Development of Advantageâ¢ eFTN: A Good Laboratory Practice Field

Chapter 4

Downloaded by EAST CAROLINA UNIV on December 29, 2017 | http://pubs.acs.org Publication Date: August 1, 2002 | doi: 10.1021/bk-2002-0824.ch004

Development of Advantage™ eFTN: A Good Laboratory Practice Field Data Capture System Ron Thompson, Ted Paczek, and Dudley Dabbs American Agricultural Services, Inc., 405 East Chatham Street, Cary, NC 27511

Development of Advantage™ electronic Field Trial Notebook (eFTN) as an easy-to-use and cost-effective GLP field data capture system was driven by the need for manipulation of residue data electronically, favorable user economics, ease of use, GLP compliance, and ease of validation. Both companies and regulators need GLP field data in a database that can be queried. Favorable user economics was addressed by Advantage™ eFTN being free to field researchers. Establishing Advantage™ eFTN as a form-driven system and providing flexibility to move Advantage™ eFTN from one computer to another established ease of use. GLP compliance was addressed by requiring unique passwords and time and date stamps for entering the notebook and saving information, the automatic requirement for data revision records for any data changes, and providing multiple security levels. Self-documenting software validation testing insured ease of validation by the field researcher and facilitated compliance acceptance.

© 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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Introduction Just a few years ago, it would have been accurate to say that electronic data capture for GLP (Good Laboratory Practice) field trials will happen. Today, however, a much more accurate statement would be that electronic capture of GLP field data is happening. While less than 5% of GLP field trials in the US in 1998 were conducted using electronic data capture, as notai in the following statement, that had increased substantially by 1999 and continues to increase. "20% of our GLP trials in 1999 ware conducted using electronic data capture... we want it, our guys like it, we want it to go that way... it standardizes the notebook (among sponsors) in a way that paper field trial notebooks never accomplished," indicated Mick Quails, Director of Research, Quails Agricultural Lab in Ephrata, Washington, at the 1999 meeting of the Society of Quality Assurance. To understand why this increase in electronic capture of GLP field data occurred so rapidly, it is beneficial to understand the key factors that motivate agrochemical companies to consider electronic study management systems including electronic data capture. This interest in electronics at the sponsor company level is driven primarily by the need for a queryable database and economics. Both EPA and OECD regulators are being inundated with paper to the point that physical storage and handling of paper study reports and submissions is becoming a major burden. In addition, searching and retrieving data from paper systems is inordinately slow and cumbersome. Electronic submissions, which the regulators are openly embracing, are greatly facilitated by having study reports and supporting raw data in an easily accessible format. It is much easier to accomplish this if the studies were managed utilizing electronic study management tools that include electronic data capture and the data are contained in a database that allows the flexibility of electronic reporting. The second factor that motivates agrochemical companies to consider electronics is simple economics. Agrochemical companies continue to consolidate because the market is maturing such that it can no longer afford a large number of companies and duplication of time and cost. For example, what we recognize today as Aventis Crop Science is composed of a conglomerate of companies that includes what earlier was Hoechst, Schering, Noram, Agrevo, Rhone-Poulene, Rhodia, Union Carbide, Mobil, VirginiaCarolina, and Amchem. In a similar manner, Syngenta is an aggregation of Novartis and Zeneca each of which, like Aventis, represented quite a list of previous agchem companies that have been consolidated under one management.


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In short, the agrochemical industry is asking its internal staff and its subcontractors to continually produce increased results with fewer resources. The challenge to the agchem industry is to find ways to do that easily and cost effectively. Electronic GLP study management and electronic field and laboratory data capture systems are part of the answer.


