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TrialKit Drive Automated Exports

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TrialKit Drive

Allows Study Adminitrators to Schedule Exports to Run Daily or Weekly. The files can be pushed to one of the following 3 external destination points:

  • SFTP

  • Google cloud storage bucket

  • Google Drive

The data available for exporting are as follows:

  • Form Data with Medical Codes

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

  • Queries

  • Event Audit

  • Data Change Audit

  • Subject Status Information

  • Subject Visit Information

  • Site Progress Information

  • Sites and Users - A list of all users and roles on the corresponding study, along with other user-level data

  • 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 status on each field for all existing records

  • Wearables Data

  • File Repository

  • Record Status Report

  • 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.

To enable TrialKit Drive for an active study, submit a request to the support desk to initiate the setup

The following service account below will need to be given Writer or Contributor access within the cloud bucket or Drive location: clinicalstudio@trialkit.iam.gserviceaccount

Steps to setup Google Drive:

  1. Within a shared drive on a corporate (non-personal) account

  2. Create a folder

  3. Then share that folder with the TrialKit service account as a Contributor.

  4. Provide the folder URL to TrialKit support

Glossary of variables provided in the scheduled exports

Subject status

  • 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 Info

  • 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

  • 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

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