Capturing and Reporting Electronic Data - American Chemical Society

Chapter 9 Future of Electronic Good Laboratory Practice Study Management Is Now

Downloaded by GEORGETOWN UNIV on January 7, 2018 | http://pubs.acs.org Publication Date: August 1, 2002 | doi: 10.1021/bk-2002-0824.ch009

Fate Thompson, Tommy Willard, and Carla Wells American Agricultural Services, Inc., 404 East Chatham Street, Cary, NC 27511

Advantage™ Project Management Assistance, including Advantage™ Field Trial Manager and electronic Field Trial Notebook, is a complete electronic GLP study management system. It utilizes an Access database and Visual Basic and has resources for test substances, formulations, test systems, and study management, laboratory, and field personnel. Advantage™ Project Management Assistance automates the creation of studies, trials, sample numbers and labels, and electronic field trial notebooks. The Field Trial Manager module is on CD for installation at field test facilities. Electronic Field Trial Notebooks are generated for transmission by e-mail or diskette. Trial data is received from the field by e-mail or diskette. The Project Management Assistance module automatically creates protocols, status reports and study reports in your format and word processor of choice (Word, WordPerfect, etc.). Advantage™ Project Management Assistance, Field Trial Manager and electronic Field Trial Notebook are fully validated and fully compliant with GALP and GLP regulations.

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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.

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Introduction In reviewing the preliminary Table of Contents for this ACS volume, it was noted that there were many very good topics on capturing field and laboratory data, reporting of results, and electronic submission of data. Each of these is an important component in the overall process. However, no broader view of why the agrochemical industry should consider taking an electronic approach, nor where we are going in the future was to be presented. Therefore, I talked with the editors and they graciously permitted me to write this chapter entitled The Future of Electronic GLP Study Management is Now. I ask your indulgence as I will periodically site Advantage™ Project Management Assistance software as a point of reference since it typifies key aspects of why an electronic approach is important in this industry and where we as an industry are going. As we look across the industry today, there are at least three systems involved in electronic capture of field data including Advantage™ eFTN, FieldNotes, and various Excel Spreadsheets. Among private companies there are a number of systems available for electronic capture of analytical data and systems for compiling submissions to allow for electronic submission to regulatory authorities. In addition, across the industry there are various configurations for residue databases in operation among sponsor companies. However, there is only one fully-integrated, electronic GLP study management software system in operation today. That is Advantage™ Project Management Assistance. The heart and soul of the process is not data capture or a database, but a fully-integrated management system built specifically for the study director or project manager. The study director is critical to this management process. Advantage™ has been specifically designed to aid him. As noted in Table I, we ask a tremendous amount of the study director.

Table I. Potential Study Director Management Functions • • • • • •

Bid Requests Protocol Development Sample Labels Monitor Progress Receive Field / Lab Data Query Database

• • • • • •

Contractor Payables Sample Numbers Field Trial Notebook Management Reports Final Study Report Electronic Submission


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Background Since 1987, American Agricultural Services and its Lyon, France subsidiary, European Agricultural Services have managed approximately 700 GLP studies and 8,000 GLP trials worldwide. Most of these were managed while serving as the study director. Since 1990, computer programming has been actively underway to develop a management system designed specifically to aid the study director. The driving premise has been to allow one time entry of data into a fully integrated system which operates on a database and facilitates study management thus reducing time and cost. The key development considerations that should factor into the creation of any electronic study management tool are economics, overall functionality, quality, and consideration for future requirements. Before elaborating on each of these in further detail, it is beneficial that we provide a brief overview of the functionality and capability that should reside in project management assistance software utilizing Advantage™ as an example. The Advantage™ software suite consists of two basic components. The first is Project Management Assistance. It is utilized by the study director and resides at the agrochemical company or study management company. The second component is the Field Trial Manager and electronic Field Trial Notebook that are utilized by the field research contractor and resides at his office and out in the field. A later chapter entitled Development of Advantage™ eFTN: A GLP Field Data Capture System will specifically address the functionality and capability that resides in Advantage™ Field Trial Manager and Advantage™ eFTN. The balance of this chapter will specifically address Advantage™ Project Management Assistance as a study management system which, as indicated earlier, is specifically designed for use by the study director and is the heart and soul of the study management process.

