Capturing and Reporting Electronic Data - American Chemical Society

Chapter 6 Electronic Field Data Perspective 1,2

Kenneth A. Ludwig

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and Robert Hoag

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Downloaded by SUFFOLK UNIV on January 19, 2018 | http://pubs.acs.org Publication Date: August 1, 2002 | doi: 10.1021/bk-2002-0824.ch006

Bayer Corporation, Agriculture Division, Bayer Research Park, 17745 South Metcalf, Stilwell, KS 66085-9104 Current Address:1611Padock Drive, Kearney, MO 64060-8423 2

The Agriculture Division of Bayer Corporation has been using the Astrix FieldNotes™ electronic field notebook in field residue studies since 1997. During 1997 it was used for all field residue trials conducted on Bayer research farms. Beginning in 1998, it has been used for all Bayerfieldresidue trials. Bayer uses Astrix LabNotes™ to managefieldresidue trial samples in the laboratory. In addition, Bayer uses a spreadsheet and word processor to create study protocols, bid forms and work agreements. A spreadsheet is used to facilitate management of the field trials. All of this electronic information is kept on the Bayer network where Bayer employees may readily access it. Information transmission is done on the network within Bayer and via the Internet with contractors. Electronic systems have been important tools that have given Bayer the ability to substantially increase the number of residue studies conducted each year.

Introduction Electronic capture of field trial data seems to be developing more slowly than electronic capture of laboratory data and field performance data. This may

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© 2002 American Chemical Society

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


35 be, in part, because GLP (Good Laboratory Practice) requirements do not apply to performance research. Major differences among performance, magnitude of residue and ecological effects trials, resulting in relatively small markets for electronic applications are probably major factors. This chapter concentrates on the experience of Bayer Corporation with electronic capture offieldresidue trial data. However, much of what is said about residue trial data applies equally to performance data. Major characteristics of field residue and performance trials are given. Advantages and disadvantages of electronic field trial data capture for study sponsors and field investigators are briefly discussed. The chapter concludes with some speculation on thefixtureof electronicfieldtrial data capture.

Field Residue Studies and Performance Trials For those who may not be familiar with these types of studies, here are some major characteristics. Field residue studies are required by US EPA for registration of pesticides. The purpose of the studies is to set the limits of use, that is, define the maximum use pattern: the maximum rate, number of applications, interval between applications and PHI (Pre-Harvest Interval). Three to 20 trials are required per crop, depending upon the acreage grown and the importance of the crop commodities as human food. It is very common for registrants to use the crop group approach for registrations. Representative crops in a crop group are tested and the registrant gets a registration for all crops in the group. GLP and GALP (Good Automated Laboratory Practice) standards apply to these studies. Major registrants, such as Bayer Corporation, conduct as many residue trials as possible on their own research farms and contract the remainder to independent research companies which range in size from those that may have several research farms to husband and wife teams with only one site under their control. EPA does not require submission offieldperformance trial data and GLP standards do not apply to these trials. Performance trials are conducted to determine the use pattern required for effective performance. Much effort goes into determining the minimum effective rate. Usually, about 30 trials are required per major pest. Much of Bayer's performance work is done on our own research farms or by our Field Development Representatives. Contractors are used for crops and pests we cannot handle internally. The differences between residue and performance trials, as well as the GLP requirement for residue trials, make it difficult to design an electronic system that can handle both types well.


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Advantages and Disadvantages of Electronic Data Capture for Study Sponsors The advantages of electronic field data capture are prompting sponsors to adopt electronic systems. Electronic checking offieldreports for completeness and the elimination of the need to check calculations yield major time savings. Electronic data summarization for inclusion in the final study report is also a major time saver. These major increases in efficiency not only save money, they may allow a submission for registration to be made sooner. Smaller, but significant, savings are achieved by electronic transmission of data, including study protocols, initial andfinalfieldreports, and status updates. Generation of field report files is speeded by cloning of the initial file and automated entry of sequential trial numbers. Electronic systems are also very efficient for management offieldtrials. Bayer uses a spreadsheet to facilitate contracting tests, ordering test substances and payment of invoices. There are also disadvantages to electronic systems. The cost of a commercialfieldtrial data system is significant and multiple copies are needed. The cost for a sponsor to develop a unique system of its own would be even greater, and, the sponsor may not have qualifiai personnel. There are costs for system validation and testing, development and maintenance of standard operating procedures, and training. Possible additional costs include information system hardware and software and operating system upgrades.

Advantages and Disadvantages of Electronic Data Capture for Contract Researchers Advantages for contract researchers are generally considered to be less than for sponsors, but there are significant advantages. Electronic checking for completion is instant. Linkage, entering a given bit of information only once with instant copying to every other location where that information is needed in the report, saves substantial entry and checking time. And, it eliminates a substantial source offrustrationcommon with many paper reports. Electronic transmission of data from and to the sponsor is just as effective for the contractor as it is for the sponsor. Generation of progress report files for electronic transmission to the sponsor eliminates many phone calls and completing and faxing paper forms. Use of spreadsheets to manage trial work is convenient and effective. Electronic logs can be used to generate paper records for sponsors still using paper forms. Having a system required by a


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sponsor means a contractor can work for that sponsor. Some years, there may be a substantial amount of work. The cost of an electronicfieldreport system is the major disadvantage for contract researchers. A computer suitable for field use is required. For larger contract firms, multiple copies of the system, multiple field computers and a network may be necessary. Personnel must be trained. As with any new computer application, proficiency comes only with practice. Frustration of learning the application and its "quirks" replacesfrustrationof entering the same data in multiple places on paper forms. Not having a system means a contractor cannot get workfroma sponsor that requires it

