Data collection reporting form design

This section provides information on the personnel who should be involved in data collection and the design of reporting forms. The specific data needs for major incident analyses are discussed, together with the storage and retrieval of data for the purpose of analysis. 

Various forms have been developed to collect plant data. Figures 6.1 and 6.2 are generic forms published in EuReDatA Project No. 3. The Specimen Inventory form, Figure 6.1, is designed to collect data needed to establish the equipment description and total equipment population. Many maintenance systems offer some of these data, but usually not in a useful format or to the extent desired. The Specimen Event or Failure Report form, Figure 6.2, is used to capture failure event data that, when summed, will allow determination of the failure rate numerator—the number of failures within a unique plant population. 

Case report forms (CRFs) are used throughout clinical trials to record data collected during a trial. They record all of the information specified in the protocol for each subject (all data recorded on the CRF must be verifiable from original source documentation). While the traditional paper CRF format is still used, electronic data collection is becoming more common. Voorhees and Scheipeter (2005) discussed CRF development in detail, highlighting some of the fundamental aspects of their purpose, design, and nature ... 

The case report form is the vital record of a clinical trial. It is necessary to design the CRF to collect all the data required by the protocol. Carefully designed CRFs are essential for the following reasons ... 

The CRF design process can begin either following or concurrent with the protocol development. Well-designed data collection forms are critical to achieve the objectives of the clinical trial. Consideration should be given to the content, format, and layout of the forms since all these factors contribute to the overall quality and accuracy of the data that will be collected, processed, and reported. 

Because a number of conceptualizations of patient satisfaction can be used, the measurement of patient satisfaction must fit the context of the overall research process. A research process proposed by Churchill involves six stages 1) formulate the problem 2) determine the research design 3) design data collection method and forms 4) select a sample and collect the data 5) analyze and interpret the data and 6) prepare the research report. Each stage is linked, and decisions made at one stage will affect decisions made at other stages. 

Kinetic rate expressions are well known to exhibit hard-to-fit analytical forms. Moreover, most of them cannot be integrated to present a usable analytical form. We must therefore collect and fit data that reports instantaneous rates rather than cumulative concentrations. The use of kinetics to study reaction mechanisms is greatly hampered by these constraints. The only solution that can be envisioned is to acquire massive amounts of reliable, error-free, data. To achieve this we must clean up the raw experimental data by the skillful application of powerful methods of error correction. Only then is there the prospect that the data will reveal the underlying reaction mechanism. In the following chapters we present the necessary experimental methods for acquiring vast amounts of rate data and outline the early stages of the development of error correction techniques designed to deal with raw and noisy kinetic rate data. 

Any document used to collect research data on clinical study subjects may be genetically classed as a data collection form. These completed forms provide evidence of the research conducted. The most common type of data collection form is the CRF. Other types of data collection forms include diary cards, dispensing records, quality of life forms, etc. The CRF must allow for proper analysis of the data and proper reporting of the data in the final clinical study report and it must reflect the protocol exactly no more and no less data must be collected. Thus, a CRF must be created for each clinical study and must be prepared in parallel with the protocol. CRFs are usually also prepared by spon-sors/CROs in pharmaceutical industry research because of the demanding requirements for their design and contents. 

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