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What is meant by "Source Data" in a clinical trial?

Data collected from survey responses

All information in original records necessary for evaluation

"Source Data" refers to all information that is recorded in original records or certified copies, and is necessary for evaluating the integrity and credibility of clinical trial results. This includes data originating from various sources such as patient medical records, lab results, and any other documentation that provides evidence supporting trial findings.

Having accurate and complete source data is vital as it validates the information collected during the trial, ensuring that it can be relied upon for making conclusions about the efficacy and safety of the treatment being studied. This concept plays a fundamental role in maintaining data integrity and supports compliance with regulatory requirements.

The other choices, while related to data in a clinical trial, do not accurately define "Source Data." Survey responses might be one form of data collection but do not encompass the full scope of source data. Statistical analysis pertains to the processing of data rather than its origin. Lastly, data presented in the final study report is synthesized and interpreted information, distinct from the raw source data collected throughout the trial.

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Statistical analysis of trial results

Data presented in the final study report

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