Continuous review

The Standard-Setting Process. Settiag USP-NF standards is a continuing, and by no means unilateral, process. The Committee of Revision not only develops monographs for new substances but also continually reviews the monographs, specifications, and testing methods for existing substances. Results are pubHshed in one or more supplements each year. A complete review is done every five years and a revision is pubHshed. 

Creative thinking is important not only in new process development, but also in continually reviewing and reevaluating existing processes for opportunities to make the process inherently safer. Many of the tools and techniques discussed in Section 4.2, on Research, are useful in the process development stage as well. It is appropriate to revisit the basic chemistry to study alternate options. 

In addition, it is necessary to determine the time span of the design project and also assess how the Q system wiU be continuously reviewed and updated due to changes in the process, product recipe, legislative requirements, and other factors. 

There are three features of a linker that will determine which support is applicable to a synthetic scheme (1) the functionality of the molecule at the anchoring position required for attachment (2) cleavage conditions and (3) the resulting functionality at the anchoring position of the molecule after the cleavage. As a continuing review on resins and linkers, this discussion will focus on the work that has been developed from 1997 to 1999 (Refs. 6-9 and references cited therein) and is described according to... 

IRBs must conduct continuing reviews of research they approve at least once each year. More frequent reviews may be required if the risk of a particular research project so warrants. IRBs have the authority to suspend or terminate approval of research that is not being conducted in accordance with their requirements or that has been associated with unexpected serious harm to subjects. Such action must be accompanied by a statement of reasons for it and be communicated to the investigator, appropriate institutional officials, and the Secretary of HHS. 

The reduction in the lead content of gasoline and the introduction of reformulated gasoline have been very successful in reducing automobile emissions, due to changes in gasoline composition, with further improvements in fuel quality proposed for the early decades of this new millennium. These projections are accompanied by a noticeable and measurable decrease in crude oil quality, and the reformulated gasoline will help meet environmental regulations for emissions for liquid fuels but will be subject to continuous review because of the potential for environmental impact. 

The potential of any chemical for environmental damage must be assessed before its commercialization, and our capability for doing so, should be expanded, although we recognize the possibihty that the new chemical might replace another substance, natural or manmade, already in use that could be even more damaging. Those cases demonstrate the need for continuous review of costs and benefits, which might not be the same for all countries and communities. 

Another supportive role that management must accept is the provision for additional resources when QAU responsibilities are increased either by management, by revised or new regulations, or by increased study workloads. Such resources include personnel, office space, equipment, clerical support, etc. Management must continually review and balance the allocation of resources to the quality assurance and scientific study areas to efficiently operate with the desired level of quality. 

Assure the initial and continuing review and approval of the investigation by an appropriately constituted IRB. 

Provide initial and continuing review of research involving human subjects provide written reports of findings and actions to the investigator and the institution. 

We must decide that men and women will share decision-making roles at every level of our institutions, and that women and men together, chosen by the women faculty as a group, will continuously review data pertaining to resources and compensations to ensure equity. 

IRBs are also governed by federal and state law. FDA regulations require IRBs to provide initial and continuing review of clinical trials [16]. IRBs must ensure that investigators and sponsors protect the study subjects, obtain adequate informed consent, and adhere to other safeguards and reporting requirements [16]. Moreover FDA regulations require IRBs members to meet specific membership criteria [17]. 

Individuals who have responsibilities in the chemical process industries are usually engaged, consciously or otherwise, in continually reviewing their operations to ensure that they are safe, efficient, and in compliance with current environmental regulations. They are also, or should be, anticipating future needs. It is hoped that the information contained herein will provide the wherewithal by which chemists, chemical engineers, and others who have a peripheral interest in the process industries, for whatever reason, can ensure that they have touched every base, dotted every i, and crossed every t in their quest to make the processes and products for which they are responsible as environmentally sound, safe, and efficient as possible. 

Because IRB review/approval and continuing review processes are required for all clinical investigations performed in support of a research application or a marketing permit for FDA regulated products, it is important to assure that projects are not initiated before these approvals are obtained. 

Conducting initial review and continuing review/approval of research. 

Lack of documentation to verify that the IRB provided continuing review of research activities that it initially approved at intervals of no less than one (1) year, but appropriate to the level of risk to the subject. 

Document review prior to study initiation Investigator qualifications by a CV Continuing review of investigation Financial, coercion/undue influence Membership Written procedures... 

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