Study Closeout Policy

TrialKit provides the ability for users to lock and close down a study database upon completion of their study. The two primary steps in doing so involve the users:

  • Exporting and/or archiving all study data

  • Cancelling, extending or adjusting the previously contracted Study License Agreement (SLA)

The following steps outline all the steps required to properly close out a single study in TrialKit:

  1. Change study status to “Locked” (aka “Soft Lock”) in CDS Platform:

When a study is locked, no new data beyond the date of lock can be entered, however the “Locked” status is reversible by the User at this point. Existing data can still be modified and reviewed and the TrialKit database provides full accessibility to the study as long contracted monthly fees are paid in accordance with the accepted terms.

  1. Change study status to “Completed” (aka "DB Lock or Hard Lock”)

This puts all data into a "read-only" state with the study database still accessible, however, this status is reversible, similar to the “Locked” status. Study access through TrialKit, along with the monthly license fee, will continue until the last day of month following the date that the study status was changed to “Completed”. 

  1. Export data

Primary data and metadata can be exported in four common areas: Data extraction, queries, audit history, and PDF subject casebooks. Extracting data in each of these areas are explained in more detail in the following TrialKit online help sections:

  1. Data Extraction

    1. Along with data extraction, it is common to export the Annotated CRFs or Data Dictionary for the study.  These help users determine which columns will appear in the data extracts

  2. Queries Report

  3. Audit History of events (optional step)

  4. CRFs (PDF format)

  1. Determine if CDS needs to extend, archive or delete Client’s study in TrialKit. Client’s selection will need to be confirmed through the completion of a Study Closure Form to be provided by CDS (see detailed options below).

Client must notify CDS and select one of the following options within 45 days of the study status being changed to “Completed”:

 Extend Study in “Completed” status for 25% of the Previous Monthly Fee

      • As of the last day of the next full month following move to “Completed” status, the monthly fee is reduced by 75% while allowing Client to maintain access to the completed study for viewing, reporting and analysis for as long as monthly fees continue to be paid and remain current.

      • CDS will present Client with a Study Closeout Form reflecting the agreement to extend the study at a revised monthly fee equal to 25% of the previously contracted  monthly fee.

      • At any point, should Client wish to modify their access to TrialKit, CDS requires 30 days’ notice to archive or delete the study (see options below).

 Archive Study

      • CDS will present Client with a Study Closeout Form reflecting the agreement to archive the study at an annual rate of $1100/yr.

      • Study status will be changed to “Archived” by CDS and stored on the CDS server

      • Upon receipt of signed SLA, CDS will invoice Client accordingly and change the study status to “Archived”

      • Study will remain visible to users, however, no study data will no longer be accessible. 

      • Unless otherwise notified in writing with at least 30 days’ notice, annual archiving fees will automatically renew on the anniversary date indicated on the Study Closeout Form.

 Delete Study

      • CDS will present Client with a Study Closeout Form and Client will select “Delete Study” option confirming Client’s agreement to request that CDS delete the study at no cost

      • CDS will completely remove and permanently delete the TrialKit study data and database from the CDS server.

      • Study will no longer be visible nor accessible to Client

      • IMPORTANT NOTE: 

      • Emergency recovery is possible for up to 180 days from date of study deletion selection as indicated on Study Closeout Form, however, a $7500 recovery fee will apply 

      • Upon expiration of 180 days from date of study deletion request indicated on Study Closeout Form, the study will no longer be recoverable


NOTE: If Client fails to fully execute a Study Closure form within 60 calendar days of the study’s status changing to "Completed", regular monthly invoicing will continue at the previously contracted rate, payable Net 30.