T 38: Electronic Document Presentation During a Japan PMDA Inspection
Sr. Clinical Trial Manager
Gilead Sciences, Inc. United States
The objective of this case study was to develop an effective, electronic method of compiling, organizing, and searching for documents during a Japan PMDA Inspection.
In 2014-2015, Gilead Sciences participated in its first two PMDA Inspections in Japan. The first PMDA inspection was paper-based in which all documents were printed in advance. For the second PMDA inspection, documents were prepared and presented electronically to inspectors.
As required for each J-NDA, PMDA inspectors spend 1-2 days conducting a document-based inspection of the sponsor. The turnaround time is very rapid, with documents being presented within seconds of the request.
Gilead’s first PMDA inspection was paper-based. All documents associated with the study were printed, including all Controlled Documents (SOPs, Work Practices, Forms), all documents in the TMF, as well as informal documents such as emails or trackers.
Preparing and organizing the documents into binders were challenging and time-consuming. The number of binders was unexpectedly high: a total of 200 binders (equivalent of 55 feet tall, if stacked). All binders were assembled in the US, and during shipment to Japan, some binders were damaged or lost. Last-minute changes were difficult to accommodate. During the inspection, the binders were difficult to manage; the binders’ bulkiness made it hard to navigate to documents quickly. The large number of binders and paper documents created clutter on tables and throughout the room.
4 months later, Gilead’s second inspection was held, and the Regulatory team confirmed that PMDA would accept electronic documents during the inspection.
A predetermined folder structure and naming convention were developed for all department areas to follow. The complete Table of Contents (TOC) was printed into mini-booklets that corresponded with the folder structure. All 6,500 documents had unique number codes based on the folder organization.
3 laptops were prepared with all documents, and logistics were developed for presenting documents requested—without allowing perusal of other documents by inspectors.  The Interviewee and Navigator consult the TOC to identify the electronic folder number of the document (e.g. E01.02.01).  The Navigator opens and checks the document on the laptop’s primary screen.  The Navigator drags the document to the external monitor so that the inspector can review the document.
Instead of 200 binders full of paper documents, only 3 laptops were needed to store 6,500 files--about 15 GB total. The flexibility of electronic documents allowed for last-minute changes and for copies to be given to interviewees to prepare. Electronic documents resulted in an organized workspace during the inspection, without the clutter of binders and papers.
The Navigator role resulted in efficient, smooth delivery of documents requested by inspectors. Delivering documents requested by inspectors was more efficient, and a faster turnaround could be achieved than with the paper-based documents. Although all documents were loaded on each laptop, the logistics of presentation prevented the inspectors from viewing other documents that weren’t requested.
The electronic method of presenting documents to PMDA inspectors was recognized as a success by all participants, and Gilead will use this method for all future inspections.
Additional authors: Juan Betular, Kitty Yale