How To Close A Study

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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 TrialKit:

   • 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 as contracted monthly fees are paid in accordance with the accepted terms.

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

   • This puts all data into a “read-only” state. 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. Once the study is set to “Completed,” it cannot be moved back to “Live”.

3. 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:

     • Data Extraction

       • 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

     • Queries Report

     • Audit History of events (optional step)

     • CRFs (PDF format)

     • Site/User Audit Report

     • Role Permissions Grid

4. Complete a Study Close Out Form, on which you will determine if CDS needs to archive or delete the study in TrialKit, as detailed in the Study Close Out Policy.