Data management items required

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... 

One potential explanation for an apparent failure of reductionism is simply the manner in which manpower has been organized (i.e., the research infrastructure) to attack problems of the magnitude of those considered, for example, by the National Research Council panel noted earlier. With some exceptions, the majority of funded research efforts is short term and involve very small teams. Is it possible that the amount of information to reduce is too much to produce results that would be characterized as success (i.e., does the equivalent of an undercapitalized business venture exist ) It is further observed that the value of reduction is often only demonstrable by the ability to assemble. As noted, the prime tool of assembly thus far has been statistical in nature and relatively few causal models have been seriously entertained. With regard to human systems, it is clear that there are many such items to assemble and many details to consider if assembly — with high fidelity— is to result. Furthermore, it is clear that tools (i.e., special computer software) are needed to make such assembly efforts efficient enough to consider undertaking. Has the data management and analytic power of computers, which have only been readily available in convenient-to-use forms and with required capacities for less than a decade, been fuUy exploited in a fair test of reductionism ... 

One particularly stark example of the importance of an end-to-end project management authority, or at least consensus on the appropriate transition point, is in the development of medical countermeasures See Box 5.1 highlighting some failures of medical products where poor transition between development stages was a contributing factor). The root of the difficulty is that development and acquisition of these items must contend with regulatory requirements— e.g., good laboratory and manufacturing processes, clinical trials, and acquisition of safety and efficacy data—and these requirements must be met in order to obtain FDA approval of the final... 

It was also stated in Chapter 1 that Section 7.0, the Management Review section, was a close second in importance. Maintaining superior management leadership requires that evaluations be made of the effectiveness of safety processes so that improvements can be made where necessary. The Management Review provisions in ZIO require gathering, at least annually, the data necessary to assess The performance of the occupational health and safety nnanagement systems relative to expectations. Action items for improvement are to be drafted as that performance assessment is made. 

The expected supervision scale has 6 items, and both versions are shown in Table 9.6. Scale items were developed based on the discussion of supervisor behavior required to ensure new employee safety in Chap. 4, Sect. 4.2.8. At the time of writing, no data on the psychometric properties of this scale had been collected. As noted in Chap. 3, supervision of new employees should be a specific task assigned to supervisors. Furthermore, new employees are likely to expect that supervisors will be there to ensure their safety. As noted in many places in this book, the perception that a system has a component which is there to protect a person from risk can lead to more risk being taken. Thus, it is very important that new employees have a realistic perception of the degree of supervision that they will receive. It is also important to note that employees (job incumbents) are asked to complete this scale—not supervisors. Employees should be able to respond to the items in terms of the experiences they have had with supervision, whereas supervisors may respond in terms of what higher management expect of them, rather than their actual supervision of new employees. 

The DAL deliverables (called Data Items ) which need to be managed, and what is required of them (i.e., the objectives they should meet to satisfy the allocated DAL). 

The HCF Department Manager is responsible for specifying the requirements, responsibilities, and implementation plan for documenting equipment maintenance histories. Specific equipment for which maintenance histories will be required is identified in the HCF MEL Material history data for such equipment will be used for planning, sdieduling, and performing maintenance on these items and to provide information for evaluation. The Site Maintenance Plan describes how similar information Is captured within the FOE work control system. 

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