Validating electronic source data clinical trials


The original, or a certified copy of the source documents, including any query resolution documents, must be retained along with the data collected on case report forms.

When the original data are entered directly into the computerized system, the electronic record is the source document.

There are many issues to consider when conducting remote data capture or electronic trials (e-trials).

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 regulations are specific and require that certain processes and procedures be implemented to ensure the integrity of the data in each of these instances. The hardware and software used to create, modify, maintain, archive, retrieve, or transmit data must be documented, and this documentation must be retained in the specifi c study records.

As with all study-related files, the FDA can, and probably will, inspect the records and files intended to support a submission.



Additionally, the system must be tested and validated.Trials that use this technology have been dubbed “e-trials” or remote data capture (RDC) trials.


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