Realizing the Promise of Electronic Data Capture A Practical Guide

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1 Realizig the Promise of Electroic Data Capture A Practical Guide INTRODUCTION The promise of icreased efficiecies stemmig from electroic data capture ad electroic data maagemet (referred to here collectively as EDC) has existed for years. However, adoptio of EDC as a stadard cliical trial tool has bee slower tha expected, primarily because of the mixed track record for EDC implemetatios. Accordig to the most recet bechmarkig documet from The EDC Forum, 70% of EDC iitiatives fail to achieve expected beefits. 1 The full potetial of EDC has yet to be realized by the majority of cliical developmet orgaizatios. Ay cliical developmet fuctio that has cosidered implemetig or is i the process of implemetig EDC o doubt uderstads that it takes more tha ew techology to reap its beefits. While EDC ca help streamlie the cliical trial process, to maximize the beefits of a paperless system, oe also must istitute ad maage chage across the orgaizatio as a whole. Put simply, fulfillig the promise of EDC requires maagers to effectively implemet a rage of operatioal chages. The authors of this paper have assisted i umerous successful global EDC implemetatios that achieved compay objectives ad expected beefits. Through that experiece, the authors have idetified a umber of critical success factors, must-haves ad must-avoids, ad geeral guidelies that maagers should follow if they are to realize EDC s full potetial. To share those key success factors, as well as commo mistakes to avoid, this paper is orgaized ito four parts: 1. Critical Success Factors i Global EDC Implemetatio 2. Five Steps to Successful EDC Vedor Selectio 3. Process ad Role Chages Required to Successfully Implemet EDC 4. Effective Testig, Traiig, ad Rollout of EDC Solutios While this paper is ot iteded to be a comprehesive guide to EDC selectio ad implemetatio, it is iteded to provide a framework that will help maagers pla their efforts, orgaize their thikig, ad guide their actios. PART 1: CRITICAL SUCCESS FACTORS IN GLOBAL EDC IMPLEMENTATION CRITICAL SUCCESS FACTOR ONE: STRONG LEADERSHIP AND AN UNDERSTANDING OF EDC S CHALLENGES Makig EDC the ew stadard i a orgaizatio requires uambiguous executive support ad strog project leadership. All areas withi ad aspects of cliical developmet are affected by the chage. Through experiece, the authors have leared that successful EDC projects must ivolve the followig key roles: Executive sposor usually the vice presidet of Cliical Developmet Project sposor usually the seior director of Cliical Operatios Steerig committee members, icludig the most seior Biostatisticia Data Maager Moitor (Cliical Research Associate (CRA)) Study Maager Cliical Iformatio Techology (IT) Specialist Medical Director Seior Project Maager, who serves as the dayto-day project leader Commo Mistake: Treatig EDC as a Data Maagemet or a Cliical Operatios issue Clearly, Cliical Moitorig, Data Maagemet, ad Study Maagemet are affected by EDC. However, the Biostatistics ad Medical Director fuctios, both of which ofte serve importat support roles i cliical trials, are also itegral to the success of EDC. As such, cliical developmet leadership must gather ad icorporate these groups iput to the EDC processes. Commo Mistake: Allowig the iteral IT fuctio to drive the implemetatio process EDC implemetatio is ot simply a computer system implemetatio. I fact, EDC techology is oly the tool that eables the critical chages that lead to beefits. However, sice IT has traditioally maaged ew systems implemetatios ad sice IT

2 Realizig the Promise of Electroic Data Capture A Practical Guide is typically structured to maage iteral projects, may EDC efforts are give over to IT to lead. While IT is a absolutely critical compoet of a project, if the project is perceived as beig drive by IT, ed users acceptace of the system may be hampered. Uless Study Maagers, Data Maagers ad Moitors, ad other key fuctios are ivolved i the implemetatio, few beefits or expectatios will be realized. Commo Mistake: Igorig kowledge gaied from past EDC experieces ad exteral vedors Prior to lauchig a major EDC iitiative, realistic assessmets of the challeges ahead must be coducted. Most cliical developmet orgaizatios iterested i makig EDC the stadard have some experiece with it either through utilizig i-house systems, workig with CROs that employ a system, or outsourcig the EDC portio of a study to a EDC vedor. The key for cliical developmet orgaizatios is to capture the learigs from these experieces to ehace future, full-scale implemetatios. Commo Mistake: Choosig the wrog techical approach A umber of potetial system opportuities exist. Tools are available to build EDC systems iterally. However, may orgaizatios rely o exteral techology vedors for EDC implemetatio. While the vedor area remais fragmeted, several leaders have emerged: Phase Forward Oracle eresearch Techology Phoeix Data Systems Medidata Solutios DATATRAK etrials Niaza Give the rage of optios, the project leadership team must have a clear EDC strategy to esure the correct techical approach is selected. CRITICAL SUCCESS FACTOR TWO: SET AGGRESSIVE TARGETS Oe of the primary resposibilities of project sposors ad the steerig committee is to establish explicit targets for the EDC project, relative to both timelies ad beefits. Aggressive beefits targets ecourage the implemetatio team to move from simply istallig the system to questioig how cliical developmet processes ad procedures ca be improved overall. While a fie lie exists betwee aggressive ad ureasoable goals, compaies with cautious targets ofte fail to realize the full potetial of their chage efforts. Commo Mistake: Allowig too much time for implemetatio EDC implemetatios, like all major projects, must have mometum. I most cases, the most successful iitiatives are those with aggressive targets. Although EDC programs are highly complex ad ivolve a large umber of movig parts, fasttrackig implemetatio provides better results. Establishig a strog sese of urgecy, as well as a bold timelie, makes dedicatig resources ad completig tasks more efficiet. Commo Mistake: Settig reasoable beefit expectatios ad targets May compaies develop their project beefits targets i a group eviromet, such as a steerig committee meetig. Doig so ofte results i lowest commo deomiator targets that are selected because they are the least objectioable to a rage of stakeholders. While these targets support easy cosesus, they fail to drive chage. Istead, aggressive beefits should be developed by the executive sposor ad shared with steerig committee members for their commets ad support. The executive sposor should actively defed the beefits targets to esure the pressure to produce results remais high. Examples of typical beefits iclude: five-fold reductio i umber of maual queries, two week last subject/last visit(lslv) to database lock (DBL) ad reductio of data maagemet outsourcig by 20%. CRITICAL SUCCESS FACTOR THREE: MAKE PROCESS REDESIGN THE CENTER OF THE CHANGE To beefit from EDC systems, everyoe ivolved i cliical operatios must modify the way they work. From the CRA s approach to site visits to the data maager s approach to database lock, every aspect of cliical operatios must chage to leverage the techology. These process chages must be defied i advace of the system rollout. Defiig the ew processes should be the basis of the etire EDC effort. Commo Mistake: Adaptig techology to existig processes Work processes are ofte refied over a umber of years. I most cases, they have bee revised over time to support the existig paper-cetric eviromet. Attemptig to modify EDC software regardless of whether it is packaged or custom built to support existig work processes will lock i all the iefficiecies i the curret eviromet. I cotrast, adaptig work processes to the ew software eables compaies to fully leverage the techology. By redesigig work processes to optimize beefits of the techology, less time will be ivested i system programmig, ad future support eeded for the system will be reduced. While a few key system compoets may require special programmig, the barriers to supportig these chages should be miimal. Commo Mistake: Limitig process chage to system support oly While adaptig to the ew techology is critical, a EDC implemetatio offers the uique opportuity for a wholesale review of curret operatig processes. I additio to those chages drive purely by the EDC system, other o-system-drive issues also should be examied. As such, EDC sposors ad the steerig committee eed to clearly support the etire rage of process chages that ca add value to cliical operatios.

