The importance of Good Clinical Practice guidelines and its role in clinical trials (2023)

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  • Biomed Imaging Interv J
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The importance of Good Clinical Practice guidelines and its role in clinical trials (1)

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Biomed Imaging Interv J. 2008 Jan-Mar; 4(1): e5.

Published online 2008 Jan 1. doi:10.2349/biij.4.1.e5

PMCID: PMC3097692

PMID: 21614316

A Vijayananthan, MBBS, MRad*,1 and O Nawawi, MBBS, MRad, FRCR

Author information Article notes Copyright and License information Disclaimer

(Video) Good Clinical Practice and ICH GCP Guidelines


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. It also serves to protect the rights, integrity and confidentiality of trial subjects. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in itself, explains the reasons and the need for doing so. In this paper, we address the historical background and the events that led up to the formation of these guidelines. Today, the ICH-GCP guidelines are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights.

Keywords: Clinical practice, international, ethical, historical


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. GCP provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are respected and protected [1]. It was finalised in 1996 and became effective in 1997, but was not enforced by law at that time. The Medicines for Human Use (Clinical Trials) Regulations 2004 and the European Union (EU) Directive on Good Clinical Practice changed the world perspective , and compliance with GCP is now a legal obligation in the UK/Europe for all trials involving the investigation of medicinal products [2].


It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in itself, explains the reasons and the need for doing so ((Table 1)). The concept of the ‘good physician‘ dates back to the ancient world and it is evidenced by the Hippocratic Oath (460 BC). In the United States, the first landmark in the regulation of drugs was the Food and Drugs Act of 1906. This was a result of harmful and lethal drugs that could be bought across the counter just like any other consumer product. Some examples are ‘Grandma’s Secret’ and ‘Kopp’s Baby’s Friend’ which contained large doses of morphine, as well as ‘Dr King’s Consumption Cure‘ and ‘Dr Bull’s Cough Syrup‘ which contained morphine and chloroform [3]. In 1938, the Federal Food, Drug and Cosmetic Act was enacted by the Food and Drug Administration (FDA) and for the first time, manufacturers were required to test drugs for safety and present the evidence of safety testing to the FDA prior to marketing [3].

Table 1

Historical background of GCP

460BCOath of Hippocrates
1930'sU.S. Food, Drugs and Cosmetic Act
1947Nuremberg Code
Dec. 10th 1948Declaration of Human Rights
1962Kefauver-Harris Amendment
1964, revised 2000Declaration of Helsinki
1979The Belmont Report
1982International Guidelines for Biomedical Research Involving Human Subjects
1996ICH-GCP guidelines issued
1997ICH-GCP guidelines becomes law in some countries

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In 1947, the Nuremberg Code was created as a result of the unethical and horrific experiments carried out during World War II at Nazi war camps by German physicians, who were subsequently tried and charged at the Nuremberg Military Tribunal. This code states the need for a scientific basis in research on human subjects and voluntary consent and protection of participants [4,5]. The Universal Declaration of Human Rights (December 10th 1948) was also adopted and proclaimed by the United Nations after the atrocities of World War II and it further reiterated the human factor involved in medical experiments.

In 1964, the Declaration of Helsinki was developed by the World Medical Association, forming the basis for the ethical principles that underlie the ICH-GCP guidelines we have today. The focus of this declaration is the protection of the rights of human subjects and this is clear in its introduction [6]:

“The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. It is the duty of the physician to promote and safeguard the health of the people. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty”

In 1962 the world was once again shocked by the severe foetal limb deformities linked to the use of maternal thalidomide. In fact this drug reaction was only discovered after 10,000 infants were born in over 20 countries worldwide. In response to this, the Kefauver-Harris Amendments were passed which required the FDA to evaluate all new drugs for safety and efficacy [3].

