Source documents constitute the original records where clinical trial data are first recorded, serving as the foundational evidence that supports all data entered into case report forms and included in regulatory submissions. These documents provide the verifiable trail of evidence that enables regulatory authorities, auditors, and monitors to confirm that the data underlying efficacy and safety conclusions accurately represent what was observed during the trial. The integrity of clinical trial data ultimately depends on the quality, completeness, and accessibility of source documents.

The range of documents that may serve as source data is extensive and depends on the specific assessments and procedures conducted in the trial. Common source documents include hospital medical records, physician office charts, laboratory reports and printouts, imaging reports and films, electrocardiogram tracings, pharmacy dispensing records, patient diaries, and questionnaire responses. Electronic health records increasingly serve as source documents, requiring attention to system validation, access controls, and audit trail functionality to maintain data integrity. Any document where observations are first recorded may constitute a source document.

Source documents must be attributable, legible, contemporaneous, original, and accurate, principles often summarized by the acronym ALCOA. Attributable means that data can be traced to the person who generated it and the time it was created. Legible means that data can be read and understood now and in the future. Contemporaneous means that data are recorded at or near the time the observation is made. Original means that data represent the first recording rather than a transcribed copy. Accurate means that data correctly represent the observation made. Some organizations extend these principles to ALCOA+ by adding complete, consistent, enduring, and available.

Any corrections to source documents must be made in a manner that preserves the original entry, demonstrating transparency and maintaining data integrity. For paper documents, this typically involves drawing a single line through the error without obscuring the original text, entering the correction nearby, providing an explanation if the reason for the change is not obvious, and including the date and initials of the person making the correction. Electronic systems must maintain audit trails capturing the same information. Source documents must be retained for the regulatory-required period, which typically extends many years after trial completion, and must remain accessible for potential inspection.

Source documents constitute the original records where clinical trial data are first recorded, serving as the foundational evidence that supports all data entered into case report forms and included in regulatory submissions. These documents provide the verifiable trail of evidence that enables regulatory authorities, auditors, and monitors to confirm that the data underlying efficacy and safety conclusions accurately represent what was observed during the trial. The integrity of clinical trial data ultimately depends on the quality, completeness, and accessibility of source documents.

The range of documents that may serve as source data is extensive and depends on the specific assessments and procedures conducted in the trial. Common source documents include hospital medical records, physician office charts, laboratory reports and printouts, imaging reports and films, electrocardiogram tracings, pharmacy dispensing records, patient diaries, and questionnaire responses. Electronic health records increasingly serve as source documents, requiring attention to system validation, access controls, and audit trail functionality to maintain data integrity. Any document where observations are first recorded may constitute a source document.

Source documents must be attributable, legible, contemporaneous, original, and accurate, principles often summarized by the acronym ALCOA. Attributable means that data can be traced to the person who generated it and the time it was created. Legible means that data can be read and understood now and in the future. Contemporaneous means that data are recorded at or near the time the observation is made. Original means that data represent the first recording rather than a transcribed copy. Accurate means that data correctly represent the observation made. Some organizations extend these principles to ALCOA+ by adding complete, consistent, enduring, and available.

Any corrections to source documents must be made in a manner that preserves the original entry, demonstrating transparency and maintaining data integrity. For paper documents, this typically involves drawing a single line through the error without obscuring the original text, entering the correction nearby, providing an explanation if the reason for the change is not obvious, and including the date and initials of the person making the correction. Electronic systems must maintain audit trails capturing the same information. Source documents must be retained for the regulatory-required period, which typically extends many years after trial completion, and must remain accessible for potential inspection.