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 may include tasks other than what is listed here. These are only recommendations based on what is typically done.
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”)
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. Export Primary Data
Subject data extraction - Be sure to do this separately for each version of the study that subjects reside on:
Site and Study data (if applicable)
- CSV Data
- Site and Study data entry audits
3. Export Supplemental Data
Along with data extraction, it is helpful to export several other components for future reference:
Consent report (if applicable for the study)
4. 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”. Do not move the study to "Completed" until all study activities (including data exports) are completed.
5. Fill out a Study Close Out Request in Accordance With the Study Closeout Policy
- A Study Close Out Request must be completed and received by CDS before any Customer's request to delete or archive a TrialKit study can be initiated.
- Once the request is received by CDS, a formal Study Closeout Form will be sent to the Customer for review, approval, and signature. This signature grants CDS the required approval to schedule, close, and either delete or archive the study on the date agreed to in the form (typically the last day of the month after the 30-day notice has been fulfilled). Click here to see the differences between deleting and archiving.
- Once the Study Closeout Form is fully executed, CDS will schedule the study database deletion or archival as of the date indicated in the Study Closeout Form ("Database Change Date").
- Monthly TrialKit invoices will cease once the study is closed by CDS, however:
- If the "Archive" option was selected, an invoice for the annual archival fee will be submitted on the 1st of the following month, payable Net 30. Archival invoices will be sent 1X per year on the effective archival anniversary date.
- When/if archival is no longer desired, proceed back to Step A, initiating the process with a Study Close Out Request and choosing the "Delete" option to request deletion of the study and discontinuation of the archiving (at least 30 days prior to the archival anniversary date).
Close-Out Access Options
In summary, both archived and deleted studies will become inaccessible. Archived studies are retained and backed up indefinitely with supporting archive licensing. Deleted studies will become unrecoverable after 90 days.