Advantage™ Project Management Assistance Advantage™ PMA is designed to function on a network such as Windows NT that allows multiple users access to the software at the same time. Alternatively, it can be installed on and used on an individual PC. The major functional components and the role that they play in the fully integrated process are outlined in Figure 1 and the chapter entitled "Development of Advantage™ eFTN: A GLP Field Data Capture System."



Figure 1. Advantage™ Project Management Assistance Software Configuration


in

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Project Manager Initial input to establish basic study design is made into this module. This includes selection or entry of study type, test substance, specific formulations, number of trials, trial locations, and determination of key study people such as the study director, field contractors, and supporting laboratories. Throughout Advantage™ PMA, a resource database is utilized which has previously been loaded with background information that can be accessed simply by point and click and does not require repeated entry. This includes, for example, name, title, address, phone, fax, e-mail, etc., for study director and key field research contractor or laboratory personnel. By entering the study type, Advantage™ recognizes the basic requirements for a crop residue versus a soil dissipation or groundwater or exposure study and automatically sets up files in the database to anticipate and to receive the type of data to be generated.

Protocol Generator Once certain relevant information has been entered into the Project Manger module (as well as the Sample Number Label Generator and Field Trial Notebook Generator), the study protocol can be generated electronically. By establishing a protocol format of your design and utilizing the functionality within the protocol generator, the study protocol with complete text and tables can be generated in one to two minutes simply at the push of a button. The protocol is available to you in your own word processing software and both the format as well as thefinisheddocument can be created and edited by the user without additional programming inputfromAmerican Ag.

Sample Number Label Generator As this is a fully integrated system, certain input that has previously been made into the Project Manager module is automatically received into the Sample Number Label Generator. The user is then able to define, for example, number of treatments, plots, sub-plots, number of replications, and determine specific sampling events, i.e., as for a harvest study versus a decline study. This module then generates sample numbers for the entire study, trial by trial, which can then be exported into a LIMS system. Alternatively, sample numbers can be imported from a LIMS system rather than being generated within Advantage™. A sample list is generated which can be printed at anytime. In addition, sample labels are generated which can be printed with all of the information needed to clearly describe that sample with the single


59 exception of the sampling date which is not known until the actual sampling event occurs in the field. These sample labels can be generated to contain any one of several bar code systems. These sample numbers alsoflowautomatically into the Field Trial Notebook Generator.


Field Trial Notebook Generator As input is made logically and sequentially into each of the previous modules, relevant information electronically flows into the Field Trial Notebook Generator in preparation for creation of specific field trial notebooks. Within the Field Trial Notebook Generator, another layer of detailed information is entered including, for example, application details of rate, timing, number of applications, method of application, etc. Advantage™ automatically creates or builds the electronic Field Trial Notebook by selecting the specific forms or pages which will be required for a crop residue, soil dissipation, groundwater, exposure study, etc., based on the study type that was indicated previously in the Project Manager module. All information that is known about that specific trial is automatically transferred from Advantage™ into each field trial notebook. The electronic Field Trial Notebook can then be sent by e-mail or diskette to the Advantage™ Field Trial Manager module that resides at the field research contractor's location. Advantage™ also automatically prepares the database to receive field biology data when it is emailed from the field research contractor back to the study director. Sample Tracking and Analytical Results Reporting The STARR module resides at the analytical laboratory whether it is internal to the sponsor company or is a contract laboratory. When samples are received at the analytical laboratory, barcode readers are used to acknowledge receipt of the sample and STARR automatically registers all information contained on the sample label to include the date of receipt of the sample. In addition, condition of the sample can easily be entered into the system and sample location can be easily specified. By using a barcode reader system as the sample moves from preparation to extraction to analysis to reporting, STARR automatically tracks sample movement throughout the laboratory facility. Having identified and tracked the sample electronically, STARR facilitates the summarization of analytical data into afinalstudy report.


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Project Management Assistance Database The database that is resident within Advantage™, or the sponsor company database to which Advantage™ is linked, is a key to the overall functionality of this fully electronic, fully integrated system. Information from each of the previous modules and from the data collection in the electronic Field Trial Notebook or STARR in the analytical laboratory is continually accruing into the database. Typically, Advantage™ is interfaced directly to the sponsor's database. Alternatively, it can operate with its separate internal database. Based on the functionality of the Document Generator that is inherent in Advantage™ and the linkage of Advantage™ with the sponsor company's database, any number of reports of the sponsor company's design can be readily generated. Typical examples are outlined below.

