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Clinical Research Challenges and Solutions: The “What If?” SeriesA Simple Challenge, a Daily Pain:                 investi...
Clinical Research Challenges and Solutions: The “What If?” Series       Fig 2: Number of Studies per Participant        sy...
Clinical Research Challenges and Solutions: The “What If?” SeriesStudy personnel use multiple methods, often              ...
Clinical Research Challenges and Solutions: The “What If?” Series            Figure 7: Work Station Used        3. Direct ...
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Clinical Research Challenges And Solutions “What If ”- Nov 2012


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A Simple Challenge, a Daily Pain: Managing URLs and Passwords.

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Clinical Research Challenges And Solutions “What If ”- Nov 2012

  1. 1. Clinical Research Challenges and Solutions: The “What If?” SeriesA Simple Challenge, a Daily Pain: investigators (PI), while 25% stated that theyManaging URLs and Passwords. had “other” roles. This sample appears to represent well the various functions that are necessary to perform the necessary clinicalP-A. de Lame MD 1, M. Lemaire MD 2, J research functions.Boily MBA 3What if? Fig 1: ParticipantsYou could place all your secure websites 40%links and passwords in a single place, secureand accessible on the web from anywhere? 37.50% 30%What’s the need?The shift from paper-based operations to an 25.00% 20%electronic environment has brought some 18.80%real practical challenges to the studycoordinators. These challenges are usually 10% 12.50%12.50%not discussed in journals dedicated to clinicaltrials or to bio-IT. Besides the expected 6.30%training, data entry and data management 0%work that electronic data capture (EDC) SC SM PI PM DM Othersystem require, personnel also is required tocomply with strict access control processes, Scope of the Issuewhich differ from system to system, sponsorto sponsor, and even, from study to study. The issue really comes from theThis is true also for other systems that study multiplication of secure web sites and ofpersonnel use, such as study portals, credentials that study personnel has to useelectronic medical records, and scheduling on a daily basis. Indeed, managing thesystems. multiple web sites as a single study may require remains manageable to an extentExperience shows that remembering all the even though accessing these many systemsaddresses (URLs) and the corresponding can be sometimes challenging. However,credentials (usernames and passwords) is a most study sites are involved in severalreal practical challenge for which few good studies at any given time (figure 2).solutions exist, if any. As a companydedicated to addressing real-life problemsfaced by research personnel, XeoTKendeavored to explore the issue further.How Does Study Personnel Cope?In a survey performed in October andNovember 2010, XeoTK asked various studypersonnel what their primary role was. Mostparticipants (figure 1) were studycoordinators (SC), site monitors (SM), projectmanagers (PM), data managers (DM), and ! Page 1
  2. 2. Clinical Research Challenges and Solutions: The “What If?” Series Fig 2: Number of Studies per Participant systems that they are using on a very regular50% basis. 50.00% Fig 4: Passwords per Participant38% 50% 37.50% 50.00%25% 40%13% 30% 12.50% 31.30% 0% 20% 2-4 5-10 5-10 18.80%According to XeoTK’s survey, eighty-seven 10%percent of the respondents were involved in 2to 10 studies. For each study, participantsstated that they needed to access between 2 0%and 10 secure web sites (figure 3). 1-5 6-15 16-25 Fig 3: Web Sites per Study Because studies from multiple sponsors and 50% various institutions require using systems 50.00% supported by many independent entities, no single place exists where access to these 38% multiple systems and the corresponding credentials is made easy, safe and secure. 31.30% To put the matter in perspective, clinical 25% research is now making extended use of information technology regardless of whether EDC/RDC is actually used. Most information 13% 12.50% and/or communications necessary to execute clinical trials such as study documents, IRB 6.30% submissions, health records, lab data, reside 0% 1 2-4 5-10 >10 on separate systems, each of them accessible on a different website andCompounding Factors requiring secure login. Study meetings are increasingly virtual too. Since most studyConsidering that there is no coordination coordinators work simultaneously on differentamong the various sponsors and CROs who studies, the problem is compounded by themanage these web sites, it comes to no multiple sponsors and CROs, their specificsurprise that study personnel has to manage study portals and preferred EDC/RDCa multitude of usernames and passwords, systems, in addition to the systems put forthbesides having to remember the correct by IRBs, and core laboratories. The result: aaddresses (URLs) for the various portals and study coordinator needs to remember onEDC/RDC systems. The result is obvious: average 5-10 different credentials and webstudy personnel, just to do their jobs, have to site addresses per study.use a variety of web addresses andcredentials, most often between 6 and 15, Managing Passwordssometimes many more (figure 4). Some How do study coordinators usually manageparticipants reported having to use well over remembering their secure login information?50 sets of credentials to access the various ! Page 2
