Regulatory Affairs Certification (RAC) Practice Exam

Which of the following is an example of raw data in a preclinical study?

1. A Final Pathology Report

2. B Records of quarantine and animal receipt

3. C Animal data entered into the animal chart

4. D Computer printout derived from data transferred to computer media from lab data sheets

The correct answer is: D Computer printout derived from data transferred to computer media from lab data sheets

The choice identifying computer printouts obtained from data transferred to computer media from lab data sheets represents an example of raw data in a preclinical study. Raw data refers to the original pieces of information collected from experiments before any processing, analysis, or interpretation occurs. In this context, the printouts that are extracted directly from laboratory data sheets are fundamental, unprocessed data that reflect the true experimental results. Conversely, the final pathology report and records of quarantine and animal receipt have undergone various forms of processing and may summarize findings or establish compliance, which do not constitute raw data. Similarly, animal data entered into an animal chart is typically a processed or organized version of the data collected during the study, making it no longer raw data. These types of documents may provide valuable insights or outcomes but do not qualify as the unprocessed, original data gathered during the study phase.