Sunday, July 27, 2008

21 CFR Part 11 - Masking Real Data For Testing

Creating test data for clinical computing or software is always a challenge. I found this interesting and helpful article on the 21 CFR Part 11 blog, "Protecting test data privacy when testing protocol amendments," which describes how to mask real data. This is important for a couple reasons. First, it's all so important to guard protected health information (PHI). Therefore, it's critical to avoid the easy path of testing with real live, production information about people. Second, creating meaningful, usable, test data from scratch can be an arduous task. Protect the privacy of the health information, and happy testing.

Additional clinical data management resources that might interest you:

  1. Practical Guide to Clinical Data Management, Second Edition
  2. Clinical Data Management
  3. Management of Data in Clinical Trials (Wiley Series in Probability and Statistics)
Prior 21 CFR Part 11 Posts:
The Health, Drug, Prescription, and GMP Supersite: Resource List - FDA Part 11 - Electronic Records and Signatures

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