Another important milestone in the formation of the ICH-GCP guidelines was The Belmont Report which was issued in April 1979 by the National Commission for Protection of Human Subjects of Biomedical and Behavioural Research [7]. The principles of this report are as follows:

(Video) Introduction to Good Clinical Practice (GCP) Guidelines E6R2

  1. Respect for Persons: This principle acknowledges the dignity and freedom of every person. It requires obtaining informed consent from research subjects (or their legally authorised representatives)

  2. Beneficence: This principle requires that researchers maximise benefits and minimise harms associated with research. Research-related risks must be reasonable in light of the expected benefits.

  3. Justice: This principle requires equitable selection and recruitment and fair treatment of research subjects.

In 1982, the World Health Organization (WHO) and the Council for International Organizations of Medical Sciences (CIOMS) issued a document entitled ‘International Guidelines for Biomedical Research Involving Human Subjects‘. This document was released to help developing countries apply the principles of the Declaration of Helsinki and the Nuremberg Code [3]. Worldwide, many organisations and committees issued various documents and guidelines on the same issue, and a decision was taken to consolidate all these guidelines into one universal guideline to be used globally.

In an effort to overcome international GCP inconsistencies throughout the countries, the International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) issued the ICH Guidelines: Topic E6 Guideline for GCP. This guideline was approved on 17 July 1996 and implemented for clinical trials from 17 January 1997. The participants of these guidelines were representatives of authorities and pharmaceutical companies from the EU, Japan and the United States as well as those of Australia, Canada, the Nordic countries and WHO [8].


The ICH-GCP is a harmonised standard that protects the rights, safety and welfare of human subjects, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected and consistent with the principles of the Declaration of Helsinki, and that the clinical trial data is credible [8]. A historical background of the reasons and the importance of GCP is summarised in (Table 2).

Table 2

Reasons for GCP

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

  1. 1. Clinical trials should be conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).

  2. 2. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.

  3. 3. The rights, safety and well-being of the trial subjects are the most important considerations and should prevail over interest of science and society.

  4. 4. The available non-clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.

  5. 5. Clinical trials should be scientifically sound, and described in clear, detailed protocol.

  6. 6. A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/ independent ethics committee (IEC) approval/favourable opinion.

    (Video) Good Clinical Practices (GCP) and 13 Principles of ICH-GCP

  7. 7. 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.

  8. 8. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).

  9. 9. Freely given informed consent should be obtained from every subject prior to clinical trial participation.

  10. 10. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.

  11. 11. 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).

  12. 12. 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.

  13. 13. Systems with procedures that assure the quality of every aspect of the trial should be implemented.

These principles are self-explanatory and, when summarised, simply mean:

All clinical trials should be conducted in accordance with ethical principles, sound scientific evidence and clear detailed protocols. The benefits of conducting trials should outweigh the risks. The rights, safety and well-being of trial participants are of paramount importance and these should be preserved by obtaining informed consent and maintaining confidentiality. The care must be given by appropriately qualified personnel with adequate experience. Records should be easily accessible and retrievable for accurate reporting, verification and interpretation. Investigational products should be manufactured according to Good Manufacturing Practice (8).

It is also important to mention the participants of GCP in clinical trials and their respective responsibilities. These are summarised in (Table 3).

Table 3

GCP participants

Regulatory AuthoritiesReview submitted clinical data and conduct inspections
The sponsorCompany or institution/organization which takes responsibility for initiation, management and financing of clinical trial
The project monitorUsually appointed by sponsor
The investigatorResponsible for conduct of clinical trial at the trial site. Team leader.
The pharmacist at trial locationResponsible for maintenance, storage and dispensing of investigational products eg. Drugs in clinical trials
PatientsHuman subjects
Ethical review board or Committee for protection of subjectsAppointed by Institution or if not available then the Authoritative Health Body in that Country will be responsible
Committee to monitor large trialsOverseas Sponsors eg. Drug Companies


Since the conception of the ICH-GCP guidelines, many countries in the Asia-Pacific region realised the need to formulate guidelines of their own based on the framework of the original guidelines [7]. This is clearly seen in (Table 4) that tabulates the adoption of GCP in our country and its neighbours.

