A New Order of Things: Electronic Pesticide Submissions: The

Chapter 18

A New Order of Things: Electronic Pesticide Submissions: The Promise Is Efficiency

Downloaded by UNIV LAVAL on May 14, 2018 | https://pubs.acs.org Publication Date: August 1, 2002 | doi: 10.1021/bk-2002-0824.ch018

William N . Casey AVENTIS CropScience, P.O. Box 12014, Research Triangle Park, NC 27709

The key to making a successful electronic submission will depend on the ability of the industry to publish documents electronically and on paper. The electronic version must be identical to the paper copy while offering the ease of use of the WEB.

The phenomenal growth of the INTERNET has revolutionized the delivery of text and image based information. All the signs are that this will be the definitive technology for the next five years and maybe more. The rate of change in computing will pull us all forward and we may not be in the position to drive such changes but merely to follow. If you look at the pharmaceutical sector you will find that "Electronic Submissions" are already being accepted by the FDA. In the pesticide area we are currently the followers. Where does one begin? You hear acronyms like CADDY, PDF, HTML and XML, but what exactly would an electronic submission look like? How would it function? What is the basic building block of an "Electronic Submission?" The success of electronic submission will depend on the ability of the industry to publish documents electronically and on paper. The electronic

© 2002 American Chemical Society

Garner et al.; Capturing and Reporting Electronic Data ACS Symposium Series; American Chemical Society: Washington, DC, 2002.

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134 version must be identical to the paper copy while offering the ease of use of the WEB. Scanning studies is not an option. Our current way of thinking is in the direction of "How does one get one's data onto paper?" Perhaps a better way to think is "How does one get one's data into an electronic document that will have the format and appearance of paper but with a structured content?" In order to accomplish this, it will call for a significant change in the work habits of those who write reports. We must therefore initiate a new order of things. "There is nothing more difficult to


carry out, nor more doubtful of success, nor more dangerous to handle than to initiate a new order of things, " - Machiavelli, The Prince, 1532

When many of us began our careers, reports were prepared for publication using typewriters and a support staff of typists. The first change that introduced electronic capabilities for document production occurred with the introduction of word processing systems such as WANG. While this represented progress, the greatest efficiency gain did not occur until the introduction of the personal computer. With the introduction of the PC into the work place, we saw the first significant change in how reports were written. Complete control of the publication of a report now can lay solely in die hands of its author. Though some Luddites were reluctant to adopt this new technology, today a professional preparing a report on a PC is common place and almost taken for granted. New skills were required but the gain in efficiency and control over one's document led to a rapid acceptance of the PC and a shift in how businesses organized document production. While the PC offered more control and efficiency, a complete report including appendices was not always possible to produce in a word processing file. Also, the ability to share with others was limited due to compatibility problemsfromPC to PC. Even when using the same software format shifts and printing problems could occur. In other words, what appeared on the screen was not always the same as the printed copy. As a solution, the scanning of documents and the storing of each page as an unalterable image offered for the first time the ability to prepare a pesticide dossier electronically. While this method offers a reduction in the volume of paper, there is no real efficiency gain to be had with this strategy for regulatory reviewers. Also, there is no real change in how documents are produced; the thought process is still "paper first, electronic version second." Just what do reviewers want? A good example can be found in FDA's guidance to industry on electronic submissions. In their guidelines FDA indicated that documents submitted in electronic format should:


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Enable the user to easily view a clear and legible copy of the information. Enable the user to print each document page by page, as it would have been provided on paper, maintaining fonts, special orientations, table formats, and page numbers. Include a well-structured table of contents and allow the user to navigate easily through the submission. Allow the user to search and copy text and images electronically into common word processing documents.

To achieve the above goals, FDA has required that electronic documents be submitted in Portable Document Format (PDF). The pesticide regulatory agencies in North America (EPA and PRMA) have followed FDA's lead. PDFs property of capturing the exact intent of a document's design in a "final form" is critical to providing regulatory agencies with documents that can transform how one currently works with pesticide submissions. PDF enables document submitters to provide things like annotations, table of contents, bookmarks, hyperlinks within a single document and between other documents, links to supplemental files in their original form, and content searching. Critical is the ability to cut and paste information for reuse and further analysis. But the most important point is the ease of producing PDF documentsfromany application that has the ability to print, and to have as a result, an electronic version which is identical to the paper version. Both form and structure are needed in electronic pesticide dossiers and the report or study level is the initial building block. With studies in a PDF format, a dynamic submission dossier can be built containing all of the features needed to reduce effort and gain efficiencies within both the regulatory agencies and industry.

