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Review Board (IRB), a body composed of staff from the facility where the study will be staged, as well as a mandatory outside member, in order to study the detailed test protocol This document outlines the proposed project in ne detail The Informed Consent form signed by subjects is an important document in any study This form usually leans over backwards to outline the various hazards associated with the study and attests to the subject s or patient s free-will participation This is a far cry from practice as late as the early 1970s Industry in those years routinely carried out Phase I studies using prisoners Parke Davis and Upjohn in fact maintained a small freestanding joint Phase I clinic within the walls of the Jackson Correctional facility in Michigan.

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All such prison testing ended as a result of a number of court rulings that there could be no such thing as free-will participation among the imprisoned, because they were recompensed either monetarily, with time off their sentence, or other rewards The conduct of clinical trials too is governed by a set of FDA regulations This set of rules, known by the acronym GCP, set out detailed guidelines for all the steps involved in a clinical trial, from the content of the Informed Consent form to the format of the documentation that will be submitted to the agency at the completion of each phase In the ideal case, data from the Phase I trial will show that the candidate compound is well absorbed and almost entirely excreted in a reasonable amount of time.

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The recommended strategy for evaluating the project status is to begin by checking the value of the con dence factor to determine if the project is on track. The following questions should be asked regarding the con dence factor:

Observed blood levels in humans are in the range that produced the desired pharmacologic effect in test animals Test subjects, it will be further assumed, did not show any adverse effects until they had received a dose that was many multiples of the projected therapeutic dose These data inform the sponsor that the drug is safe; it is, however, still mute as to the compound s ef cacy Cancer chemotherapy agents are an exception to this as clinicians will be looking closely for tumor regression At this point the sponsor will submit the data to the FDA and schedule a Phase I to Phase II meeting Phase II clinical trials are intended speci cally as probes for therapeutic ef cacy This is the rst time that the new compound will be administered to individuals who will potential pro t from treatment, that is, patients.

Tactical Measures in Support of Global Strategies To support these global corporate goals, the CGO will reach out to experienced ROI teams, including the CFO and nancial analysts, to bring them into the core globalization team both to de ne the metrics and to measure them over time. These specialists will study international online business processes and work to improve metrics such as the following:

422 Gathering and Organizing Requirements Requirements describe the capabilities or features that need to be implemented in order for the software to achieve its purpose (solve a business problem, satisfy user needs, etc) Gathering requirements is one of the most challenging tasks in the software development process This is due to the size and complexity of modern software products, coupled with the dif culties customers may have when trying to de ne and then communicate requirements Requirements should be divided into several subcategories, such as business requirements, user requirements, system requirements, performance requirements, deployment requirements, upgrade requirements, security requirements, and so on Functional requirements describe the features of the software and the tasks it performs Nonfunctional requirements, also known as quality of service (QoS) requirements, describe properties that the system should display, such as performance, accessibility, or extendibility.

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