Table 4

Table 4 GCP Adoption in the Asia Pacific Region

(Video) Good Clinical Practice (GCP) , lecture # 1-Introduction & Principles of GCP #eventtroop

Original ICH-GCP Guidelines1996
Singapore GCP 1998
Chinese GCP1999
Malaysian GCP1999, revised 2004

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In Malaysia, similar guidelines were formulated in the wake of greater demand by the pharmaceutical industry to conduct clinical trials in the country. The Malaysian Guidelines for GCP was first published in October 1999 and the second edition was released in January 2004. The guideline adopts the basic principle outlined by the International Committee on Harmonization of Good Clinical Practice (ICH-GCP) with some modifications to suit local requirements [1,7].


The importance of GCP lies in the question ‘why’ and ‘how’ GCP trials came about. To know the answer to this, we have to look to the historical background that led to the formulation of GCP guidelines in the United States and Europe and also to the formation of the ICH. The events that led up to the culmination of the ICH-GCP guidelines brought forth public awareness that there was a need to control and regulate clinical trials dealing with drugs and human subjects. The violation of human rights played a large role and that is why the Declaration of Helsinki and The Nuremberg Code remain as the framework of the present guidelines. The ICH-GCP guidelines are therefore considered the ‘bible’ of clinical trials, and have become a global law which safeguards humanity as we know it today.


1. Malaysian Guidelines for Good Clinical Practice. 2nd edition. Ministry of Health Malaysia; 2004. [Google Scholar]

2. Imperial College Clinical Research Governance Office. Good Clinical Practice [Web Page] 2007. Available at

3. Otte A, et al. Good Clinical Practice: Historical background and key aspects. 2005;26:563–74. [PubMed] [Google Scholar]

4. Office of Human Subjects Research. The Nuremberg Code [Web Page] 1949. Available at

5. The Doctors Trial (the Medical Case of the Subsequent Nuremberg Proceedings) [Web Page] Available at

6. The World Medical Association. Declaration of Helsinki [Web Page] 2004. Available at

7. Vadivale M. ICH-GCP Guidelines for Clinical Trials. Berita MMA. 1999;7(29) [Google Scholar]

(Video) History of Clinical Trials - A Road to Good Clinical Practice (GCP) Guideline

8. European Medicines Agency. ICH Harmonised Tripartite Guideline E6: Note for Guidance on Good Clinical Practice (PMP/ICH/135/95) London: European Medicines Agency; 2002. [Google Scholar]

Articles from Biomedical Imaging and Intervention Journal are provided here courtesy of Department of Biomedical Imaging, University of Malaya; and the University of Malaya Research Imaging Centre (UMRIC)


The importance of Good Clinical Practice guidelines and its role in clinical trials? ›

GCP helps protect participants by ensuring a high level of quality for each trial that is conducted. The standards also ensure accurate reporting of study results and protect against fraudulent or misleading data so that consumers can trust the products they use.

Why are good clinical practice guidelines important? ›

GCP helps protect participants by ensuring a high level of quality for each trial that is conducted. The standards also ensure accurate reporting of study results and protect against fraudulent or misleading data so that consumers can trust the products they use.

What is the purpose of GCP in clinical trials? ›

GCP is an international standard for clinical trials that ensures that the rights, safety, and well-being of clinical trial subjects are protected and that the clinical trial data are credible. Various legislative requirements exist for GCP training from a country level to global.

How are GCP guidelines helpful in maintaining the integrity of a clinical trial? ›

GCP assures that the data and reported results are reliable and accurate and that the rights, integrity and confidentiality of study subjects are respected and protected. GCP aims to ensure the following: Subject safety: The human subject must feel safe at all times during the trial.

What is good clinical practice in clinical trials? ›

Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects.

Why are GCP guidelines important? ›

Compliance with good clinical practice guidelines provides assurances that the studies are scientifically and ethically sound. In addition, GCP ensures that trial subjects' rights, integrity, and confidentiality are protected and that the clinical trial data are credible and accurate.

What impact does GCP implementation have on clinical trials? ›

Definition of Good Clinical Practice (GCP)

Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible and accurate.

