Drug Information Journal - March 2009 - (Page 133) Reusing Clinical Protocol Content to Improve Productivity MEDICAL INFORMATION 133 the original intent and meaning of their content to differ from one person to the next. As a result, efforts must be expended to discover the intentions of authors and to correct mistakes made when storing, retrieving, interpreting, reusing, and implementing information found in documents. These information discovery and error correction activities are not value adding; that is, they do not contribute positively to work output or its value. It follows that reducing or eliminating them will result in improved return on investment and productivity gains by freeing resources. Opportunities for improvement in this area are readily apparent when the repetitive activities necessary for formal information transfer and reuse are represented as a continuous cycle—the protocol information reuse cycle. At its most basic, the cycle of protocol information use and reuse can be described by five steps (Figure 2): 1. 2. 3. 4. 5. Information creation Information storage Information retrieval Information interpretation Information reuse FIGURE 2 5. Information Reuse 1. Information Creation The information reuse cycle in clinical research. See text for explanation. 4. Information Interpretation 2. Information Storage 3. Information Retrieval At each step in the information reuse cycle lies an opportunity for information to leak from the cycle, that is, for the transfer of knowledge to be interrupted or corrupted, such that work is required to resume the cycle. Note that the concept of information leak as used here is different from more common usages referring to intentional or unintentional disclosure of proprietary data or to the loss of key information-bearing employees. Definitions and examples of how information leaks from each step in the protocol information reuse cycle follow. STEP 1: INFORMATION CREATION The de novo creation of concepts that will be used to convey knowledge is information creation. In the document-centric environment, this information is created and conveyed in the context of documents, such as the research protocol. The cycle occurs when reused information (from step 5) is merged with de novo infor- mation (step 1), for example, to create a new protocol or a protocol-dependent document. An example of information leak at this step is the operational ambiguity created when one part of a document says one thing and another says the same thing in a different way or contradicts the first instance (7). Ambiguous language is a leak of information in the sense that readers of documents containing ambiguities require additional information to act on the documents as intended or else risk acting as not intended. Therefore, information leaks but is recoverable with additional work. Another common example of leakage at step 1 is the loss of rationale for certain choices made by authors that are difficult to ascertain from reading documents. Rationale is an easy target for noninclusion by document editors. For example, in the United States, inclusion of rationales for study design or procedure choices is not codified by statute (see 21 CFR 312.23), leaving subjective judgment and sparse therapeutic area-specific regulatory guidance as the only means of determining whether inclusion of a study design rationale is necessary. STEP 2: INFORMATION STORAGE Step 2 is the storage of the information created in step 1. Storage requires identifying the definitive instance of information (ie, the latest document version) to be stored. This is not trivial when multiple authors are involved, particularly Drug Information Journal
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