Good Clinical Practice (GCP) Practice Exam

Source documents in clinical trials are essential for verifying the integrity of data collected and ensuring the accuracy of the trial's findings. The correct choice includes clinical and hospital records, as well as laboratory notes, because these documents provide direct evidence of the subjects' medical history, conditions, and the results of tests performed during the trial. They are essential for the investigator to track patient progress and make informed clinical decisions consistent with the protocol.

Textbooks and literature reviews, while informative, do not provide specific data from the clinical trial context and therefore do not serve as source documents. Similarly, investigational drug pamphlets are designed primarily to inform participants about the drug's properties but do not contain individual participant data or direct evidence of trial conduct. Finally, trial protocol documents outline the trial's design, objectives, and methodologies, but they do not include primary data collected during the research. Hence, they do not qualify as source documents either.