Abstracto

GCP-compliant digital archiving of paper-based patient records of clinical trial subjects: a key issues paper

Christian D Kohl, Insa Bruns, Mathias Freudigmann, Guido Scharf, Paul Schmucker, Gabriele Schwarz, Sebastian C Semler

Many healthcare providers digitize their paper-based patient records from routine care, destroying originals (replacing scanning). Current regulations are unclear as to which paper-based patient records may be destroyed after digitization if the respective patients participate in clinical trials. GCP-compliant destruction is possible if both sponsors and authorities recognize the digital copies as source documents. Recognition should be based on digitized paper-based patient records complying with the requirements for certified copies defined in ‘Note for Guidance – CPMP/ ICH/135/95’. This paper describes principles by which digitized patient records can be recognized as GCP-compliant certified copies, allowing the paper-based originals to be destroyed. A prerequisite is written proof that the digitization process implemented is controlled and its outcome quality is permanently monitored.