3 Figure 1.1: Key Process Chages Required for EDC Maage Study Performace Most EDC iitiatives fail whe fudametal chages to busiess processes are igored. 2 Study Iitiatio 3 Study Moitorig 3 Query Executio 1 Study Data Requiremets Defied 2 ecrf Developmet 3 Data Quality Assured 4 Study Closeout 1 Data Maagemet must start 2 Data checks must be built o 3 Site moitors must alter their 4 Curret approach to study cleaig data at the begiig the frot ed. approach to ad frequecy of closeout must be restructured of the study. site visits, chagig key procedures ad metrics. to esure more rapid turaroud. CRITICAL SUCCESS FACTOR FOUR: USE A PROVEN PROCESS CHANGE METHODOLOGY Effective process chage requires the right balace of risks ad rewards. While it may be efficiet to tackle all process chages i a sigle meetig, doig so rarely reduces the risk of failure. Typically a tested ad prove process chage methodology offers the best opportuity for esurig that both efficiecies ad risks are well maaged. Campbell Alliace s RAPID EDC Methodology, for example, typically calls for the process to be broke ito 5 to 10 sub-processes for purpose of redesig. Commo Mistake: Redesigig with the wrog people The complexity of day-to-day activities must be cosidered whe redesigig processes. Successful redesig projects ivolve experieced lie-level persoel that support a specific fuctio. While it is temptig for seior maagers of a give fuctio to drive the process, they are ofte so far removed from curret operatig coditios that they overlook key details i the redesig. Rather tha ivolvig themselves i process chage, seior maagers should serve as soudig boards to teams of lie-level persoel that are empowered to affect chage. A soud methodology should support this relatioship. Commo Mistake: Treatig phase 1 studies ad phase 2-4 studies the same While the work processes i phase 1 studies share may of the same steps ad procedures as phase 2, 3, or 4 studies, the eeds of phase I studies are sufficietly uique to require special attetio. However, whe processes are redesiged across all phases, they are typically drive by the eeds of phase 2-4 studies. If phase 1 processes are ot cosidered separately, the opportuity to gai phase 1 staff acceptace ad ultimately achieve project beefits for phase 1 studies is reduced. While some orgaizatios have goe so far as to implemet separate EDC systems for phase 1 ad phases 2-4, typically, a sigle system with specially tailored phase 1 work processes ca suffice. CRITICAL SUCCESS FACTOR FIVE: MANAGE ORGANIZATIONAL CHANGE EDC implemetatio ivariably alters the aligmets ad resposibilities of various roles i cliical developmet. For example, EDC ca sigificatly alter or elimiate some roles i CRF developmet, ad EDC ofte drives chage i the roles of ad relatioship betwee Data Moitorig ad Data Maagemet. As a result, orgaizatioal chage must be maaged as actively as process chage. Ad ideally, orgaizatioal chages should be rolled out simultaeously with the ew EDC system ad ew work processes. Commo Mistake: Separatig process chage from orgaizatioal chage Give that process chage is best supported by lielevel persoel ad orgaizatioal chage is usually drive by seior maagemet, it is temptig to treat them as two separate, parallel processes. However, this approach requires the two visios be recociled before implemetatio is fialized. This recociliatio typically occurs ear the ed of the project after both visios have bee fleshed out. The result is a mad scramble to make chages where the two visios diverge. Usually, orgaizatios are most successful whe they allow the redesiged processes to be the primary driver of orgaizatioal chage. By doig so, orgaizatioal chage ca be coducted to support ad alig with the process chage. CRITICAL SUCCESS FACTOR SIX: TEST BOTH SYSTEMS AND PROCESSES TOGETHER Ay ew computer system must be tested before it is rolled out. This is a stadard IT approach to system implemetatio. Yet, as metioed previously, the beefits of EDC are achieved through work process chages. Despite this fact, few orgaizatios joitly test the ew processes ad the EDC system. The authors experiece has show that a ed-toed process test utilizig the productio versio of the EDC system ca help avoid problems ad esure that work processes are followed.

4 Realizig the Promise of Electroic Data Capture A Practical Guide Commo Mistake: Relyig solely o IT to coduct testig Traditioal systems testig is ofte a techical effort drive by IT. Give the importace of joit processes ad systems testig, Campbell has foud that IT eeds to parter closely with cliical operatios stakeholders to coduct testig. Campbell also has foud that testig ca serve as a trai-thetraier opportuity, providig cliical operatios stakeholders with a broad uderstadig of both the system ad processes before coductig traiig. CRITICAL SUCCESS FACTOR SEVEN: DEDICATE THE RESOURCES NEEDED FOR TRAINING All the hard work ivolved i a EDC implemetatio is lost uless persoel are adequately traied o both the ew system ad work processes. Traiig should be desiged aroud ad provided to uique roles, especially if the resposibilities have chaged. Such traiig is best provided by those lie-level persoel who desiged ad/or tested the ew processes ad thus ca discuss the logic behid ew processes ad the system. I additio to dedicated traiers, EDC sposors ad the steerig committee eed to assume that all resources i cliical developmet will eed betwee oe ad two days of traiig approximately oe day for systems traiig ad half to three-quarters of a day for process traiig. Commo Mistake: Providig iadequate time for process traiig Surprisigly, there is ofte a strog resistace to providig adequate time for process traiig. Although i most cases the chages made to work processes ca be extesive, i may istaces leadership assumes at their risk that oe to two hours for process traiig will be sufficiet. Failig to provide adequate time for formal process traiig burdes persoel with havig to teach themselves usig whatever form of documetatio is available. Self-istructio o ew processes rarely produces adequate results. Orgaizatios should expect process traiig that supports EDC implemetatio to take betwee half ad threequarters of a day, depedig o the level of chage each role will experiece. A BRIEF CASE STUDY Now that the critical success factors ad commo mistakes associated with EDC implemetatio have bee described, it is helpful to review a example of a successful oe. The followig case study provides a solid overview of how to successfully maage chage withi a orgaizatio whe makig EDC the stadard. Backgroud A top 5 pharmaceutical compay faced a umber of major strategic issues. Its growig pipelie was placig great pressure o the Cliical Developmet fuctio. Ecoomic realities dictated agaist hirig more staff to hadle the icreased workload, so fuctio leaders eeded to chage the way the orgaizatio operated to do more with less. Oe critical decisio was to improve the efficiecy of cliical trials ad improve the speed of the capture ad maagemet of subject data by implemetig a paperless system. The authors firm, Campbell Alliace, was egaged to help the cliet redesig all global trial-related processes from ecrf developmet to study closeout for phases 1-4. Past EDC Experimets The compay had previously experimeted with a rage of EDC systems, icludig oe developed i-house. This proprietary, laptop-based system had bee developed ad deployed at a legacy orgaizatio. The solutio proved popular with both ivestigators ad study moitors. However, the system was cumbersome to maage ad difficult to recofigure as a solutio for all global studies, as it required the orgaizatio to provide each participatig site with a laptop cofigured specifically for each idividual study. I additio, the compay had utilized packaged EDC software solutios for several studies, but had ever moved beyod the experimetatio stage to realize the true beefits of the system. System Selectio The compay coducted a robust aalysis of its experieces to develop a list of key requiremets eeded from the EDC system. Next, persoel performed two separate system selectio processes oe for phase 1 ad aother for phase 1-4 studies. Both processes icluded reviews of the iterally developed ad the packaged EDC systems. Persoel coductig the separate reviews idetified the same optimal solutio ad selected the same packaged EDC system. Process Redesig: The Ceter of Chage Oe key take-away from the compay s past experiece with EDC was that it represets much more tha the implemetatio of ew techology. Maagemet uderstood that chagig the way the orgaizatio coducted cliical trials was cetral to realizig the beefit goals it had set. Simply implemetig EDC o top of paper processes would result i failure. The compay idetified two areas of focus that were critical to the success of their EDC effort: PROCESS REDESIGN: The authors worked with seior maagemet to establish a effective project structure that icluded resources from all critical fuctios, represetatio from differet global regios, ad subject-matter experts i key process areas. The project ivolved separate process redesig teams for phase 1 ad phases 2-4. Teams were structured to focus o specific aspects of the cliical trial process, such as ecrf creatio ad data moitorig. PROGRAM LEADERSHIP AND COMMUNICATION: The authors worked directly with the cliet s seior maagemet to provide guidace for this large udertakig, cofirm process chages were clearly uderstood ad accepted by leadership, ad esure processes drove system desig rather tha the other way aroud. Workig sessios were coducted with the project steerig committee at critical juctures to commuicate process ad orgaizatioal chage recommedatios, receive iput from the steerig committee, ad promote cosesus o appropriate chages amog steerig committee ad project team members. Overview of the Approach The authors used a well-developed methodology for redesigig busiess processes ad chagig orgaizatioal ifrastructures. I additio, the cliet brought its ow prove methodology to the effort.