Creation of PDF Documents Where does one begin and what are the tools required to publish a study in PDF format? Actually the process can be relatively simplefromthe standpoint of a single study. The minimal tools required are: Adobe Acrobat 4.0 and a plug-in, such as, Impress from Mapsoft Computer Services Ltd. to provide document pagination. Acrobat offers several methods for converting an electronicfilefromvirtually any application to the Portable Document Format (PDF). One can use either one of two utilities to make this conversion: PDFWriter and Acrobat Distiller. PDFWriter is a printer driver that converts files directly to PDFfromany another software application. Distiller is a tool that converts PostScript files to PDF, and provides higher quality output than PDFWriter. PDFWriter is often quicker to use than Distiller. Distiller


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maintains all the formatting, graphics, and photographic images from the original document, and it provides more precise control over the conversion process than PDFWriter and would be the preferred option for complex documents. Creating PDFfilesusing Microsoft Office software is as easy as printing and bookmarks can be created automatically based on standard MS Word headings. Macros included in the Acrobat installation place a "Create Adobe PDF" as an option under the 'Tile/Print" menu of MS Word and MS Excel so that one can create PDF documents directlyfromthese applications. The basic steps in the creation of a report in PDFfileformat are as follows:


• • • • • • •

File conversionfromapplications (i.e., MS WORD MS Excel, and others) containing report components by using PDFWriter or Distiller. Assembly of PDFfilesintofinalreport. Scan signature page(s) and insert intofinalreport. Final document and table of contents pagination. Set additional bookmarks if needed (table of contents) to provide navigation. Add document reference numbers (e.g., unique report number or EPA MRID number.) Print thefinalpaper copyfromthe PDF file.

Just as one can print sections or parts of a report from different applications and assemble the report by inserting the paper pages in its appropriate place, one can also insert pages in PDF formatfromone PDF into another PDF. It is "cut and paste" at the page level. PDF can capture the exact intent of a document's design in a "final form" that is identical to the paper version. This is critical to the success of electronic pesticide submissions. The ease (simplicity) of creating a PDF from any application with the ease of printing is a very powerful feature. The construction of the different components of a study needs to be considered based on page(s) insertion and deletion capabilities of PDF. For example, different sections of a report can originatefromdifferent applications; tablesfromExcel can be combined with text sections from Word by rendering them to separate PDF files and then assembling them together into a single PDF. PDF is a file format that represents a document in a manner independent of the hardware, operating system, and the application software used to create the document. PDF was developed to allow documents to be transferred and shared across computer platforms. This capability allows one to construct a single document under one common formatfrommany different applications.Benefits of PDF Documents


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Benefits of PDF Documents


What are the advantages to the reviewer? Simply put, an increase in efficiency. A time savings can be obtained for reviewers in preparing data evaluation records due to the ability to copy and paste (drop and drag) informationfromthe PDF study directly into the reviewer's application. Acrobat 4.0 has a table/formatted text select tool that allows one to select tables and text in a PDF document and retain the originalformattingwhen the material is copied (or imported) into other applications. One can specify vertical or horizontal format, the type of text flow, and whether one wants ANSI (simple text) or Rich Text Format (RTF). • • • •

Select the table/formatted text select tool. The cursor then changes to a crosshair. Drag a rectangle to enclose the table or formatted text you want to copy. Press the right mouse button, and choose the necessary options. Drag the selected table or text to the desired application.

Being able to search the dossier for relevant information without having to manually search through several studies page by page is another benefit. Imagine being able to search a chronic toxicology study and track a single animal's reference by being able to see just the pages where the reference occurs. This is a big time savings over reviewing each page of a 2000 page report. The indexing of an entire pesticide submission is possible when using searchable PDF files. This allows full content searching across all documents in a collection. For example, one may search for a metabolite and find where it is referenced on all pages in each study of a submission. What is industry looking for as a benefit? First and most important is a reduction in time to market. Increased efficiency in report production. Longer term, libraries of studies that permit full content searching (knowledge management) reducing the time to respond to questions. Documents entering an electronic document management system would no longer have to be scanned. The same benefits for the reviewer also apply to industry scientists in being able to reuse data into a new document by being able to copy and paste formatted data regardless of platform and the application used to create the original study.


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Conclusion


Electronic study production will become a standard practice in die Agro Chemicals industry within the next 3 years. Electronic pesticide submissions are possible provided studies are constructed from the ground up based on electronic files or components. The ability to construct a complete electronic study in a "final form" identical to the paper copy is provided by PDF today. Be ready for change. New skills must be learned. IT organizations must provide support for the document production process. Andfinally,a new order of things, think PDFfirst;paper last.


A New Order of Things: Electronic Pesticide Submissions: The

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