  3. 3. Clinical Research Challenges and Solutions: The “What If?” SeriesStudy personnel use multiple methods, often computer industry standards that requiresimultaneously, to keep track of their screens to take less than 2 seconds tocredentials. Post-It notes, note books, refresh from one to the next. Small gains incomputer files, and emails are popular (figure time to access may not means much at first5). And when memory fails, the “retrieve my sight. However, as users have to switch frompassword” function is a surprisingly often one system to the other, or login severalused last resort option (12.5%). times as sessions expired, the small gains may accumulate into significant time savings Fig 5: Methods Used to Retrieve Credentials at the end of the day, as well as much60% decreased stress and frustration. 56.30% Fig 6: Speed of Access50% 60%40% 56.30% 37.50%30% 31.30% 40%20% 18.80%10% 12.50% 25.00% 0% 20% Note Computer 18.80% Post-It Book File Email MemoryNone of these methods is actually safe.Indeed, the credentials can be lost andfound, seen or stolen with the associated risk 0%of being then misused. Most importantly, Always Sometimes Often tooeven if not misused, lost credentials quick, longer long andinvalidate the associated electronic easy than expected frustratingsignatures that are critical to many systemsused in clinical research, thus requiringgenerating new credentials, a time-consuming process. Multiple WorkstationsNone of these methods is efficient either. To Another aspect that affects the efficiency ofaccess a given web site, one needs to type in these methods is that, if they hosted on athe correct address (URL), then the computer (as files or applications), they arecredentials, which have to be retrieved first. not portable. That means that about 1/3 ofThis leads to time wasted on processes that the respondents have to use alternativeif streamlined, should be transparent means (not computer-bound) of keeping(preferably) or at the least, very easy. The track of their credentials as they use anyexperience reported in our survey illustrates computer that is available at work (figure 7),the point (figure 6). a trend that is expected to grow with the increasing use of information systems inImportantly, the experience of the users is medical practice, including the expanding usereported on a perceptual basis, as opposed of electronic medical records. This isto absolute measures of time and motion. reflected in figure 7, which depicts what workThus, it is not clear from this survey whether stations our participants use to access the“always quick and easy” corresponds to various web sites from. ! Page 3
  4. 4. Clinical Research Challenges and Solutions: The “What If?” Series Figure 7: Work Station Used 3. Direct data entry using an assigned work70% computer 68.80% 4. Direct data entry using any computer 5. “Not applicable” corresponds to 18.8% of the participants who are not involved in any data entry activities. Figure 8: Data Entry35% 50.00% 50.00% 31.30% 37.50% 25.00% 0% 18.80% Work / home Any available 12.50% 12.50% computer computer 0%Managing Data Capture 1 2 3 4 5As electronic signatures are particularlycritical to EDC/RDC, the XeoTK survey morespecifically inquired about the methods used In summaryby personnel involved in data entry toperform this task. Current methods used by study personnel to manage secure login information present aThe results shown in figure 8 confirm that serious problem, because, by lacking securityvery often, any available computer is used. and efficiency, they essentially defeat theThey also show that, even though EDC/RDC methods aimed at protecting the system usedaims at being paperless, worksheets are on clinical research, and the data that theyused by the majority of the participants host. However, we cannot blame studyconcerned. personnel for trying to address the problem with the means that are at hand. CurrentThis figure also suggests that multiple technologies allow for much better solutionsmethods may be used by the same that provide secure, mobile, fast and easypersonnel, probably depending on studies access to critically important web sites.are set up, study requirements, and how userfriendly systems are.The key to the methods shown on the X-axisis as follows: 1,2,3: XeoTK, Inc., Lambertville, NJ 08530 ( Capturing data on a worksheet, then entering using an assigned work XeoTK™ is developing OneKey™ which allows clinical computer research professionals who routinely manage, secure, and access website links and passwords, anytime and anywhere to perform their work without compromising any existing2. Capturing data on a worksheet, then electronic signatures. entering using any computer XeoTK, OneKey and the XeoTK logo are trademarks of XeoTK Inc. ! Page 4