Advantage™ Field Trial Manager and eFTN Functionality For purposes of this paper, it is important to understand the principals of electronic GLP study management as discussed in another chapter in this volume entitled "The Future of Electronic GLP Study Management is Now". The functionality of Advantage™ Field Trial Manager and electronic Field Trial Notebook as outlined in Figure 1 and as described in the following text are integral parts of Advantage™ Project Management Assistance (PMA). Integrated Components Field trial notebooks that have been generated in Advantage™ PMA are emailed directly from Advantage™ PMA into the second Advantage™ software component, which is Field Trial Manager. Alternatively, Advantage™ electronic Field Trial Notebooks can be mailed to the field researcher by diskette and loaded directly into Advantage™ Field Trial Manager. Sample labels that have been generated in Advantage™ PMA and include critical sample information and bar codes are shipped directly to the field research contractor. Periodically during thefieldtrial, thefieldresearcher can e-mail the Advantage™ eFTNs back to the study director to provide trial updates. At the end of the trial, the completed electronic field trial notebook can be returned to the study director by e-mail or diskette.

Advantage™ Field Trial Manager The Advantage™ Field Trial Manager software resides at the field researcher's office on either a stand-alone computer or on a server within his local area network. The Field Trial Manager performs several functions for the field researcher including receiving the field trial notebooks from the study director in electronic format and keeping each notebook separate such that it receives and sends out only the data related to that specific field trial and associated electronic Field Trial Notebook.



Figure 1. Advantage™ Project Management Assistance and eFTN.


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22 Many field researchers keep their facility records, such as, weather data, field histories, and chemical receipt and storage, using Excel spreadsheets. Advantage™ was intentionally designed so that existing facility records in Excel, etc., formats could be imported directly into Advantage™ in an electronic format. The field researcher does not have to change his current systems or purchase and learn additional software. User experience suggests that the ability to electronically import facility records saves substantial time over paperfieldtrial notebooks. In addition, Advantage™ Field Trial Manager is designed such that the field researcher can draw plot maps in virtually any existing software program and, again, import these directly into Advantage™. This allows the researcher to bring the plot maps into Advantage™ eFTN electronically and avoid the need to learn additional software programs. Typical drawing programs that Advantage™ accommodates include Excel, Power Point, FreeLance Graphics, various CAD systems and Microsoft Paint. Tremendouslyflexibleprint capabilities are incorporated into Field Trial Manager. These enable the field researcher to print any page of the notebook or all pages of the notebook at any time. eFTN Field Data Collection Advantage™ eFTN offers by fer the most flexibility in the industry in terms of capturing field data. When operating in a completely electronic data capture mode, electronic field trial notebooks can be "checked-out" of Field Trial Manager by copying them to a diskette and, in turn, loading the diskette onto a laptop computer that can be taken directly into the field for direct electronic data entry. Upon completion of the field data collection activity, this process can be reversed by copying the electronic field trial notebook to a diskette and using the "check-in"fimctionto move it back into the Field Trial Manager. Only one "live" copy of the notebook exists at any one time since the notebook 'folder' in Field Trial Manager is locked while it is "checked-out". This prevents the possibility of simultaneous or duplicate entries into eFTN. Alternatively, most of the eFTN can be completed at the field researcher's office. The print options within Advantage™ Field Trial Manager then allow printing only critical application and sampling pages and taking these pages directly into the field for capture of these critical data on paper. Or, the entire field trial notebook can be printed out and all entries made on paper wherein paper will be the raw data. These data can be subsequently transcribed into the Field Trial Notebook with the retention of paper as the raw data and use of the electronic copy to facilitate data movement.


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Development Considerations


Development of Advantage™ electronic Field Trial Notebook as an easyto-use and cost-effective GLP field data capture system was driven by the need for favorable user economics, ease of use, GLP compliance and ease of validation at the user level. Each of these will be discussed in greater detail below.

