TrialKit Drive
Allows Study Adminitrators to Schedule Exports to Run Daily or Weekly to an SFTP or Cloud bucket. Those export options are listed below.
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 Consented 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
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
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 this form
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.
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