T. J. Kuhn | GxP Zone

Good Practice for the Pharmaceutical Industry from the Quality Assurance Perspective

New Draft EMEA Paper on Electronic Source Data

Posted by tjkuhn on January 9, 2008

Source data, the original entry for data in research or manufacturing, is expected to contain certain elements of Quality in the Pharma industry. These elements are often expressed with the acronym ALCOA (i.e., Attributable, Legible, Contemporaneous, Original, and Accurate).

When the data is in electronic format, the logistics of this change somewhat, and more guidance/clarification is typically needed. The Food and Drug Administration, FDA, has ruled on electronic data as source for clinical trials in the past.

Now the EMEA, the EU’s regulatory authority has published a draft paper outlining their expectations as to the use of electronic source in Clinical Trials. They have requested comments from industry stakeholders, experts, etc. by this April.

I have worked extensively in evaluating electronic data issues, especially in how they relate to clinical research, so I am very interested to see how  how EMEA’s position varies from FDA’s. I will be reviewing this paper thoroughly and time permitting, I may include a summary here.


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