Summary 59 Integrative Example

From this analysis an event story was constructed, in part to integrate the findings from the various analysis methods, but also to make the information accessible in a chronological format to developers. Figirre 13.5 shows a summary and example of how the video/audio irrformation was gathered from footage into the three analysis methods. 

CTD, but there was concern, for example, that the FDA would still retain an additional regional requirement for the Integrated Safety Summary (ISS) and Integrated Efficacy Summary (lES). 

A summary of results from experiments exploring the scope of catalytic AD is presented in Tables 6D.2-6D.6. The results are divided according to the five substitution patterns for which useful levels of enantioselectivity have thus far been achieved so that the synthetic chemist can easily compare a potential candidate for AD with the existing precedent. Our emphasis in this chapter is on the best conditions currently available for a general catalytic AD process, because this is very likely of the most practical interest to the reader. However, Tables 6D.2-6D.6 include most of the published data from the Sharpless laboratory for AD under a variety of conditions. These data are included to permit the reader to place in context results reported in several publications and to illustrate the variety of olefins that have been used at least once for an AD reaction. Additional applications of catalytic AD reported in the literature are integrated into the discussions of the different olefin categories. Examples illustrating double diastereoselectivity" are collected and discussed in a separate section. 

The quality of a submission depends not only on the content of the submission but the tools provided to facilitate the review process. Now more than ever, FDA reviewers are receptive to electronic review aids and the use of electronic files. Simple and relatively inexpensive approaches are available. Important issues to consider during planning include the need for electronic review aids. These are electronic tools requested by the reviewer outside the electronic submission policy. Examples of these include book-marked, searchable versions of the integrated summaries and final clinical study reports for the core studies on CD-ROM or Microsoft Word versions of summaries that reviewers can cut and paste for their reviews. Since the preparation of the review summary can often be the longest part of the review, providing these tools can be useful in significantly reducing the total review time. 

Data that successfully meet the challenges posed in these questions can be said to exhibit certain distinctive characteristics—hallmarks, as we have called them in this document—that are indicative of data quality appropriateness, accuracy, integrity and transparency. Table 1 provides a brief overview of the hallmarks, their definitions and some general examples. As the summary table indicates, these four hallmarks of data quality are closely related and may in some cases overlap. In particular, the need for transparency in documentation and communication cuts across each of the other hallmarks. In the paragraphs that follow, we define each hallmark in greater detail and illustrate how implementation of the principles they embody can improve the quality of exposure assessments and the decisions that follow from them. 

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