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SQA Abstract – Impact of eSystems, etc.

Posted Oct 27 2009 11:01pm

I’ve submitted this abstract to the SQA for their annual meeting in April and am really hoping it is accepted. A very similar one that I posted last year was not….but this year, it seems that this sort of stuff is on their “hot topic” list. Fingers crossed.

~TJK

The Impact of Electronic Systems, eHRs, and eData on Clinical Research

Although the use of electronic data in the pharmaceutical industry is by no means a new phenomenon, its impact has evolved over time. Technology has revolutionized our lives in many ways; in the way we access information, in our entertainment, in the way we do business, and in the way we interact. This technological revolution has had very pronounced impacts on the GxP industries: eRecords, eData, eSignatures, Data Processing, Data Mining and the Regulatory Standards associated with them.

These impacts have been most apparent in the cGMP and GLP areas and there is a fair level of comfort with eData and Validation in those areas. Increasingly however, the impact of eData and the need for controls around its use can be seen in the GCP area. Due to its large reliance on external sources of data, Clinical Research has some unique challenges. This session will cover:

I. Technology in Pharma and Validation Overview: a discussion of these concepts (which are widely felt to be cGMP artifacts) and relating them to the GCP area through analogies.

II. Centralized GCP Technology: The use of centralized eData and eSystems, primarily on the “sponsor side” has some unique challenges due to very short timelines and the external nature of clinical data inputs. Also the challenges of study-specific validation activities will be addressed.

III. De-Centralized GCP Technology – “Technology at the Clinic”: The advent of electronic Health Records (eHRs) has had a profound impact on Clinical Research and the way in which source data is handled, however the adoption of eHRs has been uneven, piecemeal, and largely independent of any research concerns . Resultantly, source data at clinical sites varies widely in format, from purely paper systems through purely electronic integrated source systems. However, a large and growing number of sites use a hybrid paper/electronic model with various sources of data, scans of source destroyed by hospital systems, paper notes, dictated notes, email notifications, and central sponsor data collection systems. Some ideas on how to address various hybrid source data scenarios will be presented.

Level: Basic Validation, Intermediate Clinical
Key Words: GCP, Electronic Data, Hybrid Source, Validation

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