Bayer Experience with Electronic Capture of Field Data We believe our experience can serve as an example of what is necessary to implement use of an electronic field data capture system. Bayer Corporation has been upgrading the quality our field residue studies since 1994. We implemented the new study guidelines in 1995; a year before required by the US EPA. We established a group to evaluate our methods and ways to improve them. The group determined that our paperfieldreport system was the biggest problem we had. The group considered making major improvements in our paper report system versus an electronic system. The advantages of an electronic field report system made that the best theoretical solution. However, there was no commercial system available. We were starting to consider developing a system ourselves and possibly marketing it for use by other sponsors when Astrix Software Technology called about their new system called FieldNotes™. We arranged a demonstration of the system and we liked what we saw. We were especially impressed that an experienced field residue study director and field investigator, who also had knowledge of computer system development, was the key member of the development team. Our experience developing our own electronic performance data capture systems had shown us the importance of someone with this dual experience. After the demonstration, we consulted our toxicology group about development and validation of GLP data systems. These discussions confirmed our conclusion that we did not want to develop a system ourselves. Therefore, we arranged an in-depth demonstration of FieldNotes™ and included our upper research management. We did a vendor audit of Astrix. The audit team comprised our quality assurance supervisor, our information services representative and myself. We looked at system development, change and defect correction procedures and documentation. We also discussed our concern that Astrix was a relatively


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small company that could "go away tomorrow; leaving us with what is sometimes called "vaporware." Astrix provided their standard lease agreement, which stipulates that in the event that Astrix cannot support the software in the manner specified in the agreement, Bayer would get the system code for the purpose of maintaining a useable system. We then recommended the implementation of FieldNotes™ as our electronic field residue trial report system. Our recommendation report included a thorough cost/benefit analysis. Management approved implementation. Multiple copies of FieldNotes™ were leased; for our study directors, research farms, sample receipt and processing group, and field coordinator. We planned limited testing of FieldNotes™ against paper forms during the fell of 1996, but the pen computers we ordered arrived very late. Despite this setback, we decided to go ahead and implement use of FieldNotes™ on the seven Bayer research farms for our 1997 residue program. There were problems with the pen computers. They were too slow (486) and our farm personnel had problems with the effectiveness of the handwriting recognition program. Astrix provided excellent support and we got through the season without losing a single trial due to FieldNotes™, computers or handwriting recognition. For the 1997 and 1998 residue programs, Bayer used study management companies because management removed responsibility for conducting and contracting field residue trialsfromour Field Development Representatives. It was thought that this additional responsibility would be too much for our one field coordinator (the author). All 1998 field residue trials were conducted with FieldNotes™. We encouraged contract researchers to acquire the system and many did. We were able to locate all trials with contractors using the system. During 1998, EPA visited Bayer Research Park at Stilwell, Kansas. EPA audited one completed residue study and an application in a trial being conducted using FieldNotes™. There were nofindingswith respect to the use ofFieldNotes™. All 1999 residue trials were conducted with FieldNotes™. Additional contract researchers acquired the system. There is now a more than adequate number and distribution of contractors using the system to allow us to conduct trials on any crop grown in the United States and Canada. During 1999, Bayer implemented use of a spreadsheet to facilitate management of field residue trials. We discontinued use of study management companies for the 1999 residue program. Through efficiency gains due to use of electronic data capture and trial management systems, we were now doing almost twice as many trials as we had ever done before, and, we were doing them at a lower cost per trial. Prior to and during 1994, we had been conducting 50 - 75 residue trials per year. During 1995 through 1998, we conducted 150 - 175 trials per year.



39 During 1999 we conducted approximately 300 trials. The Bayer residue program for 2000 is now in progress and we are conducting approximately 900 trials. This number of trials has required a great deal of extra effortfromall Bayer employees involved with conducting and supporting the residue program. We've given that effort and we are succeeding, but this level of success would not be possible without use of our electronic data collection and trial management systems. We are achieving the expected time savings in data checking and summarization. Last year, after one of our study directors had completed the final study report on his first residue study conducted entirely using FieldNotes™, he called me. This is an approximate quote: "Ken, you know I had my doubts about FieldNotes™, whether or not we would really save much time. Well, now Fm a believer. I just did in two hours what used to take two weeks." Of course, there have been some problems. The primary problem has been missing data. We have always had problems with missing data in residue field reports. Some of these continued after implementation of our electronic systems. However, now FieldNotes™ has completion indicators on the table of contents form buttons. And, we have implemented a new policy for contractors. All electronic notebooks will be checked for completeness and will be complete before final payment is authorized.

Speculation on the Future Even though we have solved many problems and made what I consider spectacular progress in just a few years, I believe we are just getting started with electronicfielddata collection. Further improvements will be coming and they will come fast. Improved importation of data from other electronic data systems has already started. FieldNotes™ imports weather data from a spreadsheet. Bayer is modifying its electronic performance data collection system to be able to import data from the commonly used commercial performance data systems. Data transmission over the Internet is improving and is already far superior to regular mail and even next day delivery services. There will be smaller, more rugged, and easier to use field computers. There will be headsets with tiny screens just in front of your eye so that the form image appears tofloatin space before you. The entire computer will be in a small headset. We will talk to the computer. It will seem to carry on an intelligent conversation about our experiments. Field scientists will feel like Captain Kirk. "Beam me up Scotty."


Capturing and Reporting Electronic Data - American Chemical Society

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