investigators, monitors, and the Human Research Ethics Committee (HREC). Beyond this, it also includes the requirements for other factors like trial documentation, indemnity, medical care for trial participants, reporting adverse effects, protocol changes and more.
Overall, GCP is an essential and important part of clinical trials in Queensland, Australia, and across the globe, as they strive for high standards, data integrity, participant safety, and, ultimately, the development of new and effective treatments.
The history of GCP
Good clinical practice has a global history, dating back to the Nuremberg Code in 1947 – a code that was established in response to unethical medical experiments conducted during World War II.
The Nuremberg Code was instrumental in introducing concepts such as voluntary consent. The aim of the code is to avoid any unnecessary suffering or harm of research participants.
When the World Medical Association adopted the Declaration of Helsinki in 1964, this further refined the ethical standards of human research. The Declaration focused on the importance of consent as well as independent ethical review. During this time, clinical trials began to rise in frequency across the world, and a need for consistent guidelines became increasingly apparent.
During the 1980s, efforts to standardise clinical trial practices were increasing. Ultimately, the International Conference on Harmonisation (ICH) was formed in 1990, which was a collaborative initiative that included regulatory authorities and pharmaceutical industry representatives from the United States, Europe, and Japan.
The ICH released GCP E6 guidelines in 1996 which were a unified standard for ethical and scientific quality of clinical trials. The GCP E6 guidelines covered the responsibilities of sponsors, investigators and ethics committees with the goal of ensuring high standards of integrity and the protection of participants.
Since its introduction, the ICH GCP guidelines have been revised to address advancements in research. A notable update was in 2016 (GCP E6, R2) which focused on enhanced risk management and quality management processes – specifically to data integrity and participant safety and a further update in 2025 (GCP E6, R3) focussing on risk-based approaches, technology integration and enhanced transparency and oversight.
Overall, GCP continues to evolve and provides a consistent and globally recognised set of ethical and scientific standards. When implemented, the standards of practice contribute to the safety and well-being of participants as well as the integrity of data and accuracy of results.
Good clinical practice guidelines in Australia
Australia adopted the ICH GCP guidelines in 1997. With this recognition, Australia aligned its clinical trial practices with international standards and enhanced the credibility and safety of its clinical research.
The Australian Therapeutic Goods Administration (TGA) has adopted several ethics standards to ensure compliance in Australia. This includes:
- the European ICH Guideline for Good Clinical Practice. There are notes added by the TGA to add context within the Australian setting
- international guidelines that are relevant to clinical trials, such as clinical safety data management
- ISO 14155:2020: This details the investigation of medical devices on human participants.
What is the difference between GCP and the National Standard Operating Procedures for Clinical Trials?
The National Standard Operating Procedures for Clinical Trials is a national government guide that protects the rights and safety of participants and ensures credible data. They include teletrials. These Operating Procedures are based on the ICH guideline for GCP (ICH E6 (R3).
Why GCP matters in trials
There are many reasons why good clinical practice matters, including:
Participant safety, well-being and rights
GCP focuses on putting practical measures in place that protect human participants involved in research. Not only does it work to protect their safety, well-being, and rights, but it also aims to minimise risks and avoid any unnecessary or avoidable harm.
Data integrity
GCP sets standards for the way data is collected, handled and reported on. The reason why this is important is that through rigorous data management practices, the information gathered from trials can be more accurate and credible. And with more credible clinical trial findings comes better decisions regarding the approval of new drugs and treatments.
Regulatory compliance
Good practice guidelines are in place for a reason – to protect participants and ensure data integrity – and therefore, they’re usually mandatory. Following GCP ensures regulatory compliance across all trials for better consistency.
Ensures international collaboration and consistency
Good clinical practice guidelines ensure the standardisation of ethical and scientific principles across countries. This harmonisation fosters international collaboration and advances medical progress across the globe.
