Good Documentation Practice (GDP) refers to standardized methods for creating, correcting, and maintaining clinical research records so they remain accurate, complete, and reliable.
GDP aligns with ALCOA(+) principles to ensure entries are attributable, legible, contemporaneous, original, and accurate, with traceable corrections when needed. It applies across source documentation, regulatory files, data corrections, and essential trial records. Strong GDP reduces data integrity risk and supports credible analyses and submissions. Auditors and inspectors depend on GDP-compliant documentation to confirm that trial conduct and results are trustworthy.