5 A critical step i begiig the process redesig effort was to effectively combie these two methodologies to develop a sigle approach to process redesig ad orgaizatioal restructurig that would meet the cliet s targets ad expectatios i the aggressive time frame established. A high-level overview of the approach take to redesig busiess processes, maage orgaizatioal chage, test processes ad system together, ad trai key employees is provided below. Process Redesig The corerstoe of the process redesig efforts were two sets of three-day process redesig workshops for each critical fuctio area. I the first workshop, process redesig teams were tasked with defiig high-level ehaced busiess processes ad idetifyig process chages required to implemet the ehaced processes. Team members were assiged as champios of the process chage effort ad charged with removig barriers to successful implemetatio throughout the orgaizatio. Durig the three weeks betwee meetigs, team members resolved ope issues idetified durig the first workshop, commuicated the required process chages to their colleagues, ad geerated feedback o the teams recommedatios. Additioal iformatio gaied from these activities served as critical iput to the secod workshop. Durig the secod workshop, process redesig teams refied ad added details to the iitial to-be processes. The teams the idetified tools ad documetatio eeded to support executio of the redesiged processes. Work plas were developed, ad owers were assiged to developig the supportig tools ad documetatio. The authors worked closely with cliet team members to support commuicatio ad build idividual work plas. Next, they cosolidated idividual team member work plas ito work plas that would gover the developmet effort. Orgaizatioal Chage Oce processes were redesiged, the redesig teams idetified roles resposible for executig each step i the ew processes. The authors the facilitated a three-day workshop with the project steerig committee to discuss the ew processes ad associated roles, receive steerig committee iput, ad determie the potetial impact the process ad role chages would have o the Cliical Developmet orgaizatioal structure. Process ad System Testig Process ad system testig is critical for future success. Give the sigificat alteratios to the work to be coducted ad the global scale of those chages, testig the redesiged processes ad EDC system prior to coductig live cliical trials was crucial. As such, oce process ad role chages were agreed upo ad supportig tools ad documetatio were developed, more tha 75 detailed scripts were developed based o every potetial sceario a employee would ecouter while executig a cliical trial. These scripts icluded all redesiged process steps, as well as exercises to test whether the system, as desiged, would support the executio of the ew processes. The team also coducted a simulated study i which a cross-fuctioal team of employees executed all processes usig the system. This exercise idetified opportuities for improvig the processes ad supportig tools, documetatio, ad the system prior to goig live. Orgaizatio-Wide Traiig The sigificat chages stemmig from EDC implemetatio also required i-depth traiig for study team members. I additio to the system traiig, the team developed detailed traiig modules specific to critical roles ecrf developer, study moitor, data maager, ad study maager for cliical developmet staff. These traiig modules provided a detailed walk-through of all process steps i which each role was ivolved. Traiers, who had bee members of the process redesig teams, delivered role-specific traiig to their colleagues who would coduct cliical trials usig the ew EDC system. IN CONCLUSION For a EDC implemetatio project to achieve orgaizatioal goals, the critical success factors detailed above must be itegrated ito the program. While o magic bullet exists, cliical developmet orgaizatios will have a much greater opportuity to achieve beefit targets ad surpass expectatios if they follow the guidelies ad avoid the commo mistakes metioed above. Figure 1.2: Overview of EDC Implemetatio Approach Project Process Overview Time Develop EDC Goals ad Metrics Redesig Processes to Maximize Value Implemet Chages ad Trai Staff Work with seior maagemet to develop goals Idetify ad documet expected beefits Develop a pla for measurig performace agaist goals ad aticipated beefits Develop work processes to support the executio of cliical trials usig EDC Uderstad ad documet chages to critical activities such as study moitorig, data maagemet, ad study maagemet Test the executio of work processes usig the EDC system prior to goig live Traslate role chages ito potetial orgaizatioal chages Support the commuicatio of orgaizatioal chages Develop ad deliver traiig to support the executio of ew work processes usig EDC Measure performace agaist stated beefits

6 Realizig the Promise of Electroic Data Capture A Practical Guide Table 2.1 PART 2: FIVE STEPS TO SUCCESS- FUL EDC VENDOR SELECTION OVERVIEW Decreasig go-to-market time for idividual products, as well as the overall product pipelie, is a primary cocer of pharmaceutical compaies. A effective EDC strategy is essetial to achievig this goal. Movig from paper-based to electroic cliical trials creates several quatifiable beefits, icludig Faster study close-out: reduces time from last study/last visit (LSLV) to database lock by up to 70%¹ Reduced workload ad correspodig cost: reduces data etry, query maagemet, ad site moitorig workload, thus elimiatig a estimated $250,000 to $350,000 i costs per study To fully achieve these beefits, a compay should leverage EDC techology to complete the followig key activities: Capture of cliical trial data electroically at the ivestigator site Real-time query geeratio ad resolutio Itegratio of data with back-ed systems, such as a cliical trial maagemet system (CTMS) ad statistical aalysis software Remote moitorig of study ad site performace by Study Maagers ad Site Moitors The success of these activities is largely determied by the selectio of the most appropriate EDC vedor. This white paper will provide readers with tools ad isights to Model ASP Techology Trasfer The ASP ad techology trasfer models are described i Table 2.1 above. The authors believe that ASP vs. techology trasfer is ot a either/or decisio. Rather, the choice correspods to differet poits i a orgaizatio s progressio towards full commitmet to coductig EDC trials. The ASP model is appropriate for compaies experimetig with EDC. The model eables customers to realize some beefits of EDC trials o a study-bystudy basis, without havig to make a commitmet to a sigle vedor. While this allows compaies to gai experiece with EDC techology, may of the beefits of EDC are ever realized through the ASP model. Table 2.2 below explores advatages ad disadvatages of the ASP model. Table 2.2 Descriptio Vedor ows ad hosts the software o its servers. Customer pays a mothly subscriptio fee for use of the software. Vedor provides professioal services to hadle study setup ad electroic case report form (ecrf) desig. Customer purchases the software, which may be hosted o its or the vedor s servers. Customer tailors the software as appropriate to meet its specific operatioal eeds. Customer resources coduct all study set up, ecrf desig, ad study coduct activities. I cotrast, the techology trasfer model is more appropriate for compaies makig a commitmet to coductig the majority of their cliical trial electroically. I order to realize the full beefits of EDC, a compay must: Redesig cliical trial processes ad orgaizatioal structures Customize the software to support redesiged processes Implemet ad test software ad processes i tadem Trai resources o ew EDC-focused job fuctios Coduct pilot EDC studies, lear from those experieces, ad revise processes, orgaizatioal structure, ad software accordigly Maage the chage util EDC is the stadard method for capturig, aalyzig, ad maagig cliical trial data Better uderstad the EDC techology vedor ladscape Apply a disciplied, pragmatic process to EDC vedor selectio efforts Evaluate EDC vedor capabilities usig a realworld approach DECIDING WHETHER TO RENT OR BUY Prior to selectig a EDC vedor, pharmaceutical compaies must decide whether to ret the capability through a applicatio service provider (ASP) model or buy the capability through a techology trasfer arragemet with their vedor of choice. Approach ASP Advatages Allows compaies to try multiple packages Limits orgaizatioal commitmet process ad orgaizatioal desig are ot expected Costs less tha techology trasfer o a sigle-study basis Allows studies to be up ad ruig i a matter of weeks Disadvatages Offers few quatifiable beefits Fails to capture key learigs at the operatioal level, as key processes are executed by the vedor Costs more tha techology trasfer o a relative basis Limits staff learig curve by testig differet vedor packages Icreases cofusio amogst staff ad ivestigators through lack of commitmet to a sigle solutio

7 Table 2.3 Approach Techology Trasfer Advatages Drives sigificat fiacial ad efficiecy beefits Supports orgaizatioal evolutio toward fully automated cliical trials Eables staff to become fuctioal experts i EDC techology Forces stadardizatio ad cosistecy of cliical trial processes throughout the orgaizatio Table 2.3 above explores advatages ad disadvatages of the techology trasfer model. I order to make the ret vs. buy decisio, compaies must determie where they stad i the progressio from paper-drive to electroic trials. Is the compay still learig ad developig a comfort level with EDC techology? Or is it ready to stadardize o oe platform? Wherever the orgaizatio is i its progressio betwee iitial evaluatio ad total commitmet to EDC, it is ecessary to make the ret vs. buy decisio prior to begiig vedor selectio. THE EDC VENDOR SELECTION PROCESS Key steps to successfully idetifyig potetial solutio providers, evaluatig their capabilities ad busiess models, ad ultimately selectig the right parter to meet the compay s eeds iclude the followig: Step Oe: Categorize Solutio Providers Oe of the most cofusig aspects of choosig a EDC solutio provider is avigatig the fragmeted vedor ladscape. Compaies ca simplify their selectio process by segmetig EDC providers ito the followig categories: Table 2.5 Disadvatages Demads higher iitial fiacial ad time ivestmet Requires sigificat commitmet from multiple fuctioal areas Requires redesig of cliical trial processes, chages i multiple roles, ad sigificat re-traiig of staff ecliical Suite Providers: Vedors i this category provide a rage of ecliical solutios icludig EDC ad CTMS, as well as peripheral solutios like patiet diaries ad iteractive voice respose systems (IVRS). Vedors i this category iclude etrials, Phase Forward, ad Oracle. EDC Specialists: These vedors exclusively provide EDC solutios. It is critical that the specialist s solutio ca be easily itegrated with other cliical systems. Vedors i this category iclude Medidata, eresearch Techologies, ad Datatrak Iteratioal. Late-Stage Specialists: These specialists offer solutios that meet the specific eeds of late-stage, or post-marketig studies such as Phase IV, ivestigator iitiated studies (IIS), ad patiet registries. Vedors i this category iclude Niaza ad Outcomes Research. Step Two: Ivolve the Right Players Compaies too ofte view selectio of a EDC vedor as a exercise drive by the IT ad Data Maagemet groups. While IT ad Data Maagemet are clearly stakeholders i the process, they are by o meas the oly critical parties. Give the wide implicatios of usig EDC techology, it is recommeded that a cross-fuctioal team of executives be formed to cosider the optimal solutio. This team must iclude represetatio from all cliical trial phases beig cosidered. A ideal selectio committee costructio may look like this: Figure 2.6: Sample EDC Implemetatio Team Cliical Operatios Co-lead Data Maagemet Co-lead IT-Applicatio Developmet Advisor IT-Ifrustructure Maagemet Advisor Therapuetic Area Represetatives Advisor Pre-Cliical Represetative Advisor Medical Affairs Represetative Post-marketig Advisor Figure 2.4: Overview of EDC Vedor Selectio Process 1 Categorize Solutio 2 Ivolve the Right 3 Lear From Your 4 Narrow the Playig 5 Evaluate Cadidate Providers Players Experieces Field Further Solutios i a Real- World Settig

