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How To Close A Study

Preparing for and Closing a Study

The following outlines the steps required to properly close out a single study in TrialKit.

NOTE: Your company's processes and procedures may include tasks other than what is listed here, these are recommendations.

After all internal data management, clinical, and site tasks (as defined by your organization) are completed, the following steps should be taken prior to closing a study. 

  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 in the study database may be viewed, but not modified. 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:

Study Close Out Form

The last task is to 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.

Note: Crucial Data Solutions requires a 30-day notice to close out a study database once the signed Study Closeout Form is received.