Study Closeout Policy

Policy Effective Date: April 24, 2020

TrialKit provides the ability for CDS clients (“Clients”) to lock and close down a study database upon completion of their study. The two primary steps in doing are:

  • Electing to export, archive, or delete all study data
  • Cancelling, extending or adjusting the previously contracted Software License Agreement (SLA)

     

The following steps outline 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 Client 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, however, this status is reversible by the Client at this point, similar to the “Locked” status. Existing data may be viewed, but not modified, within the study database. Study access through TrialKit, along with the monthly license fee, will continue until the Client has submitted a completed Study Closeout Form.

  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 is explained in more detail in the following TrialKit online help sections:

  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 Closeout Form to be provided by CDS, as detailed below. Client must notify CDS and select one of the following options within 30 days of the study status being changed to “Completed”:

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

  • If Client elects to extend a completed study, 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. Client will maintain access to the completed study for viewing, reporting, and analysis for as long as fees continue to be paid and remain current.
  • The previously contracted fee will be reduced by 75% starting in the next full month following Client’s submission of a Study Closeout Form selecting this option. 
  • 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

  • If Client elects to archive a completed 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.
  • CDS will invoice Client annually and Client must pay the annual fee within 30 days of the date of the invoice.
  • Study will remain visible to users, however, study data will no longer be accessible. 
  • Unless Client notifies CDS in writing with at least 30 days’ prior notice of Client’s desire to delete the study, annual archiving fees will automatically renew on the anniversary date indicated on the Study Closeout Form.

 Delete Study

  • If Client elects to delete a completed or archived study, CDS will present Client with a Study Closeout Form, and Client will select the “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 or accessible to Client.
  • IMPORTANT NOTE: 
    • Emergency recovery of the study may be possible for up to 180 days from date of study deletion as indicated on Study Closeout Form, however, a $7500 recovery fee will apply. 
    • Upon expiration of 180 days from the date of the study deletion request indicated on the Study Closeout Form, the study will no longer be recoverable.

 

NOTE: If Client fails to fully execute a Study Closeout Form within 30 calendar days of changing the study’s status to “Completed”, regular monthly invoicing will continue at the previously contracted rate, with payment due within 30 days of invoice date.