Types of Data Collected

In the first of the following subsections, the data coDection approaches adopted in most CPI incident reporting systems will be described. The fact that these systems provide little support for systematically gathering data on underlying causes will provide an introduction to the later sections which emphasize causal analysis techniques. 

Data Collection Practices in the Chemical Processing Industry 

The following types of information are collected in most CPI safety-related data collection systems  

This typically considers injuries to personnel and damage to plant and equipment. In a few more highly developed systems, information on potential consequences is also collected. Normally the severity of the incident consequences (or in some cases its potential consequences) will determine the resources that are put into its investigation. 

This describes any work permits associated with the work relevant to the incident. 

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The model of human error held by management and the plant culture constitutes the environment in which the data collection system operates. Within this environment, all data collection systems need to address the topics listed in Figure 6.1. These topics, from the types of data collected, to the feedback systems that need to be in place, will be addressed in subsequent sections of this chapter. 

The discussion of alternative types of data collection systems serves to emphasize the fact that the design of such systems needs to have very clear objectives. Although a range of data collection systems have been described as if they... 

The type of data collected on human error and the ways in which these data are used for accident prevention will vary depending upon the model of error and accident causation held by the management of an organization. This model will also influence the culture in the plant and the willingness of personnel to participate in data collection activities. In Chapters 1 and 2 a number of alternative viewpoints or models of human error were described. These models will now be briefly reviewed and their implications for the treatment of human error in the process industry will be discussed. 

Specify Data Collection Methods and Responsibilities Several types of data collection have been specified in earlier sections. It is important that the responsibilities for operating the various aspects of the system are imambiguously defined. 

Although it is possible to identify and test every scenario of consistency checks, a business decision has to be made as to the depth of the checks. However, it is essential that all serious scenarios that could affect data analysis be tested. This is true for any type of data collection system. However, for a system to be one hundred percent reliable, every scenario must be tested and dealt with appropriately. A scenario that cannot be predicted at the time of development may be incorporated into the system or handled as an exception and dealt with accordingly when it occurs. 

In a similar type of data collection, during 2000 to 2001 Wozniak (2002) examined the incidence of anabolic hormone residues in 5393 animals, consisting of cattle, pigs, horses, rabbits, chickens, geese, turkeys, ducks, and fish. Wozniak assayed for residues of diethylstibestrol, hexesterol, dienestrol, zeranol, trenbolone, and 19-noresterone. In addition, 632 cattle and swine were assayed for medroxyprogesterone and 1176 were assayed for natural 17-p-estradiol and testosterone. In only three heifers and two cows did serum testosterone exceed the MRL (EC 0.5 pg per liter) two bulls and four cows had an increased content of 17-(3-estradiol in their blood. A total of 11 animals of the 5393 examined (0.2%) had excessive quantities of hormone materials in their system. None of the other animals showed evidence of the presence of... 

Human pharmacology studies are designed to collect data that can be compared with similar types of data collected in nonclinical studies. Acute singledose studies are conducted first, with the dose used based on extrapolation from... 

The management of safety data requires not only all the care that management of every other type of data collected requires (recall Section 5.9) but also some extra considerations. The first of these is the process of coding. To facilitate the summarization of AE data that are collected in the subjects own words (or the investigators version of their words), and can therefore be heterogeneous, a degree of uniformity has to be introduced. For example, the terms headache, ... 

As you can imagine from what I have just said, most of the data had to remain confidential, because the women had spoken to the committee on this condition, and because the number of women is so small that they can usually be identified as individuals from the other types of data collected. The data on space and research volume were considered too confidential by the departments even to be shared with the whole committee and were collected instead within each department, shown to me as chair of the committee, and placed only in the dean s and president s copies of the report. The only data that could easily be released were the data on the relative numbers of men and women at various career levels. 

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... 

There are two ways to classify the types of data collected—subjective and objective. Subjective data refer to all information provided by the patient that cannot be confirmed independently. The weakness of subjective data is that it cannot be confirmed, observed, or measured by the interviewer. However, it can be validated by other means. For example, patient compliance with a medication regimen can be supported by talking with a family caregiver however, this is also subjective. 

When is it permissible to deny some benefits, or put some subjects at risk, for the sake of research and the benefits it promises For example, when is it permissible to perform cost-containment research, and what type of peer review and informed consent is necessary ° This is particularly relevant for pharmacists because many are involved in this type of data collection and analysis. It is possible that some subjects may receive a lower standard of care than that to which they are accustomed. Thus, experimental strategies that reduce services may expose subjects to the possibility of harm without benefit. 

As in university or academic-based drug information centers, published literature used to develop an answer to a drug information inquiry can be divided into primary, secondary, and tertiary sources. Primary sources are the most desirable type of data to use and can be subdivided, depending on the type of data collected. Information gleaned from randomized, prospective, double-blind trials result in data more useful than just one case report on a given topic. Ideally, the most rigorous data available are used however, case reports and abstracts may be the only available literature published. Peer-reviewed, well-respected journals should be used. 

Discussions in this chapter emphasize statistical considerations in early phase clinical trials. These include study designs employed, the types of data collected, and the usefulness and limitations of these data. 

Rotational motion exerts fluctuating magnetic fields on the electron spin and also averages the various tensor components (see Fig. 2). Nitro-xide EPR spectra are profoundly influenced by the rate of this motion relative to the range of electron spin precession frequencies within each hyperfine line. Thus, one can use EPR spectroscopy to determine tr accurately. There are distinct temporal regimes in which spin label spectra require different types of data collection methods and data analysis to achieve this. These regimes are discussed below. 

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. 

Why As part of a PDSA cycle, a survey is a type of data-collection process that focuses on getting information from people to answer a question(s) posed in the planning phase of the cycle. 

A study that is incomplete at the time of filing must be disclosed to the EPA, together with any preliminary results, a description of the nature and purpose of the study, name and address of the laboratory, progress, types of data collected, and anticipated completion date. The PMN submitter must submit the study if it is completed during the ninety day PMN review period. The PMN submitter must submit it within ten days of receiving it, but no later than five days before the end of the PMN review period. If the study is... 

The log section of fieldnotes includes the factual information regarding the date and site of data collection, the type of data collection (covert participant observation, focus group interview, document analysis of student evaluations, etc.), the names of both the research subjects and the researchers collecting the data, and a statement of the purpose of this data collection activity. 

An important aspect of mixed method designs is the priority of the quantitative and qualitative approach. In other words, does one research approach have a dominant priority over the other or are they of equal priority The emphasis of either approach is dictated by the intent of the researcher and the goals of the study. In a practical sense, the first type of data collection usually has the dominant priority. For example, in the Mulford and Robinson... 

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