Final Study Report Recognizing that each sponsor company has unique study report formats and recognizing that the sponsor companies want the flexibility to internally modify their report formats, Advantage™ has been designed such that reports are generated in the report template or format designed and preferred by each individual sponsor company. This includes development of both text and tables as well as creation of the report in the word processing software preferred by the sponsor company. Since it is generated in a word processing format, the study director can easily edit the document. This process is fully automated such that having selected the study of choice and a previously designed report template, pressing a button allows drafting of the complete study report in a couple of minutes.

Bid Document The same Document Generator functionality that was utilized to create protocols and final study reports can be utilized to create bid documents to secure quotationsfromsubcontractors. As indicated previously, the format is of the sponsor company's own design including tables with key technical parameters and any supporting text. Relevant information that has been previously entered into Advantage™ when creating the study design can readily be pulled from the database to create the bid document. Once the bid document is created specific to that study or specific to that individual field


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trial, it can be sent by e-mail to the subcontractor. After the subcontractor enters cost and other relevant information into the document, it can be returned by e-mail back to the study director and the information integrated into Advantage™.


Payables Sponsor companies have clearly indicated the desire to have the ability to monitor payables for contracted or in-house projects without being dependent upon in-house accounting systems. The Payables Module within Advantage™ accomplishes this by tracking by study and by trial the contract amount, when payments are due, specific amount of each payment, the total amount invoiced, the amount paid, the amount remaining to be paid, etc. Based on sponsor company preference, this can be run independently of company accounting systems and / or can be linked directly to sponsor company accounting systems.

Development Considerations Economics A key consideration in the development of Advantage™ software was to maximize study management efficiency resulting in reduced time requirements and significant cost savings. It was noted previously that utilizing individual PCs and paper field trial notebooks required considerable repetitive entry of the same information. The end result was that 80% of the study director's time was devoted to largely clerical activities. This was because development of the protocol, field trial notebook, status reports, study reports, etc., were stand alone activities that were not integrated. As noted previously, the operating premise behind Advantage™ was a single entry of information into a fully integrated system such that all components are linked and any information entered into one component automatically flows into downstream components. This immediately refocuses the utilization of the study director's time from largely clerical to largely technical management and decision making functions — which is the intent for this critical position. From American Ag's in-house experience, this transition from largely paper systems to fully integrated electronics systems with Advantage™ have resulted in up to an 80% increase in efficiency in study management time. As a bonus, and as part of the intentional design, the complete study data now resides in a readily-accessible electronic database rather than sitting in a file cabinet on paper. This improved manpower utilization allows resources to


62 be refocused toward improving the science, responding to internal and regulatory data requests, reducing overtime and submitting registrations on time allowing quicker entry into the market.


Functionality The basic functionality consideration driving the development of Advantage™ was to mechanize and fully integrate all study management functions. As noted earlier, input of data one time was a key consideration. This was accomplished by developing resource databases that reside in Advantage™ Project Management Assistance and allow a myriad of information to be pulled into any given study simply by pointing and clicking on the relevant resource database. This includes items such as a list of all possible study directors and their address, phone, fax, e-mail, etc., as well as complete lists of all subcontractors and their contact information. Also included are lists of all sponsor company active ingredients and including all the supporting technical parameters for each. Having entered this information into Advantage™ one time, it is available without any retyping by simply pointing and clicking on this information. Once it is pulled into the specific study of interest, it automatically populates the datafieldswhere that particular piece of information should go from development of the protocol through management of the study into development of the final study report. User-friendly screens incorporated into Advantage™ give it a very familiar look. The design and functionality have a Windows look and feel. A tab layout is utilized to allow easy selection of the module within which one wishes to work, as well as the functionality within a module. This tab layout has the feel of chapters within a book, allowing the user to know exactly where he is and where he needs to look for a desired module or functionality. Movement backward or forward is a simple keystroke command. Pull down menus are integrated throughout the software that allow the user to tap directly into the resource databases to incorporate information by point and click rather than retyping. For example, all of the RAC test systems as defined by EPA and OECD, such as corn, citrus, coffee, etc., are readily available in pull down menus. Selecting the test system from the pull down menu also automatically identifies the standard sample fractions and places those in the appropriate location throughout the Advantage™ software. Button commands are incorporated throughout the software to allow use of a single keystroke to select pre-programmed capabilities such as switchingfromEnglish units to metric units, cloning a study, generating afinalstudy report, etc.


