2019 Volume 50 Issue 3 Pages 81-86
Background: This study aims to systematize quality assurance and document management support to ensure the smooth implementation of investigator-initiated clinical trials (IITs).
Methods: A sample survey was performed to investigate whether and how signed original informed consent (IC) documents for IITs were stored at Kanazawa University Hospital. Based on the findings, initiatives were implemented utilizing an electronic medical record (EMR) system: 1) The latest versions of IC forms were issued directly from the EMRs for version control. Forms were printed with a 2D barcode to facilitate their re-entry into subjects' medical records. 2) A new management protocol was introduced in the clinical trial support office to ensure consistent uploading processes for signed IC documents and the archiving of paper records. 3) Patients were registered to trials individually using their EMRs, enabling investigators to access their consent and progress statuses in one place. After implementing these initiatives, the storage of signed original IC documents was re-assessed.
Results: The EMR system presented a simpler IC document management compared to the conventional approach. The updated post-consent document handling procedure improved and consolidated signed original IC document archiving. In addition to the separate registration of trial subjects, investigators responsible for the trial were explicitly identified in the EMR system in the event of uncertainty in other departments. This approach allows for easy confirmation of subjectsʼ consent status when preparing and administering trial drugs.
Conclusions: Our approach of consolidated document and trial process management can improve the reliability of clinical research.