8 Realizig the Promise of Electroic Data Capture A Practical Guide Table 2.7: Vedor Evaluatio Checklist Step Three: Lear From Your Experieces Most pharmaceutical compaies have coducted at least oe cliical trial usig some form of EDC ad ca build upo this istitutioal kowledge. Past experieces with specific EDC providers is critical iformatio to gather, as there is o research more valuable tha past experiece. Key questios that will help a compay gai isight based o its experieces iclude: What vedors has the orgaizatio worked with i the past? How may studies did each vedor support for the orgaizatio? I what phase was each of those studies? Which vedors have worked i what therapeutic areas? What elemets of each vedor s product suite did the orgaizatio utilize? Was the study maaged by the orgaizatio or through a CRO? What were the positive experieces with each vedor? What were the egative experieces with each vedor? I the case that a orgaizatio has o specific istitutioal kowledge, iformal etworkig amog peer compaies at idustry evets ad orgaizatio meetigs ca serve as a rich source of iformatio. Idustry aalysts ad cosultats ca also provide valuable isight. However, it is critical i solicitig peer advice to cosider the source ad ay icetives they may have to recommed a particular solutio provider. Step Four: Narrow the Playig Field Further After categorizig vedors ad gaiig isight from istitutioal experieces ad peers, a compay should develop a short list of two to four EDC solutio providers. This short list should be comprised of providers with the potetial to meet a orgaizatio s specific eeds. The eeds that drive the developmet of requiremets for a EDC system vedor iclude iteded use of the EDC system ad specific features of the orgaizatio s cliical trial processes. Usig the followig vedor evaluatio checklist, a orgaizatio cosiderig their EDC optios ca catalogue the critical elemets of each vedor s solutios, ragig from techical modules to professioal services support. Evaluatio Category Phases supported Product suite ad itegratio with other tools Reportig Etry ad maagemet of user iformatio Coduct of source data verificatio (SDV) Freezig ad lockig mechaisms Study maagemet Safety reportig Supportig services Compay experiece ad viability Elemets of the Evaluatio Phase 1 Phase 2-3 Phase 4 CDMS IVRS Patiet diaries Reportig tool SAS/statistical tools Safety reportig Milestoe trackig ad paymet tools Types of reports available Study maagemet reports Site maagemet reports Presetatio of reports Source of reports (provided by a itegrated reportig module or a pure play vedor such as Cogos or Crystal Reports) Sposor ad site iformatio Pre-go-live ad post-go-live Mechaism for coductig SDV off-lie? Level of freezig ad lockig Case book Form User rights for freezig ad lockig Study home page or portal Itegrated part of the solutio or additioal solutio required? Site techical provisioig Help desk Traiig of sposor ad ivestigator persoel Professioal services Number of customers Number trials supported i relevat, specialized therapeutic areas, if appropriate Solutio roadmap Cash flow ad log-term viability Compay growth plas

9 Step Five: Evaluate Cadidate Solutios i a Real- World Settig Oce the playig field has bee arrowed to two-tofour cadidates, a compay ca begi to evaluate the solutios agaist their most specific requiremets. I order to truly uderstad whether a EDC solutio will meet the eeds of a orgaizatio, it must test the system i its ow cliical trial process. Usually, a sceario-based testig exercise is appropriate, i which cadidate EDC solutio providers execute critical cliical trials processes based o scripts ad data provided by the orgaizatio. While developig scripts ad sharig relevat data with EDC vedors creates extra work for a orgaizatio, the exercise provides the most realistic opportuity short of actual trial coduct to observe the cadidate solutios i actio. Followig are a set of recommeded scearios to test: ecrf developmet, icludig the creatio of edit checks ad testig Site techical evaluatio ad provisioig Site techical traiig Importatio of study user ames ad profiles both sposor ad site ito the system Creatio ad viewig of site-specific performace reports Electroic source data verificatio Freezig of data ad lockig of forms Study close-out activities As sceario-based exercises are coducted, each vedor should be evaluated ot oly o its solutio capabilities but as a potetial parter i future EDC edeavors. The followig criteria ca be used: How well did the solutio meet specific requiremets? What level of customizatio will be required? I order to truly uderstad whether a EDC solutio will meet the eeds of a orgaizatio, it must test the system i its ow cliical trial process. How much techical traiig will be required to comfortably coduct cliical trials usig the system? How resposive was the vedor to requests, ad how comfortable were iteractios with the vedor s maagemet ad staff? How ope was the vedor to providig critical experiece ad fiacial iformatio? IN CONCLUSION The fragmeted vedor ladscape, lack of a oesize-fits-all solutio, ad complex requiremets of the cliical trial process ca make the task of idetifyig, evaluatig, ad selectig a EDC parter appear dautig. Egagig EDC providers i a ASP model is oe way to reduce complexity, but this optio fails to geerate the promised beefits of EDC. To fully receive these beefits, a orgaizatio should select a provider offerig a techology trasfer approach to EDC. Orgaizatios ready to commit to EDC as their stadard method for collectig, aalyzig, ad maagig cliical trial data should follow five key steps i selectig a EDC parter: 1. Categorize Solutio Providers 2. Ivolve the Right Players 3. Lear From Your Experieces 4. Narrow the Playig Field Further 5. Evaluate Cadidate Solutios i a Real-World Settig The orgaizatio that is willig to ivest the time, eergy, ad focus ito methodically executig the five critical steps of EDC vedor selectio icreases its chaces of developig a successful partership ad, ultimately, realizig the promised beefits of EDC.

10 Realizig the Promise of Electroic Data Capture A Practical Guide PART 3: PROCESS AND ROLE CHANGES REQUIRED TO SUCCESS- FULLY IMPLEMENT EDC OVERVIEW To say that coductig a cliical trial is a complex udertakig would be a serious uderstatemet. Coductig cliical research meas maagig everythig from creatig case report forms, through moitorig sites, to lockig databases. It ca ivolve umerous sites ad thousads of subjects i multiple coutries aroud the world ad that is whe thigs go smoothly. I reality, cliical research also ivolves resolvig coutless queries, recruitig ofte hard-to-fid subjects, ad cleaig moutais of data, all while edurig itese regulatory scrutiy. I other words, coductig a cliical trial is hard work. Yet over the years, pharmaceutical firms, biotechology compaies, ad research orgaizatios have foud a way to make it happe. So is it ay surprise that these same cliical developmet orgaizatios are ot eager to give up o a system they believe already works i order to implemet electroic data capture (EDC) techology that requires chage to this already complex system? It is this very resistace to chage that cotributes to the fact that almost 70% of EDC implemetatios fail to meet expectatios¹. Orgaizatios try to implemet the techology without adaptig the cliical developmet processes that support it. They are the disappoited whe they do ot recogize all the promised payoffs of EDC. The beefits of EDC, such as simplified site moitorig, elimiatio of double data etry, ad faster database lock, are oly realized by orgaizatios that are willig to tackle the orgaizatio ad process chages ecessary to support the techology. I this sectio (Part 3), we will discuss what chages are ecessary for implemetatio ad how best to go about makig them. SUMMARY OF EDC-DRIVEN PROCESS CHANGES EDC is more tha just ew techology; it s a ew way of thikig about cliical trials. Implemetig EDC while maitaiig the processes that supported a paper-based system is like tryig to play a CD o a turtable. The techology is oly effective whe it is supported by the right base of busiess processes. Oe fudametal premise regardig the success of EDC is that the beefit potetial will ot be reached uless cliical trial processes are redesiged ad key roles are updated so that they itegrate efficietly with the EDC solutio. These process chages must occur at several key poits alog the cliical trial process, as illustrated i the diagram below. The critical process chages start with defiig the study data requiremets (Fig. 3.1, A). I a traditioal, paper-based cliical eviromet, defiig these requiremets is a iterative process that is doe i cocert with case report form (CRF) developmet. As the CRF evolves, so do the data requiremets. This back ad forth process is extremely time-cosumig, as it leads to delays due to revisios, false deadlies, ad geeral cofusio. Whe implemeted, EDC solutios make it very difficult to edit the data requiremets that uderlie the electroic case report form (ecrf). Effective cliical developmet orgaizatios will view this coditio as a opportuity to create a well-defied set of study data requiremets o the frot ed. Whe critical issues like desired data edpoits ad structure of site visits are addressed as fial o the first go aroud, the time-cosumig revisios ad misleadig deadlies ca easily be avoided. Whe data requiremets are thoroughly developed o the frot-ed, the creatio of ecrfs becomes much easier (Fig, 3.1, B), ad EDC ca begi deliverig tagible efficiecy gais. A ecrf must be built i a serial fashio, ad havig a strog set of data requiremets facilitates a smooth buildig process. It is oly whe cliical orgaizatios maitai the paper-based traditio of jumpig back ad forth betwee edits to the study requiremets ad edits to the ecrf that implemetig EDC becomes a burde istead of a beefit. Process chage is also critical i study moitorig (Fig. 3.1, C). EDC makes it possible for Site Moitors to gather iformatio o a cotiuous basis without havig to make as may site visits. This shift i capabilities requires the uderlyig resposibilities ad procedures to be altered if beefits are to be realized. The attributes of a successful Site Moitor shift sigificatly oce EDC is implemeted. The most obvious eed is for a icreased degree of techical Figure 3.1: Poits of Critical Process Chage for EDC Maage Study Performace B Study Iitiatio C Study Moitorig C Query Executio A Study Data Requiremets Defied B ecrf Developmet C Data Quality Assured D Study Closeout

