IQVIA RIM Smart - Regulatory Information Management
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The Future of Documents: Structured Content and Integrated Data
Mar 11, 2022
Overview
Historically, regulatory submissions have used traditional document types such as formatted PDFs. The most common practice is to author documents in Microsoft Word and manually copy and paste data. This approach, however, is inefficient and creates inconsistencies. In many life sciences organizations, documents and data still exist in "separate worlds." Structured content can bridge the gap between documents and data. Component-based structured documents can be generated automatically for labeling, clinical documents like protocols and clinical study reports, and post market reporting. This approach increases patient safety by ensuring that data integrity isn't lost or corrupted.Context
Cham Williams, Julian Backhouse, Donald Palmer, and Jan Benedictus defined structured content and discussed how life sciences organizations can leverage it to enhance efficiencies and patient safety.
Key Takeaways
Structured content is a versatile source format that can produce many different digital outputs. Some say structured content is best defined by what it isn't. Structured content is not a formatted document that has been optimized for consumption in a specific form like a PDF or a Word file. Instead, it is a versatile source format for storing content. Organizations can use that content to produce a variety of digital outputs. Structured content has three characteristics:
- It is defined by its structure. Structured content always has a schema, a set of rules that the content must adhere to.
- Many schemas include components. Teams often use component-based authoring in conjunction with structured content authoring.
- Structured content uses semantic tags. Product data, for example, might include a semantic tag called "product." In contrast, unstructured content might be formatted using font sizes, margins, or line heights.
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