Case report form data management

The case report form (CRF) should be unambiguous and simple to use. Its completion should minimise the need for text. CRFs should consist of three modules. One module is common for all trials (laboratory data, etc.), one is common for all trials in the clinical programme for a given compound and one is specific to the study in question. In this way, data handlers become familiar with the forms and can therefore manage a larger number with fewer mistakes. A mechanism should be in existence to ensure that the clinician completes the CRF adequately. 

To develop a data management plan pertinent to the project, a checklist of the project material is necessary to enhance the planning. The items to be collected include the protocol, annotated case report forms (CRFs), literature, log-in and tracking forms, file structures, coding rules, CRF review conventions, query handling procedure, required edit checklist, central laboratory address/file format, laboratory normal ranges, clinically... 

MSHA s 1988 Coal Accident Analysis and Problem Identification Instruction Guide shows how a system of classification designed to collect premium data can become an artificial template that structures not only the activity of the inspection but also the conclusions that inspectors can draw from their data. The Instruction Guide provides a set of checklists, tally sheets, and planned inquiry sheets to help inspectors categorize accidents. The classification system in the Physical Barrier Analysis Matrix (Fig. 3.1) seems to support the conclusion that physical barriers are either not possible or practical in most of the cases reported on the form—a conclusion that might exempt management from responsibility for protecting workers. Because data from such an analysis directly affects policy and procedures, classification systems can have... 

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