Drug Information Journal - March 2009 - (Page 135) Reusing Clinical Protocol Content to Improve Productivity MEDICAL INFORMATION 135 Protocol Blood will be collected for PK sampling at {Visit 1}. Study Guide FIGURE 3 Reuse of extensible protocol content. Idealized view of document content reuse in two related documents, the research protocol and study guide. The data element named Visit 1 is given meaning within the context of a protocol knowledge model. The Visit 1 concept may be accessed from a single protocol model instance and reused in multiple documents and information systems multiple times, through humandirected or automated data transfer, while preserving its authors’ original meaning and usage intent. PK, pharmacokinetics. The {Visit 1} lab kit includes a red-top tube for collection of serum for drug PK sampling. {Visit 1} Blood Sample PK Visit 2 Etc. Visit 3 Etc. {Visit 1} Protocol Model Instance PK Sample {Visit 1} ECG Visit 2 ETC. Visit 3 Blood will be collected for PK samples at the following visits: • {Visit 1} • Etc. ers, conversely, have historically not been able to infer the structure of information from its form or content alone. Therefore, in order to improve computer facilitation of knowledge transfer, it was necessary for information scientists to create so-called markup language conventions that confer explicit structures to information components. Once an explicit structure was present, computers could assist in the interpretation and analysis of document content, much as they had historically assisted with analysis of numerical and character data collected during research studies, which were stored in and accessed from relational databases. Documents whose key concepts are represented within a formal hierarchical structure can be considered to be semantically modeled, in that the concepts have been abstracted in a manner that confers meaning on them (9). If implemented ideally, such meaning will be highly domain relevant and unambiguous to domain specialists. Structured information does not usually contain the nuances and idiosyncrasies that make natural language a delight to explore creatively, but being delightful is not a required property of research documents. And there are no restrictions against using natural language around structured information in a document to provide readers with enhanced context and readability. As a trade-off for time spent creating mixed structured and unstructured documents, maintaining and transmitting structured information with computer assistance reduces risks of information degradation and loss over time, space, and knowledge domain. THE EXTENSIBLE PROTOCOL The information interpretation step (step 4) is particularly amenable to computer facilitation. Indeed, if a research protocol is sufficiently information dense, and all relevant information is structured, use of appropriate tools could theoretically eliminate the need for human interpretation of key concepts among authors and users, reducing the five-step reuse cycle to a four-step cycle (Figure 3). The benefits of reducing or eliminating information interpretation become self-evident when considering the transfer of information from the protocol (via protocol authors) to downstream systems such as EDC. In the case of EDC setup specifically, a clinical data domain expert is usually asked to interpret the protocol before coding the EDC system to create the nec- Drug Information Journal
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