One of my friends asked me what would be the source data and how to verify if the data was directly entered into EDC. A recent article in clinicaltrialsonline.com answered this question. it looks like this is the topic covered under FDA's new guidance "Computerized Systems Used in Clinical Invesitgations" http://www.fda.gov/cder/guidance/7359fnl.htm.
Scenario 1: Data are first captured on paper and then manually entered into a computerized system. Source data are the paper documents. Examples: Data collected at clinical sites, IRBs, and medical practices.
Scenario 2: Data are first captured electronically into a computerized system and then manually entered into another database. Source data are the electronic records in the computerized system. Examples: Data collected at clinical sites, diagnosis after test evaluation in medical institutions.
Scenario: 3: Data are first captured electronically into a computerized system. Source data are the electronic records in the computerized system. Examples: Data collected at clinical sites, clinical laboratories, analytical laboratories, etc.
To read the full article, please visit "http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=546112&sk=&date=&pageID=3"
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