What is benefit of GCP? ›

Better collaboration

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What are the 3 main GCP principles? ›

Three principles of equal importance associated with basic ethics, particularly recognized for persons, beneficence, and justice, permeate all other GCP principles.

What are the advantages of GCP? ›

Quick collaboration: GCP allows quick collaboration for multiple users as they can be working from different countries and can yet access and edit a project at the same time. Pricing: GCP offers a monthly pricing plan which is billed according to the monthly usage. It also provides committed use discounts.

What are clinical practice guidelines and how do they impact quality? ›

Clinical practice guidelines are statements that include recommendations intended to optimize patient care. They are informed by a systematic review of evidence, and an assessment of the benefits and harms of alternative care options.

What is the most important consideration of the principles of GCP? ›

GCP core principles

The rights, safety and wellbeing of the trial subjects are the most important considerations and should prevail over interests of science and society.

What is the most important ethical feature of clinical trials? ›

A major ethical concern related to clinical trials is whether participants are fully informed about the risks entailed in the trials and the likelihood that they will not personally benefit from the research.

What are the key principles of good clinical practice? ›

Key Principles of Good Clinical Practice (GCP)
  • Adherence to ethical principles.
  • Risk minimization.
  • Subject's rights, safety, and well-being.
  • Adequate drug information.
  • Scientifically sound protocols.
  • IRB/IEC review and approval and protocol adherence.
  • Involvement of qualified physician.

What best describes a clinical practice guideline? ›

The Institute of Medicine (IOM) defines clinical practice guidelines as "statements that include recommendations, intended to optimize patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options" [1].

What are the 4 pillars of ICH GCP? ›

Informed Consent & Patient Safety
  • Informed Consent.
  • Safety of Human Subjects in Clinical Research.

How do clinical practice guidelines affect the clinical decision making process? ›

Guidelines assist the clinicians in the decision making process, help them in taking difficult decisions in complicated cases and allows them to follow a particular treatment course (vs another available one) for the best desired outcome. Guidelines help clinicians defend themselves in the Court of Law.

Why was GCP introduced? ›

The development of GCP began at the end of WW2 following the Nuremberg Trials. During these trials Nazi Doctor's were prosecuted for performing inhumane experiments on human beings in the name of medical science.

What are the 7 benefits of GCP? ›

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What is the role of GCP? ›

GCP IAM roles explained

Predefined: Predefined roles provide finer-grain access to specific services in the Google Cloud. Custom: Custom roles provide finer-grain access to an organization-specific list of permissions to meet specific needs.

What is the responsibility of GCP? ›

GCP customers are responsible for ensuring that firewalls that meet Section 1 requirements are implemented on inbound and outbound traffic, to and from any customer instances deployed on GCP meet the requirements of Section 1 of the PCI DSS.

What is the golden rule in GCP? ›

Golden Rule 1: All Infrastructure Must Be Created Fully Automatically by the Infrastructure Code. It is so common how often this rule is violated and practically always violating this rule ends up with a fragile infrastructure.

What is the core element of GCP? ›

GCP is focused on the protection of the rights, integrity, and confidentiality of clinical trial participants and the accuracy and scientific integrity of the data collected during clinical trials and reported in the results.

What is unique about GCP? ›

1) Live Migration of Virtual Machines: Google Compute Engine live migrates the running instances to another host in the same zone instead of requiring the VMs to be rebooted in case of any maintenance activities like patching, hardware upgrade etc.

When should you use GCP? ›

You use a cloud platform such as GCP when you want to build and run an application that can leverage the power of hyperscale data centers in some way: to reach users worldwide, or to borrow sophisticated analytics and AI functions, or to utilize massive data storage, or to take advantage of cost efficiencies.

What is fact about GCP? ›

GCP provides infrastructure as a service (IaaS), platform as a service (PaaS), and software as a service (SaaS) to organizations worldwide. Importantly, GCP is a service mainly for building and maintaining original applications that can subsequently be published from its hyperscale data centers.

