StudyTRAX and REDCap:

A Complementary Mix Of Academic Research Tools

Within academic institutions, the research innovation and productivity focus of StudyTRAX, and the no fee, basic functionality of REDCap are a compelling combination to 1) cover the board base of investigators that need an EDC tool, and 2) maximize the success of the most productive investigators. Indeed, this combination with varying deployment scenarios has become a common strategic approach to enhance an institution’s competitive advantage.

Determining The Best Fit

All EDC tools have pros and cons as it relates to 1) the needs of a specific study, 2) the career goals of an investigator, and 3) the institution’s strategic research informatics position. The following offers some practical steps, as well as issues to consider with regard to deciding the best fit.


Get Feedback From Users

Ask current users at your institution about their experience. Email support ( support@sciencetrax.com ) for a list of StudyTRAX users at your institution.

Suggested questions include:

  • What’s their overall impression?
  • Would they recommend its use?
  • How was the learning curve?
  • What happened when there was a question or an issue came up?
  • How was the support?
          
  • What was it like to:
           – Set up the study?
           – Query data and generate reports?
           – Extract and analyze data, and publish the results?

  • Dissemination Plans And Support

    In “Big-Picture” terms, features and customer support are the main distinction between StudyTRAX and REDCap. In terms of features, nearly everything that can be done in REDCap can be done in StudyTRAX. However, common features between the applications are much more mature and sophisticated in StudyTRAX, and the unique features found only in StudyTRAX target the analytical and dissemination phase. Thus, if your needs are primarily data storage related, then leaning toward REDCap is more reasonable. However, StudyTRAX is the best choice if your focus is on data storage, PLUS the analysis and transformation of that data into information, and it’s automated delivery to the following targeted stake-holders:

    1. Subjects (patients)
      • Dynamic reports and educational materials directly driven by the subject’s own data (learn more, full circle ePRO)
    2. Research or Clinical Staff
      • Automated clinic notes (e.g., data and logic driven text, color coded clinic metrics over time) and study reports (e.g., severe adverse events, safety monitoring)
    3. Academic Community
      • Complete integration of the process of generating all types of academic output (e.g., manuscripts, posters) or administative reports (e.g., enrollment numbers across all studies within a Department)

    Regarding customer support, REDCap support varies by institution, but is typically a shared effort with no one person is responsible, and getting up and running with REDCap is largely an independent learning experience. StudyTRAX support is second to none and is consistently delivered through ScienceTRAX by building trusted, long term relationships with customers. StudyTRAX users are assisted through the entire process and questions are answered from within a few minutes to hours. Much more could be said about our support, but best to ask any StudyTRAX user.


    Look Along A Continuum

    Consider where you fall along the continuum for each item listed below. In general, the more your responses lean to the left, RedCAP is a better fit, and the more your responses lean to the right, StudyTRAX is the best fit.

    RedCap_StudyTRAX

    Changes to the database
    Changes to production database requiring approval by administrator. Questionmark Want full independent control of database content and immediate effect of changes (or full versioning).

    Training, start-up and transformation of data into information
    Pointed to training materials and a largely independent learning experience. Questionmark Assigned specific support person, learn via direct interaction with staff using your project as the basis. End-to-end assistance: from set up to reporting / publishing.

    Funding resources
    Varies by Institution
    License cost between $0 to $500.
    Setup costs average between $80 -$90/hr.
    Questionmark Funds available to purchase license
    (or student [nominal student license fee])

    Application Accountability
    Shared approach, no one person / group responsible for code base. Questionmark Want to know who specifically to go to if question, suggestion or problem to address.

    Support Staff Contingencies
    Support is a shared effort (no one person responsible), and support effort not tied to reward or success / failure of product.
    Varies somewhat by institution.
    Questionmark Support staff with contingencies of having to do a good job to stay in business and support effort directly tied to reward and product success.