Favorable User Economics Whereas the field research contractor does, and will increasingly in the future, receive some benefits in time and cost savings from using electronic field data capture, the vast majority of the accrued benefits of using electronics occur at the agrochemical sponsor company level. In order for the sponsor companies to receive these benefits and in order for the field research contractor to readily embrace electronic field data capture, American Ag felt that it was imperative that cost to thefieldresearcher for Advantage™ software be kept to a minimum. Therefore, Advantage™ Field Trial Manager and electronic Field Trial Notebook are provided to field research contractors at no cost, thus eliminating cost as a barrier to market entry and user acceptance. As will be noted under "Ease of Use" below, Advantage™ was designed to be intuitive so that little or no training is required thus eliminating time and cost of training as another potential economic hurdle. By contrast, the typical license for each individual computer for FieldNotes™ is $6,000 plus a mandatory annual support fee of $600 per license / computer. In addition, the degree of difficulty in understanding the design and functionality of the FieldNotes software is such that one or more training sessions are required, for which thefieldresearcher must pay a fee plus time and travel

Ease of Use American Ag recognized clearly that the field researchers in this industry are excellent field biologists but not computer experts. Therefore, a major development consideration was that Advantage™ eFTN look and feel like a paper field trial notebook. As an indication of our success in accomplishing this, note the following quote from John Corkins, President of Research feeHire in Porterville, California. "Our Principal Field Investigators tell me that if you can use the American Ag paper notebook, you can use the Advantage™



24 eFTN. Because of this, we don't foresee any additional costs as a result of using Advantage™/' Advantage™ eFTN was designed as a form-driven software program. That is to say, it has the lode and feel of a book or of the paper field trial notebook with which field research contractors are already familiar. As the user enters the program, a form appears with sequential tab headings that look like, and function like, the chapters in a book. For example, depending on the trial type, the following headings may appear: General Information, Supporting Forms, Spray Application, Plant Sampling, Storage / Shipping, and Weather Data. At a glance, the user can see the content and functionality of the Advantage™ eFTN chapter after chapter after chapter. Clicking on the chapter heading opens that chapter or section of eFTN and reveals a list of forms or pages with descriptors that reflect the functionality contained on that page. In that regard it looks and feels very much like a book allowing movement easily from chapter to chapter and then page to page within a chapter. This ability to move chapter to chapter and page to page, either forward or backward, is a reflection of the ease of use and flexibility built into Advantage™ eFTN. The user can always readily see where he is and where he wants to go. Additional flexibility features include the feet that not all information that is requested on a given form has to be included before the user can save existing information and leave that form. Similar flexibility was mentioned earlier with regard to printing wherein any page or all pages of the field trial notebook can be printed at any time prior, during, or after having entered relevant information. Another very beneficial flexibility aspect of Advantage™ is the feet that it can be moved from one computer to another without cumbersome restrictions of licensing being tied to one individual computer as is true for FieldNotes. A user-friendly aspect of the form driven approach is that a form such as "Spray Equipment Description and Calibration" displays on one page all of the logical information associated with describing the sprayer and necessary settings. Also included is a logical sequence of collection and display of information on calibration to allow automatic electronic calculation of the actual spray rate and volume.

GLP and GALP Compliance One of the cornerstones of GLP and GALP (Good Automated Laboratory Practice) compliance is that a reviewer be able to recreate what has occurred within a study. More specifically, the reviewer needs to be able to easily determine who did what and when and be able to clearly determine if any changes were made to the original data. Security of the system and the