How are clinical practice guidelines implemented? ›

Clinical practice guidelines (CPGs) are developed through a rigorous systematic methodology synthesizing the ever-increasing amounts of published literature into a practical and digestible set of clinical recommendations to be used in a healthcare setting.

What is the difference between clinical guidelines and protocols? ›

A guideline is defined as a principle or criterion guiding or directing action (Concise Oxford Dictionary, 1996), a protocol is defined as a rule relating to a procedure (Concise Oxford Dictionary, 1996).

What are the introduction to clinical practice guidelines? ›

Clinical practice guidelines (CPGs) are systematically developed statements aimed to optimize patient care and experience; they are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options [1, 2].

What does GCP mean in research? ›

Good Clinical Practice covers the way a clinical trial is designed, conducted, performed, monitored, audited, recorded, analyzed, and reported. Also called GCP.

What are two reasons why ethical principles in research are important? ›

Research ethics govern the standards of conduct for scientific researchers. It is important to adhere to ethical principles in order to protect the dignity, rights and welfare of research participants.

Why are there ethical principles that act as guidelines for clinical research? ›

The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science.

What are the four basic ethical principles in clinical trials? ›

The four fundamental principles of ethics which are being underscored are autonomy, non-maleficence, beneficence, and justice.

What is the purpose of a guideline? ›

What is a guideline? Guidelines guide employees through a process or a task. They give general recommendations of how to perform a task, or advice on how to proceed in a situation. They usually provide a good overview of how to act in a situation where there's no specific policy or standard.

What is a good practice guideline? ›

The Good Practice Guidelines draw on the knowledge of practitioners from all over the world as well as information within International Standards. As a result, the GPG is globally recognised as the go-to publication for good practice.

What is the difference between a practice standard and a practice guideline? ›

Practice standards are authoritative, whereas practice guidelines are recommendations. Consensus statements and position papers serve mainly as information sources; their recommendations aren't binding.

Why are professional guidelines important? ›

Professional standards guarantee that we're accountable for our clinical decisions and actions, and for maintaining competence during our career. They're patient centered, promote the best possible outcome, and minimize exposure to risk of harm.

What are good clinical guidelines? ›

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve people.

What is the purpose of clinical practice guidelines to provide a plan to manage? ›

The purpose of clinical practice guidelines is to provide a plan to manage a clinical problem based on evidence or consensus, to lower costs, and to improve health outcomes.

What are the three principles of good clinical practice? ›

Three basic ethical principles of equal importance, namely respect for persons, beneficence, and justice, permeate all other GCP principles.

What are the main ethical principles of clinical trials? ›

Core Principles

Verifying the scientific validity of the results. Choosing clinical trial participants in a way that is fair and free of prejudice. Fully informing all volunteers about what the trial involves and potential risks before they offer their consent.

Why is it important for a professional to have ethical guidelines? ›

It provides a common set of rules or standards for all in the profession to adhere to. It defines best practices for the profession. It provides a basis to meet compliance requirements for the profession. It provides a legal standard for the profession.

How are clinical practice guidelines developed? ›

CPGs are developed through a systematic review of the evidence, an assessment of the potential benefits and harms of the recommendations, and, if appropriate, a cost-benefit analysis of the recommendations.

What are standards of care in clinical trials? ›

The control group is sometimes given a placebo or they are given the best treatment option that is available and is the market leader for the drug that is being tested. This is known as the standard of care; the treatment of the disease that most physicians agree is the best.


1. GCP Part 1 - Principles of Good Clinical Practice - Explained
(Clinical Research Handbook)
2. GCP webinar
3. (GCP) Good Clinical Practice - PMDA-ATC E-learning
(Pmda Channel)
(Pharma_Tutor Swapnil Mishra)
5. Good Clinical Practices Guideline | ICH-GCP | Principles of GCP | Hindi | Pharmacovigilance Notes
(Tutor Box)
6. The Imperative Role Of Good Clinical Practice Guidelines (ICH- GCP) In Clinical Trials
(British BioMedicine Institute)
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