11 kow-how. EDC allows those with the ecessary techical skills to successfully moitor the sites without the frequet site visits required uder a paper-based system. I tur, site moitors must have the commuicatio skills to build ad foster relatioships remotely, as their degree of live iteractio with ivestigators sigificatly decreases. I additio to the shiftig ature of ivestigator relatioships, remote moitorig also meas that data is costatly beig collected. I order to keep up with this more rapid stream of iformatio ad the simultaeous flow of data from multiple locatios, a successful Site Moitor must possess strog project maagemet skills. More effective project maagemet is the drivig force that eables the more rapid study closeout (Fig. 3.1, D) promised by EDC. Paper-based cliical orgaizatios ofte experiece the greatest delays at study closeout. Traditioally, this was whe the data first bega to be cleaed. Creatig ad replyig to all the queries at oe time created a sigificat bottleeck i the closeout process. Implemetatio of EDC solves this problem because a effective Site Maager ca resolve data issues as they occur. Whe query resolutio is successfully maaged throughout the moitorig process, the study closeout becomes more streamlied ad free of traditioal paper-based study roadblocks. ROLE CHANGES IN CLINICAL DEVELOPMENT As cliical processes chage, so must the uderlyig roles. The EDC trasitio primarily affects cliical roles i three areas: data maagemet, site moitorig, ad study maagemet. These role chages do ot just affect the core cliical staff; they affect everyoe with a had i the cliical process. Usig EDC, data maagemet begis earlier i the study cycle. Because ecrfs must be built i a serial fashio, there is a stroger icetive to correctly defie the data requiremets the first time. To accomplish this goal, iput is gathered from a wider rage of participats, icludig the site staff that will be collectig the data i the field. EDC also affects data maagemet durig the site moitorig process. Site Moitors, Ivestigators, ad site staff should all expect a shift i workload from a post-study peak to a steady flow through the life of the study. While the umber of live site visits may decrease with EDC, the amout of iteractio betwee site moitors ad site staff greatly icrease to support the cotiuous flow of data ad related queries. I fact, the site staff s role is greater throughout the etire cliical process. Oce the ecrf is completed ad the study begis, the remote access capabilities eabled by EDC mea that the role of the primary site cotact must be realiged to support the costat stream of data. The ability to directly query a site throughout the study meas that the primary site cotact s role is much more active ad ivolved. This ability to costatly query sites ad collect data also creates a shift i study maagemet resposibilities. To leverage this improved data access, study maagers must chage their approach to reportig study progress to icorporate the ew iformatio that is costatly available. Icreased access to data also allows study maagers to make decisios i a more real-time maer. To do this effectively, they must develop ew approaches to idetifyig ad resolvig study-wide ad site-specific issues o a ogoig basis. Table 3.2 ecrf Developmet Study Iitiatio Site Moitorig Query Maagemet Ogoig Data Maagemet ad Database Closure Study Closeout Study Performace ad Reportig KEYS TO SUCCESSFUL CLINICAL TRIAL PROCESS CHANGE Key Oe: Set measurable goals ad break the process up ito maageable pieces It is easy for a orgaizatio to commit to usig EDC as its stadard for executig cliical trials. It is much more difficult to uderstad how to make that commitmet a reality. Realistically, orgaizatios plaig to covert their cliical operatios to EDC must create smaller, more-actioable, icremetal goals for implemetatio. This is doe by breakig the process up ito maageable pieces. I cliical developmet, eve the smallest task has multiple stakeholders who must be ivolved i the itegratio of EDC. After all, the cliical trial process is a highly complex udertakig, comprisig multiple sub-processes that are depedet upo the successful executio of the others. So it is best to break the process ito logical sub-processes for the purpose of redesig, the re-assemble the ed-to-ed cliical trial process at the coclusio of the exercise. Followig is a logical breakdow of cliical trial sub-processes: Processes ivolved from developig study-specificatios through publishig the ecrf All tasks required to prepare study teams ad sites for study coduct Activities required to effectively moitor sites usig EDC, from first subject/ first visit, through source data verificatio, to last subject/last visit Processes focused o addressig ad closig all types of queries geerated durig the executio of a study Maagemet of data durig the course of a study ad all activities required to prepare the study database for closure Steps required to archive site ad study data, remove site access to the EDC system, ad decommissio techical ifrastructure Iformatio ad reports made available by EDC ad required to more effectively maage a EDC study

12 Realizig the Promise of Electroic Data Capture A Practical Guide Breakig the cliical developmet process dow ito these smaller pieces is the most effective way to maage the chage of such a complex process. Key Two: Treat process redesig as a global, Cliical Developmet-wide effort While creatig maageable pieces is effective, treatig the redesig process as a solely techical fuctio is ot. Oe of the greatest temptatios of orgaizatios implemetig EDC is to take the path of least resistace ad treat EDC as a Data Maagemet effort. While Cliical Data Maagemet has a large stake i the outcome of a EDC implemetatio, it is clearly ot the oly group affected. It is oly through icludig all affected groups withi a cliical orgaizatio that EDC is successfully implemeted. The redesig effort eeds to iclude iput from each of the followig groups, ad these groups must also edorse the fial outcome of their combied efforts. Cliical Data Maagemet Moitorig Biostatistics Cliical study teams Safety Developmet Iformatio Techology Regulatory ad Compliace Beyod icludig these fuctioal groups, compaies with a global presece must also accout for regioal differeces i how trials are coducted. This icludes recogizig regioal uaces i the process ad orgaizatioal structure withi their ow orgaizatio. Key Three: Redesig as a group I order to effectively iclude all of the process stakeholders while simultaeously addressig the complexities of each cliical sub-process, orgaizatios should tackle redesig as a group. Ulike other redesig efforts, cliical developmet is ot a process that is effectively addressed through a study ad report model. While coductig fact-fidig iterviews about the curret process ad reportig back with a suggested ew process may be effective for simple redesig efforts, those who attempt to apply the typical study ad report model to cliical developmet are geerally usuccessful. Give the criticality ad complexity of the cliical trial process ad the multiple departmets affected by its redesig, the authors believe that the oly way to effectively redesig the process is as a group. A group structure allows for the eeded iteractio amog the stakeholders for each cliical developmet sub-process. Each sub-process should be redesiged by a crossfuctioal team focused specifically o the detailed activities ivolved i a particular process. The team should iclude represetatives from the fuctioal areas most likely to be affected by or have ifluece o the chages geerated by the team. For example, the study moitorig process redesig team should iclude more tha just Moitorig staff. Cliical Data Maagemet ad Cliical Team staff should also be ivolved, because the activities ad processes of all three fuctios are iterdepedet. I the same maer, global orgaizatios must look beyod fuctioal iterdepedecies to iclude the perspectives of the moitorig staff i differet regios so that the redesiged study moitorig process also accouts for varyig global practices. Such iclusive redesig teams are able to focus o creatig ideas ad developig solutios creatively ad quickly. I the authors experiece, it has bee useful to hold two process redesig workshops durig the redesig phase, spaced two to three weeks apart. Followig is a overview of each workshop, as well as the activities coducted durig the period betwee workshops. Table 3.2 Process Redesig Workshop Oe Iter-Workshop Period Process Redesig Workshop Two At the ed of the workshop process, the members of the process redesig teams will be the true EDC experts withi their orgaizatio. Their uderstadig of the processes is ecessary to support successful executio of studies, ad they will serve as metors to their colleagues durig the orgaizatio s trasitio to EDC. Workshop participats are wellpositioed for this role, as they are the oes who developed the solutios. Key Four: Create a culture of owership Of course, the process redesig groups ca oly develop effective solutios if they are empowered to do so. A orgaizatio must commit ot oly to implemetig EDC, but also to implemetig the ecessary process chages. Seior-level support must be give to each process redesig group so that they ca make the chages ecessary to truly affect their particular sub-process. This ability to affect chage is particularly importat because trasitio to EDC creates may opportuities to improve processes that have othig to do with EDC. I a system as complicated as cliical developmet, it is rare that sweepig chages ca be made. The opportuity to make chages throughout the cliical developmet process is ot oe that orgaizatios should take for grated. After all, the complexity of cliical trials ad the ecessary degree of regulatory scrutiy has created a culture withi may cliical developmet orgaizatios where overbearig checks, reviews, Teams iitially focus o uderstadig the scope of their sub-process ad their beefit goals. Upo reachig agreemet, teams develop a high-level, first-draft process flow ad capture the key chage ideas icorporated i the redesiged process. This icludes idetifyig ay issues ad barriers stadig i the way of makig the chage ideas a reality. Team members meet with appropriate colleagues throughout the orgaizatio to discuss key chage ideas ad uderstad how best to resolve issues ad remove barriers. Teams meet regularly to discuss progress, resolve issues, ad discuss topics that will ultimately iform the fializatio of ew processes i redesig workshop two. Teams recovee to apply fidigs from their activities sice the first workshop, fialize the redesiged processes, ad idetify the roles that will execute each activity i the redesiged processes.