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resulting compliance were addressed by requiring a user name and unique password in order to enter Advantage™ Field Trial Manager and, individually, each Advantage™ eFTN. Passwords should be known only to the user and the system administrator and are secure as long as the user and system administrator guard the confidentiality of this information. Advantage™ contains the capability to assign various security levels for the different individuals who will be using the Field Trial Manager and eFTN. These include a system administrator who has complete access to the system, to add and change user passwords, etc. Additional security levels include "view / edit", which allow field researchers to add, change, and view existing information within the field trial notebook. In addition, view only" security levels are included for personnel such as quality assurance allowing them to use their user name and password to enter the notebook and view existing data, but does not allow them to add, delete, or change any information. All activities within the Advantage™ eFTN automatically carry a date and time stamp. Any activity within the Advantage™ eFTN that involves inputting information or changing information automatically inputs a date and time stamp when any information is saved into the system. A Data Revision Record is provided as part of GLP compliance and to facilitate quality assurance auditing of the field trial notebook. Once data have been entered into the notebook and saved, any attempt to change these data triggers the requirement for a Data Revision Record. If any change of the data is attempted, a form will appear on the screen identifying the data field that is to be changed. It will display the original value and require entry of the new value with an indication of why the data are being changed. In addition, saving this change requires entry of the user name, the unique password, and automatic notation of the date and time at which the data are being changed. This complete Data Revision Record, or any part of it, are available electronically or by printing. As a further security and compliance measure, Advantage™ contains an automatic proprietary encryption and compression process such that eFTNs sent to or receivedfromfieldresearch contractors by either e-mail or diskette can only be read by Advantage™. Included in this process is the ability to prevent field trial data of one sponsor companyfrombeing read by another and information in one eFTNfrombeing read into the incorrect file. Consideration has also been given to archiving requirements for raw data and copies of raw data generated by Advantage™ eFTN. When thefieldtrial is complete, the field researcher uses the "send-to-sponsor" function in Advantage™ Field Trial Manager to email the notebook to the sponsor. This is considered the raw data and can, and should, be archived by the sponsor. In addition, for his own records, the field researcher may also want to archive a copy of the field trial notebook. Both the sponsor and the field researcher can tÈ


26 archive electronically in any electronic medium they choose, i.e. hard drive, tape, disc, CD, etc., which prevents deterioration. American Ag maintains software that can read the eFTN regardless of version. Alternatively, the sponsor and field researcher can print the notebook in its entirety, sign, date, and archive it as a hard copy.


User Validation Software validation can occur at several levels. American Ag has conducted extensive validation of Advantage™ software as the software developer. (See the chapter entitled "The Future of Electronic GLP Study Management is Now '.) In addition, sponsor companies who license Advantage™ have validated Advantage™ Project Management Assistance and Advantage™ Field Trial Manga* and eFTN as the licensee of this software technology. It can be argued that software can only be validated in the specific environment in which it is being used. Therefore, part of the compliance considerationft>rAdvantage™ Field Trial Manager and eFTN included a comprehensive validation plan containing self-documenting software validation testing to ensure ease of validation by thefieldresearcher. An easy-to-use validation notebook is provided at no cost to each field researcher that receives Advantage™. This allows him to do a complete user validation on each computer and with each printer, etc. that is utilized in his use environment in collecting and reporting field data. It is comprehensive in that it occurs on the computer system at the point of data collection. Although comprehensive, it is a vary easy to use system such that validation of the first computer requires two hours or less and, based on a logical learning curve, requires one hour or less for each additional computer. The validation is comprehensive in that every functional aspect of the notebook is validated according to a validation test script. Documentation is provided to verify, for example, calculations, print integrity, security features, etc. including receipt and return of a field trial notebook sent by e-mailfromAdvantage™ Project Management Assistance. Reports are then automatically generated from the validation test script to confirm a summary of validation activities and notation of any exceptions that may have occurred. 5

Conclusion The need for a queryable database and to obtain increased results with fewer resources has and will continue to drive the acceptance of electronic field


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data capture. The development of Advantage™ electronic Field Trial Notebook as an easy-to-use and cost-effective GLP field data capture system was implemented and completed with these needs in mind. These aspects plus GLP compliance and ease of validation are the hallmarks of Advantage™ Field Trial Manager and electronic Field Trial Notebook. This software, complemented by Advantage™ Project Management Assistance, comprises the most comprehensive and user-friendly study management software available in the industry today.


Development of Advantageâ¢ eFTN: A Good Laboratory Practice Field

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