{"id":5512,"date":"2022-12-20T10:20:55","date_gmt":"2022-12-20T10:20:55","guid":{"rendered":"https:\/\/www.qualifyze.com\/?p=5512"},"modified":"2026-03-30T14:48:06","modified_gmt":"2026-03-30T12:48:06","slug":"what-is-a-gcp-audit","status":"publish","type":"resources","link":"https:\/\/www.qualifyze.com\/resources\/what-is-a-gcp-audit\/","title":{"rendered":"What is a GCP Audit?"},"content":{"rendered":"\t\t
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In this article, we will be talking about GCP Audits, also known as Good Clinical Practice Audits. You will learn everything there is to know about what a GCP audit is, starting from the preparation steps when it comes to planning a GCP audit, to the execution of the audit and what to expect once your GCP audit has been completed. Furthermore, we will explain the basics of GCP (Good clinical practice), the Global guidelines for GCP, and various Good Clinical Practices (GCP) audit types and more.<\/p>\n

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What is GCP (Good Clinical Practice)?\u00a0<\/strong><\/h3>\n

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In order to understand all things related to\u00a0 a GCP audit, one must understand GCP (Good Clinical Practices). GCP refers to an international standard for designing, recording, and reporting trials involving human subjects’ participation. Complying with GCP provides you with the public assurance that human trial subjects\u2019 rights, safety, and well-being are protected and that the clinical-trial data are credible. The protection of human clinical trial subjects should be consistent with the Declaration of Helsinki principles. The Declaration of Helsinki explains the ethical principles of\u00a0 medical research involving human subjects, including research on identifiable human data and materials. The World Medical Association (WMA) has developed this statement. There are requirements for conducting clinical trials in the EU, including good manufacturing practice (GMP) and inspections in accordance with GCP or GMP.

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Global Guidelines for GCP<\/strong><\/h3>\n

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According to the principles of ICH E6 (R2)<\/a>: Guideline For Good Clinical Practice, there are 13 principles that set out the global guidelines for GCP, which are as follows:<\/p>\n

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  1. Ethical Principles\u00a0<\/li>\n<\/ol>\n

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    As part of clinical trials, ethical principles originated in the Declaration of Helsinki must be followed, as well as GCP and other applicable regulatory requirements.<\/p>\n

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    1. Trial risk vs. Trail benefit<\/li>\n<\/ol>\n

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      Before initiating a trial, a trial\u2019s foreseeable risks and inconveniences should be evaluated against the foreseen benefits for the individual trial subjects and society. A trial should be initiated and conducted only if the anticipated benefits justify the risks.<\/p>\n

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      1. Trail Subjects\u00a0<\/li>\n<\/ol>\n

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        The rights, safety, and well-being of the human trial subjects are the most vital considerations, should prevail over interests of science and society.<\/p>\n

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        1. Information on Medicinal Products<\/li>\n<\/ol>\n

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          The available clinical and nonclinical information on the investigational product should be satisfactory to support the proposed clinical trial.<\/p>\n

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          1. Good Quality Trails<\/li>\n<\/ol>\n

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            A clinical trial should be scientifically sound and documented in a clear, detailed protocol.<\/p>\n

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            1. Compliance with the protocol<\/li>\n<\/ol>\n

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              The trial should comply with the protocol that has received prior approval or favorable opinion from the IRB (institutional review board) or IEC (independent ethics committee).\u00a0<\/p>\n

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              1. Medical Decision<\/li>\n<\/ol>\n

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                The medical decision that is made on behalf of a subject must be the responsibility of the qualified physician or, a qualified dentist (when appropriate).\u00a0<\/p>\n

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                1. Trail Staff<\/li>\n<\/ol>\n

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                  In order to conduct a successful trial, each participant should be qualified by education, training, and experience for their respective tasks.<\/p>\n

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                  1. Informed Consent<\/li>\n<\/ol>\n

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                    Before participating in a clinical trial, free and informed consent should be obtained from each subject.\u00a0<\/p>\n

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                    1. Clinical Trail Data<\/li>\n<\/ol>\n

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                      The recording, handling, and storage of clinical trial data should ensure that it can be reported, interpreted, and verified accurately.<\/p>\n

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                      1. Confidentiality<\/li>\n<\/ol>\n

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                        The confidentiality of records that could identify trial subjects should be protected in accordance with the applicable regulatory requirements),\u00a0 respecting the privacy and confidentiality rules.<\/p>\n

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                        1. Good Manufacturing Practice (GMP)<\/li>\n<\/ol>\n

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                          The Investigational product should be manufactured, handled, and stored under applicable good manufacturing practices (GMP). And those products should be used as per the approved protocol.<\/p>\n

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                          1. Quality<\/li>\n<\/ol>\n

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                            Quality System with procedures assures the quality of each aspect of the clinical trial should be implemented.<\/p>\n

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                            Additionally, WHO has published a handbook of GCP Guidance for implementation, which is called \u201cHandbook for Good Clinical Research Practice (GCP)<\/a>.\u201d Similarly, this guideline consists of 14 Principles.

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                            Good Clinical Practices (GCP) \u2013 Audit types<\/strong><\/h3>\n

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                            The backbone of GCP compliance is the GCP audit. Principal investigators and site support personnel conduct GCP audits to assess compliance with regulatory requirements for clinical trial protocols and clinical quality management plans (CQMPs). GCP audits can have different purposes related to the clinical trial processes. Clinical trials can be audited for GCP compliance in many ways, including audits of sites monitoring, and operations conducted by monitors and trial management. This may be a full clinical trial audit of the trial sites, or an audit of the CRO conducting the trial on behalf of the sponsor. It is also possible to conduct a GCP audit to qualify and select a CRO. 

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                            Parts of a Comprehensive GCP Quality Audit<\/strong><\/h3>\n

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                            There are three main focuses to achieving a comprehensive GCP audit. <\/p>\n

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                            1. Audit of the investigator sites that are  participating in the clinical trial   <\/li>\n<\/ol>\n

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                              This will accomplish two things: <\/p>\n

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