29
January

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The Food and Drug Administration (FDA) has announced the availability of a final guidance for industry titled "Electronic Source Data in Clinical Investigations." This final guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations. In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.

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1
June

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Since the first Babylonian recorded inventory on wet clay tablets in cuneiform text all those thousands of years ago, humans have gradually improved their data collection methods over the millennia - from clay to papyrus to vellum to paper, and now, at this juncture in history, as cleverly arranged electrons in a computer. What is common about all these technologies, including the computer enabled ones, is that a human agency is required to make the data useful.

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29
September

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In the course of various conferences, symposia and manuscript review for Applied Clinical Trials, one manages to keep abreast of current issues and concerns in the clinical research arena of the Life Sciences, as well as time-worn chronic points of contention are areas fraught with difficulty. In the latter bucket is usually found clarity of regulations, ownership of data & publication rights, issues with standards, and of course finding and retaining good investigators/sites, amongst other things.

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22
December

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First there was Electronic Data Capture, “EDC.” This was the initial step of storing data from clinical trials electronically, focused on patient CRF data. EDC rapidly became more than EDC, as integrated edit checks replaced the need for a separate data management cleaning step. Clinical Trial Management Systems (CTMS) focused more on the business aspects of a clinical trial, including site management, inventory control, and financial tracking. The separation of EDC from key CTMS functions missed the opportunity to integrate the patient information into the CTMS.

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