13 sigatures, ad documetatio are the orm. While process redesig teams are examiig the cliical developmet process from the perspective of EDC, they must also kow that they are free to challege these cultural orms ad break the rules put i place over time. This allows for the removal of process steps that do ot ultimately add value to the ed result. The resultig culture of owership is what drives successful EDC implemetatio ad the orgaizatio s ability to reap the beefits of this techology. Key Five: Create geeralists out of specialists Beyod process owership, the group workshop format also realigs idividuals perspective so that they see the cliical developmet process as a iterrelated whole. This is importat because over time, cliical developmet orgaizatios have evolved ito groups of highly specialized roles that focus oly o specific elemets of the cliical trial process. Orgaizatios beefit from this specializatio i that idividuals become very efficiet ad effective i their desigated roles. At the same time, specializatio ca cause idividuals to lose visibility ito how their work affects the work of others. As the orgaizatio begis the ed-to-ed process redesig effort, idividuals withi the orgaizatio must be acutely aware of how chages to oe part of the process ca greatly affect positively or egatively the success of other seemigly ucoected steps i the process. Creatig this awareess is as simple as puttig represetatives from differet specialized areas i a room to discuss the process together. I this eviromet, idividual participats are forced to thik as members of the broader orgaizatio. As a result, the revised processes the group desigs to support EDC implemetatio will support the broader orgaizatioal eeds. Key Six: Lik closely with techical implemetatio I additio to experts from each fuctioal area, workshop groups should also iclude techical experts. While cliical trial process redesig ad implemetatio of the EDC system travel alog separate parallel paths, they are iextricably liked i the sese that each work stream must iform the activities of the other. This coectio is supported through techical represetatio o the process redesig teams. These resources ca be from the orgaizatio s iteral IT group or from the EDC software provider. The key is that they are experts i the fuctioality of the software ad ca provide iput regardig the software s ability to effectively support the redesiged processes the team is creatig. It is also helpful to create issue-focused workig groups to tackle techical issues related to process redesig. These groups ca be focused o may differet issues. The most commo of these issues iclude the followig: Log-term itegratio of systems to create a fully itegrated ecliical ifrastructure Icorporatio of exteral data, such as IVRS, labs, ad patiet diaries Hadlig of severe adverse evets (SAEs) Core cofiguratio of the EDC system Key Seve: Test processes, system, ad supportig tools together All efforts i implemetig EDC techology ad redesigig cliical trial processes are i preparatio to support the orgaizatio i coductig cliical trials i the most efficiet maer possible. The first study teams to execute redesiged processes usig EDC will be operatig i a eviromet of chage ad ucertaity, ad must be effectively supported. It is durig the executio of these iitial studies that the stakes are highest positive experieces will geerate support for the iitiative, while egative experieces could stall the orgaizatio s efforts ad lead to iadequate adoptio ad lowered retur o ivestmet. It is recommeded that, prior to supportig iitial study teams, orgaizatios test redesiged processes ad supportig tools, alog with the EDC system, i as real-world a eviromet as possible. This exercise, kow as a Coferece Room Pilot, simulates the coduct of a cliical trial from ed to ed usig scearios that documet all activities i the trial. Role players execute redesiged processes, eter data ito the EDC system, ad use supportig tools for guidace, while observers documet ay ad all chages required. The Coferece Room Pilot serves as a highly valuable fial step i the process redesig exercise, eablig orgaizatios to fid potetial issues with processes ad supportig tools prior to their use i the real world. Addressig these issues prior to rollout elimiates their impact o iitial study teams, ultimately makig for a smoother rollout ad icreasig adoptio of EDC ad redesiged processes. CONCLUSION Obviously, the process of redesigig a cliical orgaizatio s operatios to effectively work with EDC is ot a easy oe. But cosiderig the alteratives iefficiet paper-based trials or poorly-executed EDC trial the decisio to udertake the redesig effort is a simple oe.

14 Realizig the Promise of Electroic Data Capture A Practical Guide PART 4: EFFECTIVE TESTING, TRAINING, AND ROLLOUT OF EDC SOLUTIONS OVERVIEW May orgaizatios that ivest i EDC systems ad related process chages still fail to achieve their expected beefits. Why? I may cases, EDC implemetatios fail at the very ed the testig, traiig ad rollout of the EDC solutio. Testig, traiig, ad rollout come at the ed of a log ad challegig implemetatio process. Ofte the staff members who are the primary drivers of the EDC project have bee workig o the effort for over a year, sometimes two years. By the time the EDC project has reached the fial stages, key team members may begi to be pulled away to other, high-priority iitiatives or simply lose iterest i the EDC iitiative. So, whe their eergy, kowledge, ad drive are eeded most, may of them are o loger available to see it through to a successful coclusio. Also, because these tasks occur at the ed of the implemetatio cycle, budget overrus earlier i the project are ofte extracted from the budget origially earmarked for testig, traiig, ad rollout. These ufortuate circumstaces are aalogous to movig a ball to withi feet of the goal lie ad the failig to score. Typically, orgaizatios that gai the greatest beefits from EDC are those that keep the project mometum strog ad preserve the budget ecessary to support these fial implemetatio steps. There are, of course, may other factors to cosider as well. This documet provides a five-step approach to streamlie the process of EDC testig, traiig, ad rollout icludig 1. Testig ad revisio 2. Approach to traiig 3. Traiig the cliical orgaizatio 4. Rollout to the cliical orgaizatio 5. Makig cotiuous improvemets TESTING, TRAINING, AND ROLLOUT PROCESS FOR EDC SOLUTIONS Step Oe: Testig ad Revisio For the purposes of this chapter, we focus o the testig of ew processes ad the fial acceptace of the EDC system by the users, usually called user acceptace testig. This testig deals with provig that the system ad processes are fit for their iteded use ad are coducted i additio to ay techical testig, which esures that the hardware ad software are fuctioig accordig to specificatio. Coferece Room Pilot Testig As discussed earlier i this book, the key to successful implemetatio of a EDC system is the developmet of revised work processes that take full advatage of the software by chagig fudametal assumptios about what, how, ad whe work is performed. If a effective process desig methodology is employed, the ewly desiged processes have a greater likelihood of success. However, the developmet of these processes is ever perfect. Testig is eeded to detect flaws before staff ad sites are traied o the ew work processes. This eed is further heighteed whe the developmet of the ew processes is broke ito segmets ad give to multiple teams. I these cases, the various segmets eed to be tested as a whole to fid poits of potetial redudacy or overlap. The best approach to testig the processes ad their iteractio with the software, is through a coferece room pilot. The goal of a coferece room pilot is to coduct a rapid but complete ruthrough of all the processes defied by the EDC project usig the actual software ad realistic test data. The most effective coferece room pilot tests are coducted with represetatives of the actual roles that are expected to complete the process. Preparatio The first set of decisios that must be made relates to the amout of effort ad risk that are acceptable. Testig is all about risk mitigatio. The primary reaso for testig is to reduce the risk that that a problem with that process is discovered after traiig, whe correctios are time cosumig ad costly to implemet. It is ot feasible from a timelie ad resource stadpoit to test every possible sceario that could occur after the system goes live. Therefore, the leaders resposible for testig eed to uderstad how much risk they are willig to assume. The authors experiece has show that valuable testig ca be codesed ito as little as oe week, focusig o the key processes ad work steps, or expaded to up to four weeks, coverig most major ad mior processes, as well as exceptio processes. To determie risk tolerace i this istace, a practical exercise is the best approach. Ofte the amout of risk willig to be assumed is expressed i terms of the amout of time ad resources the orgaizatio is willig to ivest i testig. Where the orgaizatio falls o that cotiuum (i.e., takig from oe week to four weeks for testig) is a statemet about its risk tolerace To prepare for the coferece room pilot test, a set of test scripts eed to be developed. Test scripts Figure 4.1: Steps i the Testig, Traiig, ad Rollout Process 1 Testig ad Selectig Traiig Revisio Approach 2 3 Traiig the 4 Rollig Out to 5 Makig Cliical the Cliical Orgaizatio Orgaizatio Cotiuous Improvemets

