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:
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Form Data with Medical Codes
- Non-subject form data (site and study form data)
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Queries
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Event Audit
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Data Change Audit
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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
Consented
Cohort Name
Cohort ID
Study exit date
Reason for study exit
- Subject ID
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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
- Subject ID
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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
- Site Name
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Sites and Users - A list of all users across all sites and information specific to those users
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Data Dictionaries - All the details about how forms are designed for data collection
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Site Payments - Payments that are due or paid for all records in the study
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Field Source Verification - Field SDV statuses
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Wearables Data
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File Repository
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Record Status Report
- Site Name
Subject ID
Registration Date
Visit Name
Low Window
High Window
Form Name
Form required
Record status
Visit Date
TransID
Status
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
- Site Name
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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.
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Site activation and first enrolled subject
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Enrollments over time
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Overall planned study timeline and where the site/patient recruitment is at along the timeline
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Randomization over time
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Deviations by time and site
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Adverse Events split into serious and non-serious
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Open queries to the site’s attention by age
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Manually Issued queries by age
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Required vs Missing CRFs
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Time to data entry from target visit date
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Pages monitored over time by the site
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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.