TrialKit Drive and Business Intelligence (BI)

TrialKit Drive Allows Study Managers to Access all Data and Metrics from a Single Location and Schedule Those Exports to Run Daily or Weekly to an SFTP

TrialKit Drive is a cost-effective option for users who need convenient single-point access to all data and performance metrics for their own storage or report-building purposes. The following reports are provided:

  • Form Data with Medical Codes

  • Non-subject form data (site and study form data)
  • Queries

  • Event Audit

  • Data Change Audit

  • Subject Status Information

    • Subject ID
      System subject ID
      Number of CRFs required
      Required Records Entered
      Adverse Events
      Enrollment date
      Subject randomized
      Randomization group
      Randomization Date
      Cohort Name
      Cohort ID
      Study exit date
      Reason for study exit

  • Subject Visit Information

    • Subject ID
      System Subject ID
      Visit Name
      Visit Interval sequence
      Visit Interval ID
      Cohort ID
      Cohort Name
      Target Visit Date
      Visit window low date
      Visit window high date
      Visit Status
      Number of Missing forms
      Number of entered incomplete forms
      Number of forms not yet entered 
      Visit Missed
      Visit In Window and awaiting data
      Visit In Window and started
      Visit upcoming in 30 days or less
  • Site Progress Information 

    • Site Name
      Enrollment goal
      Number subjects enrolled
      Forms completed
      CRFs Monitored
      CRFs Signed (review completed)
      Total open queries
      Total manual queries
      Number of Open manual queries
      Number of Open system queries
      Number subjects Randomized
      Total Number of Adverse Events
      Number of AEs based on a user-defined variable
      Number Deviations
  • Sites and Users - A list of all users across all sites and information specific to those users

  • Data Dictionaries - All the details about how forms are designed for data collection

  • Site Payments - Payments that are due or paid for all records in the study

  • Field Source Verification - Field SDV statuses

  • Wearables Data

  • File Repository

  • Record Status Report

    • Site Name
      Subject ID
      Registration Date
      Visit Name
      Low Window
      High Window
      Form Name
      Form required
      Record status
      Visit Date
      Days Missing
      Record ID
      Date Created
      User Who Created
      Date Last updated
      User who updated
      # Locked Fields
      # Queries
      Review 1 date
      Review 1 user
      Review 2 date
      Review 2 users

  • Product Inventory (coming soon)

Similar to the manual data exports, TrialKit Drive will enforce data blinding based on a pre-determined study role. Keep this in mind if the study involves any blinding.

Please inquire with your Account Representative for a comprehensive glossary of data variables provided directly in TrialKit Drive.

To enable TrialKit Drive for an active study, please fill out the form below:

TrialKit BI

With the addition of TrialKit BI, the data can be pushed to a central data repository, or data warehouse, to produce highly valuable visual reports for important business decisions. This can even work across multiple studies - both from TrialKit and other sources.

The following are examples of the type of visual and interactive reports readily-available by TrialKit BI. 

  • Site activation and first enrolled subject 

  • Enrollments over time 

  • Overall planned study timeline and where the site/patient recruitment is at along the timeline

  • Randomization over time 

  • Deviations by time and site 

  • Adverse Events split into serious and non-serious

  • Open queries to the site’s attention by age

  • Manually Issued queries by age

  • Required vs Missing CRFs

  • Time to data entry from target visit date

  • Pages monitored over time by the site

  • Pages signed/locked over time by the site

There are virtually no limitations to visual representations and information available regarding study performance and data collection.

Please inquire with your Account Representative to learn more about this tool and how it can be implemented to give you the near-real-time reporting needed to address the various challenges in conducting research.

Below is an example of a report which is both interactive and downloadable as a data listing to users with direct access.