Start-up Overview Detail

Each new start-up will cover the topics and issues below. In the text below, “Project” refers to a study or registry as appropriate. Please review the list in preparation for the start-up and contact us with any questions.

Main Topics


Subscription License

StudyTRAX uses a software as a service model. A single project license is based on the study design and planned enrollment.

  • Sample Size (i.e., Total planned enrollment)
  • Study design
    • Designs WITH a planned end to enrollment (i.e., Cross-sectional, Retrospective, Prospective).
    • Designs WITHOUT planned end to enrollment (i.e., Patient registry)
  • Pilot Data Grant Program and Student license available

Scaled licensing is also available for large deployments of StudyTRAX.


Support

ScienceTRAX provides top-notch support by staff motivated to ensure the success of your project. The standard StudyTRAX Service Level Agreement (SLA) for support will be applicable across projects (learn more). If applicable, a project may have a separate Service Level Agreement.


Training

Planning

StudyTRAX staff will be involved with all projects. Consideration of study training needs involves a number of factors, the main ones being project scope (e.g., how many people involved in setup and execution of protocol, number of sites, number of forms, data collection schedule, etc.), duration of project, complexity of procedures, and number of participants. In terms of planning and organizing training, there are three main components to consider:

  • What extent do you want to be involved? (e.g., building forms)
  • What are the needs of the various User Groups?
    • Users involved with setup and testing
    • Users involved in day-to-day operations of the research protocol (e.g., data entry staff, statistician, study coordinator)
    • Study participants (if applicable)
  • What are the effective training materials and delivery mechanisms?
    • Materials: Training videos, Standard Operating Procedures, “How To” text etc.
    • Delivery: Website, Workbench training Reports, internet meetings, etc.


Hosting

Hosting is included as part of the subscription license (with file size restrictions). A summary of security and hosting services can be found Learn more…


Subject Portal

Study participants can enter data online and use you also Push-Back reports to participants!! Reports are like a dynamic newsletter that can contain data and results, and data driven logic to build conditional text or any type of web-based content (e.g., video, podcasts, training materials) (See Examples). The Subject Portal may contain any number of secure or publically available webpages, and the look and feel is COMPLETELY up to you!! (See Examples).


Randomization

Randomization of study participants can be managed through StudyTRAX. In terms of organizing the use of this feature, the main components to consider are:

  • Configuration of feature (e.g., method selection, define groups, maximum enrollment, etc…)
  • User role assignment (e.g., who can randomize, who can view randomization groups, who is going interim data analysis, etc.)
  • Training users


Forms

The form designer supports nearly any imaginable form design, layout and validation requirements. In fact, anything that can be done on the web, can be done with StudyTRAX forms with little or no technical knowledge (See Examples). There is also a broad range of data types (e.g., dates, numbers, picklists, text, etc.). In terms of organizing the setup of forms, we’ll want to know if you prefer to learn and help create forms or if want everything done for you. Regarding the forms, the main issues to consider are:

  • The design and layout options that would best facilitate data entry.
  • If subjects to enter data, any special needs (e.g., sound, large fonts, etc.).
  • Plans to minimize data entry burden (e.g., variable defaults, calculated variables, data import, etc.).
  • Validation requirements (e.g., the data definition) and required fields.
  • If paper source, double data entry plans.
  • Data entry trigger events (e.g., send email if value entered into this field)


Concomitant Medications

ScienceTRAX will assist with the setup for the capture and reporting needs associated with concomitant medications. Depending on the requirements, this will be done using the standard approach to forms or using the integrated medication management tool. The cost covers additional training and setup-related tasks (e.g., building the forms, integration with data sets, subject medication list reports, etc.)

  • Determine best concomitant medication solution
  • Setup forms
  • Determine and address reporting needs, calculations, etc.


Study Web Site

StudyTRAX can be used to build and deploy any number of study-related websites. Websites can include an unlimited number of pages, both secure and public-facing, as well as any type of web-based content, layout, and navigational tools. The two most common websites are:

  • Study Website (See Example)
    • General study information (e.g., design, data collection schedule)
    • Standard Operating Procedures
    • Site names and description of how other sites can participate
    • Contact information
    • Training materials (e.g., video)
    • Adverse event report protocol
    • Other…
  • Participant Website
    • Information on how to participate in study
    • High-level infromation about the study, what to expect, screening criteria, etc.
    • Who to contact in case of adverse event or question
    • Compensation, directions, address, etc.
    • Other…


Data Collection

The data collection schedule can be configured to ensure the accurate execution of the protocol. Both planned and unplanned events can be handled. In terms of organizing what needs to be setup, the most important issues are:

  • The protocol schedule and associated forms (e.g., forms X, Y, and Z are collected at “Baseline”)
  • Study event triggers (e.g., send email/report if value above range entered, etc.)
  • The sites, user accounts and their associated roles
  • As applicable; the screening, enrollment and randomization logic


Adverse Events

In some cases, Adverse Event (AE) reporting is handled through a separate tool, often provided through the IRB. StudyTRAX can also be used to capture and report AE information, although the information is not automatically submitted to other applications. If StudyTRAX is to be used, adverse events are typically captured using a standard vocabulary (e.g., Common Terminology Criteria for Adverse Events; CTCAE). Related forms and reports will be set up accordingly (See Examples). Common tasks include:
.

  • Create AE and SAE forms
  • Setup trigger events (e.g., mails to study safety monitoring board)
  • Create subject and study-level reports


Reporting

StudyTRAX is built around the dissemination phase and thus there are a number of tools to facilitate the process of analyzing data and reporting results. Dissemination related needs are addressed at two different levels:

  • Subject Level (both within and across visits), examples include:
  • Study Level
    • Data sets (e.g., raw, transformed, or recoded data) for export to statistical package (i.e., SAS or SPSS) (See Example)
    • Canned StudyTRAX reports.
    • Custom StudyTRAX reports using the Workbench (See Example)
    • Examples…
      • Screening and enrollment reports
      • Data quality reports
      • Adverse event reports
      • IRB reports
      • Training material reports (See Example)


Custom Access Portals

In a similar fashion as study websites (see above), StudyTRAX can be used to build and deploy any number of study-related portals. Each portal can include an unlimited number of pages, both secure and public-facing, as well as any type of web-based content, layout, and navigational tools. A Data Safety Monitoring Board portal is the most common use, but any user-portal can be set up for various targetted users.


Other Features

There are a number of other features not specifically listed here that will be implemented as needed (e.g., double data entry). The specifics of your design will be covered during the start-up and will determine what needes to be set up. Our users drive our product roadmap, so give us feedback (here) and get involved (Get Started!!)!