By Michael Stonebraker
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Extra resources for The Ingres Papers: Anatomy of a Relational Database System
This is one of the rare examples of where data flow for an EDC study is more complex than for a paper study. Even in studies conducted solely in the United States, questionnaires will be offered in languages other than English. Typically the CRF pages will be sent out to a certified translator. The least impact on the data management process can be achieved if the translator is instructed to keep the same questions on the same page. That is, if questions 1 through 10 appear on the first page in the English version, questions 1 through 10 should appear on the first page in the Spanish and Chinese versions.
These are often called repeating pages. See the discussion in Chapter 7, “Overseeing Data Collection,” for more information on data entry and tracking for repeating pages. Questionnaires Quality-of-life questionnaires introduce interesting considerations to the data management process. Questionnaires are one form of patient-reported outcomes and are to be filled out by the subject during a visit to the site. This is true for both paper and EDC studies. Because in EDC studies the subject won’t typically have access to the site’s computer, the subject fills out a paper questionnaire.
Some assessments, such as measurement of the primary infection site, appear on both days. A physical exam is not performed on either Day 3 or Day 4, but because this is only a portion of a full matrix, we can assume it is performed at some other visit. In addition to the procedures listed in a protocol visit matrix, there are some types of questions that always appear in a CRF, even if they are not explicitly called for in the protocol. These questions collect essential data that will be used both in analysis and in regulatory submissions.
The Ingres Papers: Anatomy of a Relational Database System by Michael Stonebraker