Suggested Answer:A🗳️
As per FDA data should be attributable, original, accurate, contemporaneous and legible. In an automated system attributability could be achieved by a computer system designed to identify individuals responsible for any input. Source: U.S. Department of Health and Human Services, Food and Drug Administration, Guidance for Industry - Computerized Systems Used in Clinical Trials, April 1999, page 1.
Attributable data, in the context of data integrity and accountability, should be:
A. always traced to individuals responsible for observing and recording the data
Attributable data means that each piece of data can be traced back to who observed, recorded, or entered it. This principle is crucial for ensuring accountability, enabling verification, and maintaining the integrity of data, especially in regulated environments like pharmaceuticals, healthcare, or any field where data accuracy and provenance are critical. By always tracing data to the responsible individual, organizations can manage data quality, address any discrepancies, and comply with various regulatory requirements that demand proof of who did what and when.
D. often traced to individuals responsible for observing and recording the data.
Attributable data is typically associated with individuals responsible for observing and recording the data. This attribution is important for accountability, data quality, and the ability to address any questions or issues that may arise related to the data. While there may be cases where data is not directly traceable to individuals (such as aggregate data or anonymized data), in many situations, especially in business or research contexts, it's important to attribute data to specific individuals or sources for transparency and accuracy.
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