15 defie the testig sceario to be executed by the attedees. These scripts iclude backgroud o the specific situatio, lay out the work steps ecessary to complete the sceario, ad iclude ay data eeded to be etered ito the system. Test scripts are developed to match the overall scope of testig, ad they reflect the risk tolerace discussed earlier. Testig will oly be as effective as the test script, sice the attedees will oly cover what is icluded i the script. After establishig risk tolerace ad developig test scripts, maagig the logistics is the third most critical variable to the success of coferece room pilot tests. Attedees must be idetified ad time o their caledars must be made available o small task for such a itesive period of time. The most successful coferece room pilot tests iclude cross-fuctioal attedees, eve for sectios that are primarily drive by a sigle fuctio. By beig preset durig sessios where other fuctios hold primary resposibility, these cross-fuctioal attedees ca idetify issues that might affect their fuctioal area later. Such represetatives may iclude Study Maagers Data Maagers Cliical Study Moitors Idividuals from supportig processes, such as Safety, Biostatistics, or Regulatory I additio to coverig the key roles, the represetatives should also cross key geographic areas, especially if North America, Europe, ad/or Asia are plaig o usig the same processes. A sufficiet umber of attedees must be preset to be able to resolve issues that arise durig the meetig. A adequate meetig place must also be foud for the pilot ofte a large coferece room that ca be retaied for a exteded period of time. The selected site must be equipped with the techology eeded to utilize the system. Ofte coferece room pilot tests are more effective if multiple work statios are made available. Sice the pilot test is atteded by may staff members, a video projector ca be valuable to allow those ot i frot of termials to see the progress of testig. The attedees will also eed copies of both the process documetatio they will be followig ad the systems support documetatio. Executio of the Pilot Test Coferece room pilot tests require strog facilitatio, or they ca quickly degeerate ito a series of overlappig coversatios with little focus. The facilitator is resposible for trackig progress agaist the test scripts ad assigig a lead perso from amog the cross-fuctioal team members to execute each sectio of the test scripts. As issues are discovered, the facilitator determies if the issue ca be resolved quickly by the attedees. If so, the group cofers ad suggests a solutio. If the issue caot be resolved quickly, the facilitator assigs a sub-team of the attedees, ad if practical, the sub-team of attedees moves to a separate room to discuss a solutio. The subteam may eed to cotact others that are ot i attedace to gather additioal iformatio or get differet perspectives. The suggested solutios are documeted ad immediately tested. If the solutio is satisfactory, the process documets are updated to reflect the ew solutio. If the solutio is iadequate, the issue resolutio process cotiues. The facilitator is resposible for maagig the timelie ad avoidig delays. Fial Revisio Based o the results of the coferece room pilot test, the process documets may require a fial revisio. The fial revisio eeds to focus specifically o: Icorporatig fial chages Esurig that termiology, umberig systems, ad coectio poits betwee processes are used cosistetly The fial versio of the process documets eed to be siged off o by the testig team before traiig ca occur. User Acceptace Testig Each orgaizatio has its ow iteral defiitio of what comprises user acceptace testig (UAT). The authors defie UAT as the tests ecessary for the orgaizatio to have cofidece that the processes or systems beig tested are fit for their iteded purpose. Each EDC project team must meet with their iteral stadards-settig fuctio to determie what should be icluded i the UAT for their EDC implemetatio. I some orgaizatios, the scearios covered i the coferece room pilot test are cosidered adequate to support UAT. Other orgaizatios require specific

16 Realizig the Promise of Electroic Data Capture A Practical Guide structures ad approaches to UAT that are ot supported by the coferece room pilot test. The goal should be to complete as much of the UAT as possible simultaeously with the coferece room pilot test to avoid rework ad lost time. Step Two: Selectig the Traiig Approach The first step i developig a traiig program for EDC is to determie the optimal approach to traiig. The approach ca either be process-drive or role-drive. Each type of traiig has its advatages ad disadvatages, as discussed below. Process-drive traiig brigs together those staff members (roles) resposible for deliverig results at the ed of the EDC process to collectively lear how to execute the process. This type of traiig has the advatage of clearly defiig how traiees will work together to achieve the iteded results. This also helps establish lies of commuicatio amog various roles. The disadvatages of this traiig approach are the logistical difficulty of traiig staff who are ivolved i a rage of differet processes ad the iability to focus o the eeds of ay oe role durig traiig. Role-drive traiig breaks out each role ad reviews sectios of EDC processes that the role is expected to support. Role-drive traiig eables traiers to provide istructio o the updated roles ad resposibilities of a sigle positio. The traiig sessio(s) ca be staffed by their peers to help facilitate kowledge sharig. A focused, role-drive traiig sessio also elimiates the eed to sit through traiig aimed at other roles. However, while the role-drive approach keeps traiees focused o their idividual resposibilities, it ca be somewhat disjoited i that it oly covers certai parts of the process, some of which may ot be used util moths later. This approach also makes it difficult for traiees to uderstad how each work task cotributes to the ed result of the process. Determiig the appropriate traiig approach, process- or role-drive, is the first decisio that must be made prior to developig the traiig materials. The secod decisio is the delivery method. Delivery Traiig ca be delivered through various methods, icludig through live istructio, computer-based or prited learig materials, or a hybrid approach. The first ad most importat step to successful testig, traiig, ad rollout of EDC solutios is the orgaizatioal commitmet to apply the same eergy ad resources to the fial phases of the implemetatio that were applied to the iitial phases. Live istructor traiig i the stadard classroom settig usually cosists of oe or more istructors for each class of traiees. It may be provided faceto-face or through a shared electroic classroom usig software such as WebEx or LiveMeetig. This approach allows istructors to aswer questios o a ad hoc basis ad esures traiees are focused o the class cotet. Istructors ca also moitor the comprehesio level of traiees ad chage the pace of traiig appropriately. The challeges with this approach are the cost, i terms of both persoel time ad logistical costs, ad the scalability if a large umber of people require traiig i a short period of time. Materials traiig ivolves istructio either over the Iteret, via a software package, or through prited learig materials, typically cosistig of a traiig maual ad work book. This approach is efficiet ad requires either traier costs or the logistical costs of face-to-face meetigs; It also allows traiees to complete the course at their ow pace. However, it does ot allow for ay real-time iteractios for those who have questios ad makes it difficult to assess the traiee s level of egagemet or uderstadig. A hybrid approach employs some combiatio of the above types of traiig. A typical sceario for such a approach is face-to-face traiig at a ivestigators meetig ad electroic traiig for those ivestigators who caot atted the meetig. The logistics ivolved i this type of traiig, however, ca be cosiderable. Traiig Materials As a case example, let s use our recommedatio of role-drive traiig. Clearly, if traiig is goig to be electroic, the the approach for developig materials described below must also iclude the efforts associated with puttig those materials ito a traiig tool. Oce the traiig approach has bee selected, the materials ca be developed. Traiig materials should cosist of the followig: Traiig maual (orgaized by role) Ratioale for EDC implemetatio Overview of EDC processes Specific process traiig Discussio about supportig documetatio Discussio of additioal help Traier s maual (orgaized by role) Traiig maual orgaized by role Traier s support materials Developmet of the Traiig Maual Ratioale for EDC Everyoe traied should uderstad the expected beefits of EDC ad have a clear view of their part

