Attributable Data

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 refers to data that can be linked or attributed to a specific individual or entity responsible for observing or recording the data. In other words, it is data that can be traced back to the individual who created, accessed, modified, or deleted it.

The answer to the question is B - sometimes traced to individuals responsible for observing and recording the data. This is because not all data is attributable to individuals. Some data may be collected or generated automatically by systems or processes without any direct involvement of individuals.

However, in cases where individuals are involved in creating or handling data, it is important to have some level of traceability or accountability. This is particularly important in security administration, where it may be necessary to investigate security incidents or breaches and identify the individuals responsible for them.

Therefore, while not all data is attributable to individuals, it is important to have mechanisms in place to ensure that attributable data can be traced back to the individuals responsible for observing and recording it. This can include logging and auditing systems, access controls, and other security measures to protect data and maintain its integrity.