Examples of Source Documents in Clinical Research

Reliable source documents in clinical research include the first place a data point is recorded, such as electronic health records, laboratory reports, pharmacy logs, and patient-reported outcome diaries. For clinician-led visits, a strong source document must include the date of the encounter, specific physical exam findings, the patient's reported symptoms, and the investigator's clinical assessment. These records must be contemporaneous and attributable to ensure the integrity of the trial data during auditing.

Using Aduvera to generate these records removes the reliance on memory-based charting after the visit. By recording the encounter, the AI scribe captures the nuance of the patient's responses and the clinician's observations in real-time. This creates a high-fidelity first draft that the investigator can verify against the transcript, ensuring that the final source document is an accurate reflection of the encounter rather than a summarized approximation.