Learn all about good clinical practice: what it is, why it’s important, who needs to follow it, and which people are involved in implementing it.
Good Clinical Practice, also known as GCP, is an international set of standards designed to protect patients and ensure the integrity of clinical trials. These regulations are aimed at scientific studies that gather evidence to support the safety and effectiveness of certain investigational drugs for humans and animals, medical devices, and biological products.
GCP is applied and followed worldwide. While the Food and Drug Administration (FDA) regulates it in the US, there are various agencies and offices designated to regulate GCP in Europe, Australia, Malaysia, Singapore, and other territories. All of the standards are designed to protect the patients and ensure the clinical trials are conducted ethically while safeguarding the integrity of the results.
The two main reasons why GCP is important are that the standards protect the quality of the data and the safety of the patients. Without this, we may have to deal with numerous unsafe medical products, and patients undergoing clinical trials would have virtually no protections.
The most important role that GCP plays in clinical trials is making sure that the results are accurate and reliable. Without a definite set of standards, groups may conduct trials with their own framework, which can lead to skewed results that aren’t reliable. And if certain products hit the market without proper clinical trials, it could result in many undesirable circumstances like an ineffective or sometimes dangerous product.
Second, GCP protects individuals undergoing clinical trials. Aside from being a quality standard for clinical trials, it’s also an ethical standard. That way, all clinical trials for new medical products, investigative drugs, and biological products are conducted ethically, and the patient’s safety is never put at risk.
Humans have been testing medical products on humans as far back as 1900. But back then, there weren’t any regulations in place to protect patients and ensure reliable data. In fact, drugs back then were sold similarly to most commercial goods you may find on the shelf today. This means that there was always a fair chance that you buy an ineffective and even dangerous product off the shelf.
On top of that, the patients that underwent testing were also vulnerable to abuse or malpractice during clinical trials. This led to significant psychological and physical damage to certain patients in clinical trials. But with GCP, these patients were protected, and manufacturers could safely and ethically test their products before putting them on shelves.
There are many elements involved in GCP and it’s highly recommended that clinical investigators undergo proper GCP training before conducting trials. GCP has three primary goals which are quality data, protection of subject rights, and subject safety. Below, we go into the finer details of the goals of GCP.
For the clinical trial data to be reliable, all evidence and conclusions must be obtained in a scientific and logical manner. One of the main goals of GCP is to ensure clinical trials are conducted following a reliable framework that ensures clinical investigators get high-quality and reliable data.
One of the top priorities for clinical investigators should be the safety of the patients undergoing the trials. Both human and animal subjects in clinical trials must feel safe throughout the entire endeavor. If subjects don’t feel safe or their safety has been put at risk during the trials, then the investigators aren’t following GCP.
Subjects in a clinical trial are entitled to certain rights, and GCP ensures that all of these rights are protected. Some examples of subject rights that must be protected are the right to information, the right to withdraw their participation, and the right to confidentiality and privacy, along with many others.
Any group or individual conducting clinical trials on humans and animals must comply with GCP. Physicians and other qualified individuals that perform clinical trials are known as clinical investigators. And it’s imperative that all clinical investigators follow good clinical practice during their trials so that the data they gather from the experiments is reliable and accurate.
Groups or individuals that fail to comply with GCP when conducting clinical trials may risk getting reported to the FDA. These standards aren’t legally binding, but failure to comply with them may lead to others not accepting your findings, a breach of contract, or non-compliance findings, which may lead to further fines and consequences.
So, when conducting a clinical trial, it’s important to follow GCP as it will ensure that your data is reliable and the tests were conducted ethically.
GCP is not legally binding. This means that no particular law requires investigators to adhere to the standards. However, most governments use GCP as a framework for crafting their own regulations regarding good clinical practice and protecting the accuracy of data as well as the patient’s rights.
So, the people or agencies that implement and enforce GCP may vary depending on your location. However, it’s on everyone involved in the study and each investigator to ensure that the trials adhere to GCP so that the published data is as reliable and accurate as possible.
Adhering to GCP is very important when conducting clinical trials. That said, doing so can be quite a task, which is why Mitti (by SafetyCulture) may be a huge help to organizations and clinical investigators.
Some of the ways you can use Mitti (by SafetyCulture) when the following GCP include:
Use medical and clinical audit checklists to check if the trials are in line with GCP standards
Document every step of the process when conducting trials using annotated photo and video attachments
Gather data and analytics about nonconformities and other vital data on clinical trials that is very important when conducting the trials
Build custom workflows that follow the GCP standards
Train employees and investigators through Mitti (by SafetyCulture) Training
