Applying ICH Good Clinical Practice to Clinical Documentation

ICH Good Clinical Practice (GCP) requires that clinical trial data be ALCOA: attributable, legible, contemporaneous, original, and accurate. In practice, this means notes must clearly document the date of the visit, the specific interventions performed, and the patient's responses without ambiguity. Strong GCP documentation avoids retrospective reconstruction and ensures that any auditor can trace the final report back to the original source encounter.

Aduvera supports this standard by recording the encounter in real-time, removing the reliance on memory-based drafting. Instead of starting from a blank page, clinicians review a high-fidelity draft backed by transcript citations. This workflow ensures that the final note is a precise reflection of the encounter, facilitating a more reliable review process before the note is finalized in the EHR.