1. - A “Portable” Implementation
The Reference Model
- A “Portable” Implementation
Jimmy Chen
Product Manager, ROSETTA eCTD Software

2. Disclaimer
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated.
These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.

3. 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.

4. 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

5. 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.

6. 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?

7. 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?

8. 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

9. Document Properties in Microsoft Word

10. Document Properties in PDF
PDF stands for Portable Document Format.

11. 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

12. 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)

13. (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

14. 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