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Definition: "GCP," "GCPS," and "cGCPS" all stand (generally) for "Current Good Clinical Practice Standards," which are US government standards that must be met by laboratories generating clinical data for FDA.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
Several historical events in the 1900’s led to the creation and implementation of GCPs. For example, Nazi medical war crimes in the early 1900’s led to the creation of the Nuremberg Code, which asserts that voluntary participation for human subjects is essential, an idea central to the GCPs. Additionally, the Declaration of Helsinki was adopted by the World Medical Association in 1964. This is widely considered the first effort of the medical community to regulate itself. The first revision in 1975 introduced the concept of a review board, now called an Institutional Review Board (IRB) or Independent Ethics Committee (IEC). Another historical event that contributed to the creation of the GCPs was the Tuskegee Experiments, where men where exposed to syphilis and left untreated up until the 1970’s, despite treatment being available. This led to the creation of the Belmont Report, which is a document of ethical principles and the cornerstone on which U.S. federal regulations for the protection of human subjects are based. The GCPs have their origin in the Declaration of Helsinki and are undoubtedly influenced by these other ethical guidelines and documents that were developed in response to these historical events.
The GCPs provide guidelines for planning, running, and reporting studies that involve human subjects, as well as defining the roles of those involved in the process.
Institutional Review Board / Independent Ethics Committee (IRB/IEC)
An IRB/IEC should safeguard the rights, safety, and well-being of each study participant. The IRB/IEC reviews protocols, consent forms and other materials given to subjects, subject recruitment materials (e.g. advertisements) and the qualifications of the investigator to give approval or disapproval prior to study initiation. The IRB/IEC also re-reviews studies at intervals appropriate to the study to confirm that the study still meets its requirements, usually at intervals of one year. An IRB/IEC is made up of at least 5 members, with one member’s primary interest being in a non-scientific field, and one member being independent of the institution/trial site. For more information regarding Vivo Clinical Testing’s IRB, please click here.
The Investigator is the responsible leader of the testing team and may be called the Principal Investigator. The Investigator is qualified through education, training, and experience to assume responsibility for conducting the study, although they may delegate duties to other qualified individuals who are identified as sub-investigators. The Investigator must demonstrate that they have adequate resources to conduct the study, such as facilities, time, recruitment capabilities, and staff. It is also the Investigator’s responsibility to obtain informed consent from each participant prior to their participation in a study.
The Study Sponsor takes responsibility for the initiation, management, and financing of a clinical study. The Study Sponsor may transfer any or all of the Sponsor’s trial-related duties and functions to a Contract Research Organization (CRO), but the ultimate responsibility for the quality and integrity of the study always resides with the Sponsor. The Study Sponsor is responsible for implementing and maintaining quality assurance and quality control systems to ensure that studies are conducted and data are generated, documented, and reported in compliance with the protocol, SOPs, and GCPs. Study Sponsors are responsible for ensuring that a GCP study is adequately supervised. Sponsors or Sponsor-appointed qualified individuals, such as Monitors, ensure that the study is conducted and documented properly.
The study protocol outlines the parameters and procedures for conducting a study. The Sponsor and Investigator may coordinate to develop a protocol that suits their needs. The GCPs list fifteen elements that belong in every protocol, from general information to publication policy. Vivo Clinical Testing will work with you to develop a protocol that meets your needs and addresses the requirements of the GCPs.
The Investigator’s Brochure (IB) is a compilation of all data, both clinical and non-clinical, that is relevant to the test articles being evaluated, for any given study. The IB is meant to explain the rationale for many of the study’s key features introduced in the protocol (e.g. contact time). Generally, the Sponsor is responsible for maintaining the IB and making it available to the Investigator, and the Investigator provides the IB to the IRB/IEC.
Essential documents are maintained throughout the course of the study to permit study evaluation and reproducibility. These documents range from the Investigator’s curriculum vitae to IRB correspondence, and are always available for Sponsors, Monitors, the FDA, and any other applicable regulatory authorities to audit.