An example is pressing the key of a keyboard that causes information to be saved to durable medium.Ĭomputerized System means, for the purpose of this guidance, computer hardware, software, and associated documents (e.g., user manual) that create, modify, maintain, archive, retrieve, or transmit in digital form information related to the conduct of a clinical trial.ĭirect Entry means recording data where an electronic record is the original capture of the data. The principles in this guidance may be applied where source documents are created (1) in hardcopy and later entered into a computerized system, (2) by direct entry by a human into a computerized system, and (3) automatically by a computerized system.Īudit Trail means, for the purposes of this guidance, a secure, computer generated, time-stamped electronic record that allows reconstruction of the course of events relating to the creation, modification, and deletion of an electronic record.Ĭertified Copy means a copy of original information that has been verified, as indicated by dated signature, as an exact copy having all of the same attributes and information as the original.Ĭommit means a saving action, which creates or modifies, or an action which deletes, an electronic record or portion of an electronic record. It also addresses requirements of the Electronic Records/Electronic Signatures rule (21 CFR part 11). This guidance document reflects long-standing regulations covering clinical trial records. This guidance does not address electronic submissions or methods of their transmission to the Agency. Persons using the data from computerized systems should have confidence that the data are no less reliable than data in paper form.Ĭomputerized medical devices, diagnostic laboratory instruments and instruments in analytical laboratories that are used in clinical trials are not the focus of this guidance. Although the primary focus of this guidance is on computerized systems used at clinical sites to collect data, the principles set forth may also be appropriate for computerized systems at contract research organizations, data management centers, and sponsors. This guidance addresses how these elements of data quality might be satisfied where computerized systems are being used to create, modify, maintain, archive, retrieve, or transmit clinical data. In an automated system, attributability could be achieved by a computer system designed to identify individuals responsible for any input. For example, attributable data can be traced to individuals responsible for observing and recording the data. Data should be attributable, original, accurate, contemporaneous, and legible. To be acceptable the data should meet certain fundamental elements of quality whether collected or recorded electronically or on paper. FDA's acceptance of data from clinical trials for decision-making purposes is dependent upon its ability to verify the quality and integrity of such data during its onsite inspections and audits. As such, these data have broad public health significance and must be of the highest quality and integrity.įDA established the Bioresearch Monitoring (BIMO) Program of inspections and audits to monitor the conduct and reporting of clinical trials to ensure that data from these trials meet the highest standards of quality and integrity and conform to FDA's regulations. These data form the basis for the Agency's decisions regarding the safety and efficacy of new human and animal drugs, biologics, medical devices, and certain food and color additives. This document addresses issues pertaining to computerized systems used to create, modify, maintain, archive, retrieve, or transmit clinical data intended for submission to the Food and Drug Administration (FDA). CERTIFICATION OF ELECTRONIC SIGNATURES *ĬOMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS Backup and Recovery of Electronic Records * Facilitating the inspection and review of data *Ĭ. Facilitating the collection of quality data *ī. Department of Health and Human ServicesĬenter for Biologic Evaluation and Research (CBER)Ĭenter for Drug Evaluation and Research (CDER)Ĭenter for Devices and Radiological Health (CDRH)Ĭenter for Food Safety and Nutrition (CFSAN)Ī.
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