Clinical Trial

Owned by john Putzke
Last updated: Feb 14, 2017

Getting Up And Running!!

StudyTRAX has a number of sophisticated features designed to ensure an efficient setup and study execution process. This website is designed as a big-picture guide to clinical trials in StudyTRAX. Please send any questions or feedback to support ( support@sciencetrax.com).
 

Clinical Trial Setup

Case Report Forms.

The first step in setting up a clinical trial is form development.

  • Key Features
    1. The form designer supports nearly all imaginable CRF layout and design requirements. In fact, anything that can be done on the web, can be done with StudyTRAX forms. For more details, review the form building website.
      • Form Design
  • Examples
    1. Multi-media data entry with video, sounds, pictures, etc.
    2. Data entry forms with extensive validation routines (e.g., skip logic, etc.)
    3. Form that integrates data entry with clicking on an image, or a form with a background image with data entry field positions designed accordingly (e.g., image of person, and left lower leg pain field entered over that part of the picture).
  • What To Consider
    1. What form design and layout options best facilitate data entry?
    2. Will subject enter data? If so, are there any special needs (e.g., sound, large fonts, etc.)
    3. How can the data burden be minimized (e.g., variable defaults, calculated variables, etc.)?
    4. What data fields, if any, are required?
    5. Will there be a paper source? If so, will data be double data entered?
    6. Be sure to import and leverage existing forms already set up on your system and the StudyTRAX Sharing Forms website
Data Collection Schedule

Matching up the forms (CRFs) with the data collection schedule (i.e., what forms are collected when?).

  • Key Features
    1. Flexible subject encounter / visit setup and types
      • Fixed (e.g., Year 1) and non-fixed (e.g., adverse event) subject encounters
      • Target length (applicable for fixed encounters only) and encounter due range (i.e., days, weeks, months, years)
      • Assign forms to encounters (i.e., what forms are collected with what encounter) and subjects (i.e., what forms are filled out by subjects?)
    2. Screening encounters
  • Examples
    1. Multi-arm trials
    2. Unscheduled visits
    3. Automated emails going out to subjects for data entry at various schedule time intervals
  • What To Consider
    1. Will the treatment arms differ between groups?
    2. Will the forms collected vary by group assignment or subject characteristics (e.g., prostate questions only for males)
    3. What are the inclusion / exclusion criteria?
Randomization

Determining group assignment.

  • Key Features
    1. Several randomization methods
      • Simple
      • Permuted block, single block size or randomly selected multiple block sizes
      • Stratified permuted block
    2. Supports any number of groups
    3. Multiple blinding methods (e.g., single, double, etc.)
    4. Separate randomization user role
    5. Separate view randomization assignment role (e.g., pharmacist role)
    6. Flexible screening validation design, completely configurable
  • Examples
    1. Simple randomization into three groups with a weighting of 20%, 20%, 60%, respectively
    2. Stratified permuted blocks that includes the site as a blocking variable
    3. Centralized randomization done only by the data organizing center, or distributed randomization done at the site level
  • What To Consider
    1. What randomization method will be used?
    2. Who can randomize a subject and who can access / un-blind randomization?
    3. What are the practical mechanics involved in randomizing a subject?
    4. How will subjects be screened (e.g., inclusion/exclusion criteria, run-in period design)?
Leveraging the Subject Portal

Determine whether subjects will enter data or not, and/or be delivered reports or educational materials dynamically linked to their data.

  • Key Features
    1. Subject data entry
    2. Subject Reports (i.e., deliver information to subjects)
  • Examples
    1. Multi-media data entry with video, sounds, pictures, etc.
    2. Data entry forms with extensive validation routines (e.g., skip logic, etc.)
    3. Report of participation points (e.g., provide total points score based on number of forms completed and the points, in turn, can be redeemed for items of interest).
  • What To Consider
    1. What proportion of targeted cohort is able to use / access a computer?
    2. What information could a patient provide that would facilitate or improve the research process?
    3. What data-driven information would be helpful for subjects / patients?
      • What materials need to be created (e.g., a pdf file with a disease overview or dietary recommendations, list of support groups) vs. will be entirely driven by data (e.g., mean systolic blood pressure over time)?
      • What data-driven clinical events will trigger specific information (e.g., if BMI over 25, show video on weight management)?
Reporting Requirements

Automating the reporting process.

  • Key Features
    1. Subject-level reports, within or across visits.
      • Serious adverse event reports
      • Scheduled events summary (e.g., expected dates, due range, etc.)
    2. Group-level reports dynamically linked to data (see Workbench for details)
      • Comparative group charts, tables, and graphs
      • Overall reports (e.g., enrollment and screening reports)
  • Examples
    1. Serious Adverse Event reports, single subject and group level
    2. Planned charts, tables, graphs, etc. for Study Safety Monitoring Board, completely configurable and instantly updated as needed
    3. IRB reports
  • What To Consider
    1. What are the reporting requirements for the study?
    2. What reports can be automatically generated using the integrated subject-level clinic note generator or group-level Workbench area?
    3. What other reports would help facilitate study execution and ensure accurate data collection?
Training

How to ensure all sites are trained.

  • Key Features
    1. StudyTRAX training website.
    2. Custom training website / reports
    3. Web-based meetings
  • Examples
    1. Standardized email to all new users regarding the training website with associated links
    2. Web-based meeting covering subject enrollment and data capture
    3. Training videos covering needed areas (see here)
  • What To Consider
    1. What level of training is required, estimated training time?
    2. Should training be consolidated into a centralized website?