    User-interface design (see pictures comparig UI below)
    Focus primarily on functionality
    (i.e., text-heavy user-interface involving mostly boxed lists of actions, limited workflow organization).
    Questionmark Usability considered equally important as functionality, user-interface captures entire workflow from setting-up and running a study, to the publication of results.

    StudyTRAX vs. REDCap User-Interface Comparison: Performing the Same Task – Electronic Signatures


    If Starting A Patient Registry: Additional Considerations

    If you are starting a patient registry, the following are additional considerations for determining whether RedCAP or StudyTRAX is the best fit.

    RedCap_StudyTRAX

    Data collection and dissemination plans
    Mainly to capture basic data, only one or two analyses planned. Questionmark Capture rich, multi-source data sets. Plans for iterative, sequential hypothesis driven examination of data and associated academic output
    (e.g., manuscripts, posters, etc.).

    Data utilization plans
    No plans to leverage data on a day-to-day basis within clinic. Instead, intermittent big-picture analysis here-and-there. Questionmark Data to be tightly integrated with “real-time” decision making and note generation
    (e.g., automated clinic notes).

    Data sharing plans
    No plans to share or combine data with other studies or registries. Questionmark Want centralized registry, ability to share and integrate data, forms, reports, etc. with other studies / registries.

    Patient Portal
    No plans for patients to enter data online
    (i.e., in clinic or at home).
    Questionmark Want integration of patient entered data, and/or delivery of data driven reports and/or educational materials to patients.

    Consider the Development Path

    StudyTRAX and RedCAP started development at about the same time. Compare the beadth and innovative nature of their current feature sets. Now project out this same development path over the next five years. Taking the time to learn and leverage an EDC tool is an important career decision with regard to overall research productivity, the breadth of methodological designs that can be deployed and the functionality to remain at the leading edge of an increasingly competitive research landscape. Consider what tool best positions you for achievement of your career aims.


    Key Features That RULE OUT StudyTRAX

    • Create forms by entering the variable definition into excel (e.g., row 1: column A = “Sex”, column B = “male”, etc.)
    • Assign specific forms to users for data entry
    • Treatment arm schedules that vary across groups
    • Assigning a specific date to a study event for a study participant (e.g., the “Month 1” visit will occur on DATE for subject X)

    Key Features That RULE OUT RedCAP

    • Assign specific forms to subjects for data entry
    • Randomization (various methods) and all associated roles (e.g., Pharmacist role for dispensing study medication)
    • Medication management and tracking
        – Central list of medications
        – Medication entered once for subject and information available across studies as applicable
        – Dose equivalency calculator integrated into data sets
    • Form Design
        – Electronic forms that look like the paper forms
        – Forms that fully leverage the web (e.g., multi-media tools, sound, video, slider control, images, etc.)
    • Automated generation of subject Reference ID or Study ID
    • Double data entry with independent primary / secondary roles
    • Automated subject-level report generator for:
        – Clinic notes
        – Study reports (e.g., serious adverse events)
        – Invoices
        – Other…
    • Complete integration of manuscript / report generation process
    • Queries and associated roles and reports
    • Data Set Functionality
        – Calculated and recoded variables in data sets
        – Integrated data consolidation routines (e.g., grab data from the “First” and “Last” clinic visit for everyone in the data set)
        – Build charts and tables directly from data sets, dynamically update
    • Subject portal
        – Data entry using forms the fully leverage the web (e.g., multimedia tools, video, sound, etc.)
        – Automated delivery of reports / educational materials to subjects dynamically linked to their specific data.
    • Skip logic within and across variables or entire forms (complete utilization of javascript and HTML if wanting to move beyond built in wizard)
    • Integrate and combine data across more than one study or patient registry
    • Off-line data entry (export / import an entire project)
    • Logic driven form completion status (as opposed to manually set completion status)
    • Integrated manuscript / report generator, across one or more studies
    • Ability to create forms that capture protocol information (e.g., budget form, PI name, start date, etc.)
    • Centralized calendar across studies
    • Integrated System Administration tools for IT staff