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As the user navigates Advantage™, it is clearly apparent that it has been designed for an understandable yet flexible workflow. By simple point and click, the user can readily maneuver back and forth among the modules that have been previously described without being locked into a rigid sequence of events. Drill down capability allows the user to progress logicallyfromproject into individual study within a much larger project and into specific trials within a study. Within a trial, this same logical drill down sequence allows progression from general information into detailed treatment information and further into very detailed sample information, if desired.

Quality GLP and GALP compliance as well as proper software validation are two of the factors that define quality in any computer software. Key compliance features incorporated into Advantage™ include requirement for a user name and assignment and entry of a secure password in order to access the Advantage™ software system. In addition, security levels can be assigned by the systems administrator that define the access level of the user as administrator, enter / edit, view only, and no access. In addition, these security levels can be assigned for each specific software module inherent in the Advantage™ system. Once any information is entered into Advantage™ and is saved, any change of this information requires creation of a Data Revision Record that indicates the field of information which is to be changed, the previous information, the new information, and the reason for this change. Also, automatically recorded are the user's name and the date and time at which this change occurred, as well as entry of the user's secure password. Proper software validation is an integral part of any software development project. Validation at both a developer level and a user level will be discussed in much more depth in later chapters. In developing Advantage™, American Ag followed standard industry validation and documentation practices for development SOPs, a thorough and well-documented software development life cycle, authorization for commencement and completion of all development milestones, user requirements, system design specifications, functional design specifications, system integration testing, and validation testing. Since American Ag is a GLP study management firm, we have also validated Advantage™ in its entirety within our study management facility as a user. We leave user system validation by sponsor companies to their discretion, but are available to support and assist them as they may require. In addition, American Ag has and will continue to fully support vendor audits as required and requested by sponsor companies who license Advantage™.


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Future Requirements From its inception, Advantage™ Project Management Assistance software has been designed to allow for increasedfiinctionalityand interfaces as they are developed in the future. These considerations for future requirements should be part of any decision on GLP study management tools. These include the development of a modular system that allows use of all or only certain parts of Advantage™ and the integration of these functional components with existing in-house capability. It has been designed on a database platform for increased functionality allowing ease of drill down to more and more detailed information, as appropriate. This also facilitates the ability to query datafromthe database and to interact with other databases. Development is currently underway on a Document Generator module within Advantage™. This incorporates the flexible report template design and the speed and ease of report writing noted previously with the ability to easily mine datafromvirtually any database. The web basing of Advantage™, noted below, renders its operation database independent allowing complete compatibility with Oracle, SQLServer, etc., databases. Current operation is on network operating systems such as Windows NT, which is by design a universal system. Building Advantage™ as a networkenabled system allows the user to install it on and integrate it directly into an existing network. Last, but certainly not least, from its inception Advantage™ has been designed and structured with web basing in mind. We believe that this technology holds great promise for the agrochemical industry. This enables users access to Advantage™ any time from any computer anywhere in the world. Agrochemical companies can then globalize their operations by linking all their facilities and sub-contractors on a single web-based system. By early 2001, Advantage™ Project Management Assistance will be web based. Development of the web based Advantage™ eFTN will occur later in 2001.

Summary Electronic study management in a fully integrated system, such as Advantage™, affords major time and cost savings. Whereas electronic data capture at the field and laboratory level are important, they are of limited consequence unless the efficiency gained from full integration can be established from data capture to final reporting and, potentially, electronic


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submission. This in turn translates directly into earlier regulatory submissions, faster response time to regulator's questions, earlier registration approvals, and quicker entry into the market. Electronic study management is the nexus of data inputs and outputs. Therefore, the maximum benefit to the study director, and in turn to the agrochemical industry, is obtained when it is a considered dimension of your decisions as they relate to the complete gamut of field data capture, summary analytical data capture, residue database output, and regulatory submission requirements.


Capturing and Reporting Electronic Data - American Chemical Society

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