SOCRA CCRP Practice Exam

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How does the FDA define source data or documents?

As digital databases
As medical records and case histories
As physical samples
As laboratory reports

The correct answer is: As medical records and case histories

Source data or documents are defined by the FDA as medical records and case histories. This is because these types of data and documents provide accurate and comprehensive information about a patient's medical history, including diagnoses, treatments, and medications. Option A, digital databases, may contain some of this information but they are not always comprehensive and may not include all relevant data. Option C, physical samples, may be used for testing but do not provide the necessary documentation of a patient's medical history. Option D, laboratory reports, may be a part of a patient's medical records, but they do not include the full scope of information needed to understand a patient's medical history. Therefore, option B is the most accurate and comprehensive definition of source data or documents according to the FDA.