- A “Portable” Implementation The Reference Model - A “Portable” Implementation Jimmy Chen Product Manager, ROSETTA eCTD Software jimmy.chen@doublebridge.com

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From the Reference Model project charter… …taxonomy/metadata reference model… should be applicable in all settings, from the simple file share to the complex enterprise system … DoubleBridge’s ROSETTA eCTD software supports enterprise electronic document management systems. However, my presentation will focus on the simple file share or simple file systems which are important but sometime may be neglected by some.

Simple File Share vs. Complex EDMS Electronic Document Management System (EDMS) For many companies, this is where documents are created Supports custom taxonomy, metadata, workflow, security, …etc. Commercially off-the-shelf EDMS is the best choice to implement the Reference Model File share, CDs and DVDs (Plain File Systems) Most common media for the transfer of documents Can not be extended to support custom attributes For many smaller companies, file share is the only viable option

Inevitable use of plain File Systems Submission documents created in an EDMS They are created to go out of EDMS Transfer of electronic submission documents published from an EDMS to a file share prior to being transmitted to regulatory authorities between collaborating companies in a joint venture between a sourcing company (CRO) and its clients for litigation/discovery purposes loaded into a tracking or archival system from file share, CDs or DVDs For many companies that use EDMS, the copy on a controlled file share or CDs/DVDs are considered as the official copy. They are what sent to regulatory authorities In some cases, depending on the choice of EDMS, they are the copies that have the document links work.

Portable implementation of the RF Electronic submission documents, at certain point in time, live in plain file systems Portable taxonomy isn’t a problem How to make metadata portable (i.e. not to lose them) during transfer from an EDMS to a plain File System?

Storing document metadata in a Plain File System? No, you can’t – at least not directly. Plain File Systems can not be extended to store custom metadata/properties of a file To make the metadata ubiquitously portable, a document’s metadata should live within the document Where do you think the length of a video clip is stored?

Storing document metadata in a document Yes, you can! The capability is readily available in many file formats Microsoft Word (.doc) Adobe PDF (.pdf) Picture (.jpg, .jpeg) Many file formats support custom properties Standard: Title, Subject, Keywords, Author, … Custom: name your own properties

Document Properties in Microsoft Word

Document Properties in PDF PDF stands for Portable Document Format.

What if the file format does not support “Document Properties”? Solution: Describing a document in the context of the doc An eCTD example: storing document properties in the eCTD backbone. Storing document properties in the keyword attribute of a leaf node in the eCTD backbone files Doc properties are, indeed, keywords The keywords attribute values are not validated by eCTD validators Using name=value pairs in the keywords attribute to preserve the meanings of values and facilitate automation Metadata are now portable with the eCTD submission

Uses of portable document properties Building eCTD backbone files Documents can be indexed automatically when imported into another repository or EDMS Search tools: search for documents by properties without relying on EDMS or full-text search engine Tools are available to preserve document metadata when rendering documents from one format to another (e.g. .doc > .PDF)

(Embedded) Document Properties can be used to build eCTD backbones For smaller companies: Provide Word templates with pre-defined custom attributes Provide attribute values prior to the request for contribution or ask the author to fill in attributes values Select a rendering tool that can preserve document properties when a doc is converted from .doc to .pdf Alternatively, document properties can be supplied by the assembler of eCTD submission Use DoubleBridge’s ROSETTA Scribe to build eCTD backbones from a set of PDF documents

Summary and Recommendations Use EDMS to implement the Reference Model whenever possible Document’s metadata are part of a document. Metadata should follow where the documents go Preserve metadata in your publishing and information exchange processes by writing to Document Properties if the file format supports it Don’t let vendor tools hold your document metadata as hostages. Demand your tool vendors to set them free. Visit booth #401 to see how DoubleBridge’s ROSETTA eCTD software supports and implements Reference Model in a portable way