Validating electronic source data in clinical trials

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Critical components are those that have impact on the integrity of the study.So components related to data and systems that an IRB may use to make their determinations when there are critical outcomes that will result from using these systems.This article outlines the components of the Food and Drug Administration’s regulations concerning the use of electronic records and electronic signatures (ERES), highlights the regulations that affect investigator sites, describes the roles and process changes necessary to conduct an e-trial, identifi es sponsor/contract research organization considerations affecting ERES compliance, and discusses the impact of an e-trail when conducting quality assurance audits.The use of computerized data he use of computerized data in clinical trials has generally been limited to a centralized database with independent data entry from the paper case report form (CRF) into the database and subsequent analysis of the data.The guideline includes the requirements for records, how these are to be kept and the conditions under which they are to be made available for monitoring, auditing and inspection.This guideline document applies to all records created during the conduct of clinical trials and includes the records of Sponsors, Qualified Investigators, Research Ethics Boards which approved clinical trials, as well as those other stakeholders involved in the conduct of clinical trials that are the subject of the When an independent investigator initiates a clinical trial under his/her own sponsorship, he or she becomes responsible for all aspects of that trial, both as a Qualified Investigator and a Sponsor. Inquiries about this document can be addressed in writing to the GCP Coordinator, Good Clinical Practices Compliance Unit, by telephone at (613) 952-8173, by fax (613) 952-9805, or by e-mail at: [email protected]

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The modalities of e Source models that allow for direct data capture from other electronic data sources include, but are not limited to: Many of the above modalities have existed in health care for some time, but the clinical trial landscape is evolving to include more of this data, as we move away from paper records, and the subsequent transcription and associated Quality Control mechanisms.e Source adoption presents meaningful improvements to Data Integrity in clinical trials.A sponsor’s present processes (especially if EDC is already in use) for protocol development, site management and study conduct may not prohibit the use of modern technology (such as e Source) in Clinical Trials.366 individuals from the clinical research industry attended: 31% from an Academic Medical Center, 23% from a Hospital or Health System, 12% from a Dedicated Research Site, 11% from a Cancer Center, 7% from a Physician Practice, and 5% from a Sponsor or CRO.Along with the technology comes an array of issues that require attention and may alter the traditional processes used in conducting clinical trials within Good Clinical Practices (GCPs).The Food and Drug Administration (FDA) worked with industry to develop regulations (21 CFR Part 11) that address uniform standards to ensure that electronic records and signatures are as accurate, secure, and reliable as paper records and handwritten signatures.

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