17 i achievig those beefits. The explaatio of the expected beefits should be very brief ad focused o the specific future cotributio of the idividuals beig traied. Wheever possible, it should iclude how the beefit is beig measured ad how the traiees are expected to track results. Overview of EDC processes Each role beig traied is geerally oly resposible for a sub-set of the processes eeded to support EDC; however, it is importat to uderstad how that sub-set fits ito the overall process. The goal of explaiig the etire EDC process is to esure that every sub-set of processes is clearly liked to the fial results. This sectio ofte icludes a explaatio of the other roles ivolved i EDC processes, as well as istructio o how to read process diagrams. Specific process traiig At the heart of the traiig materials should be the process documetatio that was developed durig the process redesig phase of the implemetatio. The first step is determiig which processes ivolve the role beig traied. This sub-set of the process documetatio should be modified to highlight those work steps owed by the role beig traied. Discussio about supportig documetatio The process documetatio should also refer to ay support documetatio that aswers questios about why or how a certai step is completed. The discussio should iclude a descriptio of the support documetatio, a overview of the cotets, ad how to access the materials. Selected details from the supportig documets ca be icluded i the traiig sessio whe eeded to clarify a poit, but specifics such as these should be kept to a miimum due to the usual time costraits of a traiig sessio. Discussio of additioal help It is highly likely that traiees will eed two types of support followig traiig: 1. Techical support for usig the EDC ad related systems, icludig password maagemet ad hardware support 2. Process support for followig the processes defied i the traiig, icludig guidace o how to suggest improvemets to the existig processes Support systems must be put i place to meet both of these eeds. The systems may be built i multiple tiers, with simple issues hadled by local power users ad more complex issues hadled by cetrally located experts. How to access those support systems must be explaied at the ed of traiig. Support remider materials, such as stickers or magets with ames, phoe umbers, or websites, ca also be helpful. Developmet of the Traier s Maual I additio to the Traiig Maual discussed above, the Traier s Maual should iclude support materials that provide a explaatio of how to execute the traiig, icludig traiig logistics ad guidelies for a certificatio exam. Traiig logistics should be clearly described to esure that traiig is beig coducted ad documeted correctly. For example, a process for gatherig ames of attedees ad providig the attedees with credit for receivig traiig should be icluded. A set of otes should be developed to support the cosistet traiig of each role. These otes are usually developed o a page-by-page basis to accompay the Traiig Maual ad highlight the key poits that the traier should make whe providig the traiig. The details provided i the otes are related to the approach the orgaizatio is takig to traiig. If traiig is beig provided cetrally by experts, the otes ca be miimal. Alteratively, if traiig is beig provided i a cascade format with traiers that have limited subject expertise, the otes must be more robust ad complete. A certificatio exam, if relevat, should be icluded i the traiig materials. Some orgaizatios require a writte exam at the ed of traiig to ackowledge attedace or certify competece. The testig materials should be developed based o the type of certificatio goal ad the cotet of the Traiig Maual. The process for coductig the test ad gradig the tests should be clearly defied. If test results are ot immediately available, a explaatio should be provided about whe ad how the results will be available. Certificatio forms should be provided to the traiers for distributio to the traiees, as appropriate. Step Three: Traiig the Cliical Orgaizatio As the approach to traiig should have already bee decided, traiig executio cosists primarily of maagig the logistics of traiig. Campbell has foud that traiig is most effective whe provided withi two weeks (four weeks at the outside) of whe that traiig will begi to be applied. The challege, therefore, is to maage the logistics so that traiig occurs as close as possible to the time whe the traiees will begi usig the iformatio. If, for whatever reaso, there is a lapse of greater tha four weeks betwee the time of traiig ad whe the traiig is first applied, the orgaizatio should cosider providig refresher traiig just prior to whe the traiig will be applied. Step Four: Rollig Out to the Cliical Orgaizatio EDC systems are, by their ature, rolled out o a study-by-study basis, sice it is iefficiet to covert a study to EDC after it has bee lauched. For EDC system rollout, the first step is to idetify which studies are goig to be usig EDC ad the timelies associated with those studies. Usig this iformatio, a traiig schedule associated with those studies ca be developed to esure that the staff is prepared to leverage EDC. Traiig must begi well i advace of site activatio if the ecrf (electroic case report form) is to be developed i time for the study to go live. Besides traiig of iteral staff, aother key to successful rollout is the maagemet of the logistics ad traiig of each cliical site. Each site must have the proper equipmet to use the EDC system. While this equipmet varies by software, a set of stadards must be developed to judge the capabilities of the site s pre-existig software, hardware, ad commuicatios eviromet. Each site will eed to be judged agaist the stadards ad ay iadequacies idetified. The sposor or site must the remedy the iadequacies detected or the site will be excluded from the study. Each site participatig i the study will be required to have its staff certified o the EDC software ad will eed to be traied o how the use it.

18 Realizig the Promise of Electroic Data Capture A Practical Guide Site traiig ca be performed oe of three ways: 1. At the site by a sposor istructor, ofte the study moitor 2. At the site through electroic traiig 3. At a cetral locatio, ofte at a ivestigator meetig At the ed of traiig, each staff perso at the site who is certified is give the ability to access the EDC system. Each site will eed a set of istructios o how to request additioal support regardig hardware, software, commuicatios, or other issues cocerig the use of the EDC system. May orgaizatios use the cliical research associates as the first lie of support. Other orgaizatios leverage the same help desk set up to provide iteral support to the pharmaceutical or biotech compay. Step Five: Makig Cotiuous Improvemets Followig the rollout, the EDC system ad processes will be used i live study eviromets. It is ievitable that areas for improvemet will be idetified by those staff people ivolved i usig EDC. Areas for improvemet eed to be captured i a cetral locatio. May orgaizatios use their iteral help desks for this purpose. Other orgaizatios set up cetralized databases where suggestios ca be etered. A group of EDC power users must be made resposible for trackig these suggestios for improvemet ad determiig whe, if ever, some of the improvemets should be implemeted. This group will be resposible for developig a formal revisio schedule for updatig the EDC system ad processes. Typically, this schedule is o a yearly basis, although i the first year, a revisio may be completed after six moths. As suggestios for improvemet are made, they eed to be classified by the power users. Some recommedatios resolve critical errors or iadequacies i the curret approach to EDC. The suggested chage(s) to the curret approach must the be commuicated to the orgaizatio rapidly, ahead of ay formal revisio schedule. Other recommedatios iclude areas for improvemet that are beeficial but ot urget, ad should be held for the scheduled revisio cycle. Some either do ot beefit the etire orgaizatio or cotradict the policies or approach fudametal to the EDC system. These should be closed without actio. Regardless of the classificatio of recommedatios related to potetial improvemets, a ackowledgemet should be set to the staff perso who provided the suggestio to thak them for their iput. CONCLUSION The first ad most importat step to successful testig, traiig, ad rollout of EDC solutios is the orgaizatioal commitmet to apply the same eergy ad resources to the fial phases of the implemetatio that were applied to the iitial phases. A successful coclusio to the EDC implemetatio effort requires orgaizatio, plaig, ad resources. Those orgaizatios that ivest i those three areas achieve the greatest value for their total EDC implemetatio effort. 1A Approach to Bechmarkig EDC Performace: Results of a Feasibility Test. The EDC Forum. Jue Available at: Accessed o September 13, ABOUT THE AUTHORS Gary Tyso, Vice Presidet, Cliical Developmet Practice, Campbell Alliace Mr. Tyso leads Campbell Alliace s Cliical Developmet practice, which provides a rage of operatioal improvemet services to cliical developmet orgaizatios withi pharmaceutical ad biotech compaies, as well as leadig cotract research orgaizatios (CROs). Mr. Tyso is a vetera of umerous EDC-related iitiatives, ad he brigs a wealth of kowledge ad experiece i process improvemet, orgaizatioal desig, ad cliical developmet. Tim Dietli, Seior Practice Executive, Cliical Developmet Practice, Campbell Alliace Mr. Dietli is a key member of Campbell Alliace s Cliical Developmet practice. He focuses specifically o helpig cliets realize the beefits of EDC techology. I particular, he ad his team work with cliets to develop EDC strategies, avigate the vedor ladscape, ad redesig Cliical Developmet processes ad orgaizatioal structures to leverage ivestmets i EDC techology. ABOUT CAMPBELL ALLIANCE Campbell Alliace is the leadig maagemet cosultig firm specializig i the pharmaceutical ad biotechology idustry. The firm s cliets iclude most of the world s top 20 pharmaceutical compaies, as well as umerous emergig ad midsize firms. Campbell Alliace is orgaized ito practice areas, each specializig i a critical idustry fuctio, icludig Brad Maagemet, Busiess Developmet, Cliical Developmet, Maaged Markets, ad Sales. Cotact Iformatio: Gary Tyso: (919) , ext gtyso@campbellalliace.com Tim Dietli: (919) , ext tdietli@campbellalliace.com