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ROI CalculatorGood Clinical Practice or GCP is an international quality standard that governments can transpose into regulations that decide how clinical trials involving human subjects must be managed.
The purpose of the GCP guidelines is to promote ethical and scientific conduct of studies, and to protect the human rights of research subjects and volunteers. All documentation related to the studies is carefully controlled and reviewed. Documentation can include a clinical study protocol, a document that provides all the details associated with the study and also details of how investigators intend to protect research subjects and obtain high quality data from research subjects participating in the study by describing the objectives of the study, the design of the study, methods of collecting data, and analytical/statistical issues related to the analysis of data.
Clinical studies must follow GCP, which provides standards for protecting the rights of study participants and obtaining valid and reliable data from the study. GCP has many aspects to it, such as ethical standards to follow, the responsibilities of an investigator, and methods to protect the confidentiality of patient data.
Documents must be created for general records about the clinical study, staff training records, and qualification of both the site and facilities where the clinical trial is performed and how much quality assurance, monitoring, and auditing is performed.
The ICH or International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use is sometimes referenced when discussing GCP. The mission of the ICH is to improve public health by promoting global harmonization in the development of drugs internationally. The ICH aims to achieve this by developing technical requirements and guidelines that are applicable to regulatory authorities and pharmaceutical industries worldwide. The goal of harmonization is to create rational use of human and animal resources while reducing the time needed to develop new treatments.
Clinical Research has been performed for hundreds of years. However, until recently, no global standards had been established. This is mainly due to the complexity of clinical research containing multiple industries (like devices or drugs), having numerous subject types (human, animal), and many different approaches, techniques, tools and sources of data used in conducting clinical research.
In the last few years, clinical research has increased substantially in volume. Approximately ten years ago, there were approximately 137,000 registered clinical trials around the globe. By March of 2022, there were 409,300 clinical trials registered globally, nearly 200% growth in ten years. This does not take into account the effects of COVID-19 on the system.
All these reasons justify the importance of establishing a global standard of operations so that as clinical trials grow rapidly, they have an established guideline to work on that forms the basis for creating high-quality processes associated with clinical research.
