Initial reviews, planning

NICE has an initial review plan for a wide range of products, including many new and existing medicines, medical devices, diagnostic and surgical procedures. 

A source apportionment study using the receptor model should include interpretation of the chemical data set by both multivariate and chemical mass balance methods The most critical steps in a receptor model study are the initial review of potential source characteristics and the development of an appropriate study plan. 

Unexpected findings with animal feeds poor in inorganic arsenic and speculation of the possible essentiality of arsenic due to its position in the Periodic Table below phosphorus and next to selenium (both of which are known for their essential properties), led to the initiation of plans to study arsenic deficiency in experimental animals. Some earlier experiments, however, were unsuccessful as initially it was impossible to prepare correct arsenic-deficient diets. This was later achieved by Anke and coworkers (Anke et al. 1976a, b, 1987, 1990, 2001) in studies with goats and minipigs, and by researchers of the U S Department of Agriculture with rats, chicks and hamsters (Nielsen et al. 1975 cited in Uthus 1992, and reviewed by Uthus 1992, 1994, and Nielsen... 

Complete detailed design, including optimization and final cost estimate. Initiate fabrication planning and preparations. Complete safety analysis report and reviews and approvals. Obtain construction permit... 

Occupational safety and health management system documentation Communication Planning and implementation Initial review... 

The reservoir model will usually be a computer based simulation model, such as the 3D model described in Section 8. As production continues, the monitoring programme generates a data base containing information on the performance of the field. The reservoir model is used to check whether the initial assumptions and description of the reservoir were correct. Where inconsistencies between the predicted and observed behaviour occur, the model is reviewed and adjusted until a new match (a so-called history match ) is achieved. The updated model is then used to predict future performance of the field, and as such is a very useful tool for generating production forecasts. In addition, the model is used to predict the outcome of alternative future development plans. The criterion used for selection is typically profitability (or any other stated objective of the operating company). 

The assessor should establish whether the toller initiates regular formal (minimum biannually) performance review meetings with the client. Look for minutes, action plans, etc. 

I am pleased to announce that the Management Committee has designated (corporate safety director) to lead the development of our companywide PSM initiative. In this capacity, (name) will be responsible for recommending a detailed plan of action for review and approval by the Management Committee. Our expectation is that, once approved, the plan will be tested at a selected site to be determined, and ultimately implemented throughout the company. 

Undertaking a PSM initiative will requite time, staffpower, and funding— direct and/or indirect. The task team s first priority will be to develop a detailed plan for the Core Management Group s review and approval, including specific schedules and cost estimates. 

At this point in the process, you may find it useful to review the preliminary plan you presented for initial management approval (see Chapter2). That "first take" necessarily lacked the detail you are now able to provide. For example, your initial estimates of time requirements might have predicted 18 months for system design and installation now you reali2e that 24 months will be needed. While the initial plan will require changes, it should have components (organizational, stylistic, narrative) that can be adapted for use in the formal plan. 

A Initially a team of five or six will develop a detailed proposal. We will then select a division for a pilot study. The pilot will have a team of about 12 people, half of whom will be full-time. As the integration is rolled out in other divisions, I expect a slightly lower level of effort, as we will have learned from our earlier experiences. We will also use an outside consultant to help us develop our plans and review implementation. 

Most consent forms that have been developed have at some time been reviewed by standing ethical review boards, usually associated with a university. The format of the consent form described above has been reviewed over time by more than one ethical review board and would be acceptable in most States for the purpose of acquiring the consent of potential volunteers in a worker exposure or re-entry study. If performing worker exposure studies in California, the researcher is advised to contact the State regulatory agencies and submit the draft consent form and study protocol to the State-appointed ethical review board for review and approval prior to initiation of the field phase of the study. Of course, if the researcher has any doubt about the acceptability of the proposed consent form, he/she should contact the appropriate state agencies where they plan to perform the study. 

Several recovery scenarios were considered for remediation. Initially, construction of a narrow, permeable trench parallel to the canal appeared to be an appropriate interception system. The construction technique considered was use of a specially designed deep trenching unit. This type of trench would have included a tile drain leading to a single two-pump recovery well. However, a review of the subsurface site plans and interviews with long-term employees determined that an unknown number of buried pipes traverse the area intended for the trench construction. Disruption of refining operations and safety considerations resulted in rejection of this option. 

In June 1993, the Center for Devices and Radiological Health (CDRH) introduced tier/triage management initiatives to improve the efficiency of its administrative and scientific review of premarket applications. One key item in this plan was introduction of a tier/triage process for 510(k) applications. This proposal was designed to allow levels of 510(k) reviews adjusted according to the device risk. Three review levels were proposed as follows ... 

An outline of the data from non-clinical studies must be submitted to the PMDA with the protocol for the proposed clinical study before commencing the clinical trial. A notification is required for each protocol. The list of items required for Clinical Trial Plan Notification is shown in Table 23.4. Furthermore, supplementary data must be added on entry to subsequent clinical phases, that is, general clinical trials and comparative trials. Such data are reviewed by the PMDA, and for this purpose the sponsor must wait for 30 days after submitting the initial notification before executing a contract with the medical institute. For a subsequent notification, the review period is reduced to 14 days. The notification also... 

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