Where to access GCP training in Queensland
If you are required to take good clinical practice training, ask your sponsor or relevant support provider for information about courses near you. Here are a few places where you can complete your certificate:
- A-CTEC Good Clinical Practice (GCP) = Good Clinical Practice
- WAHTN RET program Good Clinical Practice in Australia
- Genesis Services: Good Clinical Practice (ICH GCP) Training Course
- Your research organisation: Remember, you may not have to venture outside of your organisation to take a GCP training course. Your organisation will likely hold GCP training for all staff. In fact, many organisations make GCP training mandatory and require proof of training.
Have you done your refresher course after 3 years?
Did you know that after three years, you will need to take a refresher course? The WAHTN RET program listed above provides both the initial GCP qualification and the refresher course.
Frequently asked questions about good clinical practice
Good clinical practice (GCP) is the foundation of ethical and scientifically sound clinical research in Australia and across the globe. It prioritises the well-being of participants while ensuring the quality and reliability of research data. Here are the key pillars of GCP:
- Informed Consent: Voluntary participation is fundamental. Participants must thoroughly understand the risks and benefits of the trial before giving their consent. This requires a clear and comprehensive informed consent document that outlines all aspects of the research.
- Minimising Risks: Researchers have a responsibility to take all reasonable steps to minimise potential physical and psychological risks to participants. This involves careful study design, robust safety monitoring procedures, and immediate reporting of any adverse events.
- Data Integrity: Accurate and reliable data collection and record-keeping are crucial for trustworthy research outcomes. GCP emphasises meticulous documentation of all procedures, data collection processes, and any deviations from the protocol.
- Scientific Rigor: The research design, methodology, and data analysis must be scientifically sound. This ensures the validity of the research findings and their contribution to the advancement of medical knowledge.
- Independent Review: Ethics committees (known as Human Research Ethics Committees or HRECs in Australia) provide independent oversight of clinical trials. HRECs review research proposals to ensure they adhere to ethical principles outlined in the National Statement and GCP guidelines before approving the study.
- Qualified Personnel: Investigators and research staff must possess the necessary qualifications and experience to conduct the trial competently. This ensures the safe and ethical execution of the research protocol.
The responsibility for upholding GCP standards in Australia is shared by several key stakeholders:
- Investigators: They are ultimately accountable for ensuring the GCP-compliant conduct of the trial and the safety of participants. This includes developing a sound research plan, obtaining informed consent, maintaining proper documentation, and working collaboratively with the HREC and sponsor.
- Sponsors: The entity who takes overall responsibility for organising the trial (commercial company, government entity, university etc.) must ensure the research is conducted according to GCP guidelines. This involves selecting qualified investigators, providing adequate resources, and overseeing adherence to the research protocol.
- HRECs: These committees play a critical role in safeguarding research ethics. They review and approve research proposals, monitor ongoing trials, and address any concerns about ethical conduct or GCP compliance.
- TGA (Therapeutic Goods Administration): The TGA is Australia's regulatory body responsible for overseeing clinical trials and enforcing GCP compliance. The TGA provides guidance and resources for researchers, reviews applications for clinical trial authorisation, and conducts inspections to ensure adherence to GCP standards.
Here are some key steps to ensure your Australian clinical trial adheres to GCP:
- Reference the ICH E6 (R2) Guideline with TGA annotations: This guideline outlines the core GCP principles. The TGA annotations provide additional guidance specific to the Australian context.
- Obtain informed consent: Develop a clear and comprehensive informed consent document outlining the trial details, risks, and benefits.
- Maintain proper documentation: Meticulously document all procedures, data collection processes, and adverse events throughout the trial.
- Engage with a HREC: Submit your research proposal to a relevant HREC for review and approval before commencing the trial.
- Seek training: Consider GCP training programs offered by the TGA, universities, or professional organisations to deepen your understanding and ensure compliance.
Here are some valuable resources to help Australian researchers understand and implement GCP:
- The Therapeutic Goods Administration (TGA)
The TGA website offers a wealth of information on GCP guidelines, HRECs, and NSOPs. - National Health and Medical Research Council (NHMRC)
