By Wallace M.
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The committee or czar may be the only ones empowered to define new objects and sometimes they are the only ones with permission to actually create those objects in the application. These committees have value in that they create a person or group that has good oversight over both the philosophy of database design and the particulars of the database objects used by all projects. Unfortunately, they can become unwieldy and delay work by not meeting frequently enough, by taking too long to produce a new object, and by not providing enough people with privileges to create objects (thereby causing difficulties when someone is out).
The same concepts also apply to electronic data capture (EDC) systems, but ideas specific to those applications will be addressed as they arise. The discussion of edit checks (data validation) is specifically not discussed in this chapter; see Chapter 7 for information on building and releasing edit check programs. ” For study setup in a CDM system, a data management SOP that describes the steps necessary to build, test, release, and maintain a database application for a study can act as the validation plan for all studies.
Since a Yes-only codelist offers little in the way of categorizing responses, some companies just use a single character to indicate that a box or field was checked. ” These groups then typically include additional discrepancy checking at, or after, entry to catch inappropriate values. Calculated or derived values Data from the CRF, electronic entry screens, and electronic files are not the only data associated with a study. There are internal fields that can be convenient and even very important to the processing of data that are calculated from other data using mathematical expressions or are derived from other data using text algorithms or other logic.