The need to protect human subjects who participate in clinical research is universally recognized and reflected in the wide use of what is known as Good Clinical Practice (GCP) guidelines. Many countries have adopted GCP guidelines and regulations, which consist of internationally accepted standards for the design, conduct, monitoring, and reporting of clinical trials, such as the ICH GCP E6 R2 Addendum, which encourages implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results.
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In the United States, the Food and Drug Administration (FDA) enforces a number of GCP guidelines and regulations pertaining to clinical trials. In addition, the agency has adopted the International Conference on Harmonization (ICH) E6 GCP Consolidated Guidance. These GCP guidelines and regulations apply to all clinical trials that fall under the FDA’s jurisdiction.
A good example of how GCP guidelines and regulations protect patients is the concept of “informed consent.” Under the FDA’s 21 CFR Part 50, informed consent helps ensure that subjects participate in a clinical trial voluntarily. The clinical investigator conducting the clinical trial is responsible for making sure that each participant is properly informed about the goals and corresponding risks of the study. The FDA requires subjects (or the subject’s authorized representative) to sign informed consent forms as proof that the patients’ rights are being protected.
The MasterControl Clinical Quality Management System (CQMS) is a complete clinical quality solution designed to help ensure compliance with GCP guidelines and regulations. The solution provides a single, web-based system for all critical documents. MasterControl’s CQMS streamlines processes by managing all documents, studies, tasks, processes, training, quality events and audits throughout the life of a clinical trial. Here are some of benefits it provides:
The MasterControl Reference Model-TMF JumpStart, based on the Drug Information Association’s (DIA) Trial Master File (TMF) Reference Model, can store and track thousands of clinical study artifacts according to document type, metadata, and taxonomy, based on the DIA TMF Reference Model. It streamlines collaboration activities and automates the routing, review, and approval of documents.
MasterControl’s CQMS was designed according to GCP guidelines and regulations. It manages information pertaining to study site selection criteria (location, specialty, facility type, study phase capability) and site capabilities (facilities and equipment), as well as investigator documentation and IRB documentation. It streamlines the secure exchange of documents among investigators, trial site support staff, sponsors, CROs, and CMOs.
MasterControl helps ensure compliance with GCP guidelines and regulations by connecting all critical clinical trial processes such as deviation, corrective and preventive actions (CAPA), training control, and audit management. It offers flexibility in creating forms and checklists for managing processes in accordance with Good Clinical Practice guidelines.
Medical device companies that sell their products in the United States must comply with the FDA’s GCP guidelines and regulations. In addition, most of them also comply with ISO 14155: 2011 (Clinical Investigations of Medical Devices for Human Subjects: Good Clinical Practices) and the GCP ICH (E6) Efficacy guidelines.
The GCP guidelines under ISO 14155: 2011 apply to the design, conduct, recording and reporting of clinical investigations conducted to assess the safety or performance of medical devices. It covers the responsibilities of sponsors and clinical investigators and makes recommendations on investigational plans, final reports, and assessments of adverse events.
For more information about GCP guidelines and how MasterControl can help your organization achieve and sustain GCP compliance, please feel free to contact a MasterControl representative.