Good Clinical Practice (GCP) in Clinical Trials—Explained

Several milestones built the foundation of what we now call Good Clinical Practice (GCP) in terms of clinical trials.

In the 1960s, scientists, medical professionals, and the general public were concerned about the ethical aspects and participant safety in clinical trials. The World Health Organization (WHO) have taken upon themselves to form scientific groups in the following decades. Their purpose was to evaluate the old and formulate new clinical trial principles.

In 1992, WHO outlined the Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products.

GCP Principles by WHO

There are 14 Good Clinical Practice principles put forth by WHO:

Ethical Conduct
Research Protocol
Risk Identification
Benefit-Risk Assessment
Review by Independent Ethics Committee/Independent Review Board
Protocol Compliance
Informed Consent
Continuing Review/Ongoing Benefit-Risk Assessment
Investigator Qualifications
Staff Qualifications
Records
Confidentiality/Privacy of Records
Good Manufacturing Practice
Quality Systems

ICH Guidelines for GCP Regarding Clinical Trials

With WHO’s principles as their basis, in 1997, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) made great strides in finalizing GCP. This was endorsed by the Food and Drug Administration (FDA). The reasons for drawing up Good Clinical Practices arose from the need for:

Safety
A more efficient research process
Drug research to be time-effective and less expensive
Expediting the drug-to-market process

The goal was to comprise unified standards for clinical trial practices.

What Are the ICH-GCP Principles?

According to ICH, there are 13 Good Clinical Practice Principles:

Ethical Conduct of Clinical Trials—participants’ safety and rights
Compared benefits and risks—benefits should justify the risks
Participants’ safety, well-being, and rights are more important than the interests of scientists
The available clinical and nonclinical information supports the clinical trial
Clinical trials must be scientifically sound and have a clear protocol
The Independent Ethics Committee (IEC)/Independent Review Board (IRB) should approve clinical trials before they start
Any medical care or decisions should be made by qualified medical professionals
Each individual involved in conducting a clinical trial should be qualified
Every clinical trial participant should freely decide to take part in it. They should give their informed consent before the trial begins
Accurate reporting, verification, and interpretation of all clinical trial information
Confidential records
Investigational products—drugs, treatment, and medical devices—should be manufactured in compliance with Good Manufacturing Practice (GMP)
Organized systems need to assure the quality of every aspect of a clinical trial

What Are the Goals of GCP Principles?

GCP should be a standard for the conducting, monitoring, and reporting of clinical trials. Working in accordance with GCP is vital to participants’ well-being.

The GCP goals are to:

Make sure the clinical trial data is reliable
Uphold the rights and safety of human subjects
Represent the standards of clinical research conduct

The FDA describes GCP as ethics combined with quality data, which is what the medical professionals should strive for.

Who Is Responsible for Making Sure GCP Principles Are Upheld?

Apart from medical professionals and other people involved in a clinical trial, various organizations and boards are responsible for ensuring GCP compliance in clinical trials.

Some of them are:

Contract Research Organizations (CROs)
Clinical Research Coordinators (CRCs)
Clinical Investigators (CIs)

Why Do I Need To Know About GCP?

As a participant, you should know that medical professionals are obligated to follow certain rules.

If you are worried about the risks and your rights during a clinical study, it helps to be familiar with GCP.

Once you know that many organizations ensure your safety and privacy, you can focus on finding the best clinical trial for yourself or your loved one.

DoNotPay—The Best Clinical Trial Finder

Participating in a clinical trial can be challenging enough, so the search for it should be as effortless as possible.

You type “clinical trials near me” in the Google search box, and you’re flooded with numerous results—blogs, shady websites, research centers, and pharmaceutical companies. How do you discern the reputable from the questionable ones?

You will have no issues with this if you use DoNotPay!

DoNotPay can speed up the whole clinical trial search process, find the best and the highest-paid clinical trials for you, and help you sign up. All you need to do is:

Access DoNotPay from your web browser
Select Clinical Trials
Tap on Get Started and customize the filters
Choose the trial you like best and hit Contact Now

Once you’ve done this, you can relax. We will email the research center and start the application process. Their staff should contact you soon after to confirm your eligibility and inform you about the next steps.

The Benefits of Using DoNotPay

Not only can we facilitate searching and applying for clinical studies, but we can also offer many other benefits.

DoNotPay’s AI-powered system requires no fees, and it allows you to:

Find paid clinical trials for healthy volunteers
Check the status of the clinical trials you signed up for
Browse a regularly updated clinical trial homepage
Pick and choose from an extensive database of clinical trials
Sign up for as many clinical studies as you want
Use the bookmarking feature to save and check clinical trials easily
Turn on text alerts to let you know when a new clinical study starts recruiting
Find university psychology studies and paid medical surveys
Search for clinical trials by age, location, compensation, and medical condition

Are you interested to know which cities offer clinical trials? Go on a deep dive and explore clinical studies in Miami, Boston, Orlando, St. Louis, and Los Angeles.

If you or your loved one is suffering from a specific illness, DoNotPay can provide you with a rundown on the current clinical trials for it. Some of them could be diabetes, fibromyalgia, Alzheimer’s, or dermatological conditions.

Can DoNotPay Help You With Anything Else in the Field of Medicine?

The U.S. healthcare system is complicated, to say the least. We’d be glad to help you in any way we can.

Are you interested in more clinical trials? DoNotPay can guide you through finding clinical studies in Utah, Ohio, Texas, Arizona, Florida, Indiana, or North Carolina.

Medical bills or insurance have got you down? DoNotPay may find a way! See if any of these apply to your situation:

Alternative Ways To Find and Join a Clinical Study

You can count on DoNotPay to fast-track the process of applying for a clinical trial. In case you want to give it a go by yourself, take a look at a few of the trustworthy websites where you can sign up for a clinical study:

Website	Key Features
ClinicalTrials.gov	Search by health condition Click on Advanced Search, and you can browse by your location, eligibility criteria, clinical trial phase, and study type Find more than 350 thousand clinical trials currently available on their website
Center Watch	Browse clinical trials based on your health condition, gender, location, and the clinical trial phase See clinical studies starting from the most recently added one
The National Institutes of Health (NIH) Clinical Center Studies Index	Comb through a database of publicly supported clinical trials Apply filters to your search, such as your age, gender, diagnosis, research center, and recruitment status of the clinical study

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