Decommission a Production study

Review the details below to familiarize yourself with some reasons for decommissioning a study and the necessary steps.

When should a study be decommissioned?

• During the renewal process, you determined that a study is no longer needed.
• The study conduct period ended as planned, and you no longer require access to the study or its data through the Oracle Clinical One Platform user interface.
• The study conduct period ended sooner than expected, and you no longer require access to the study or its data through the Oracle Clinical One Platform user interface.

There are three steps in the process of decommissioning a study. First, confirm you have access to generate reports and archives, generate and download them, and finally initiate the decommissioning process.

1. Confirm you have access to generate and download reports and archives.
   1. Log in to Oracle Clinical One Platform.
   2. Locate the study that is to be decommissioned and open the Study Settings.
   3. Click the Users tab, select your user, click Manage Users, then click Edit.
   4. On the Details & Roles page, confirm that you are assigned the View Only for Unblinded Support Users study role in Production Mode. Then, on the Sites & Depots page, confirm that all sites and depots are assigned.

      Note:

      If you need your assignments updated, contact your delegated administrator.
   5. Repeat this process for each study if you need to decommission multiple studies.
2. Generate and download the final reports and archives.

   It is the customer's obligation to retrieve all necessary study data before the end of the Services Period.

   Generate the necessary reports and archives before contacting Oracle to start the decommissioning process. For more information about reports and archives, see the Reporting Guide.

   WARNING:

   You cannot generate reports and archives in the Oracle Clinical One Platform user interface approximately seven to ten (7 to 10) days after Oracle initiates the decommissioning process.
   1. From the home page, open the study, then click Reports & Archives to access the Reports and Archives tabs.
   2. Select and generate each end-of-study report and archive you require for decommissioning a study.
      For more information, see Descriptions for Standard Reports and Available Archives and Reports.
   3. To include all required information in the output, select a date range comprising the studies' beginning and ending dates.
   4. Generate the output for each report and archive, then save the output (CSV and PDF) to a secure location.
3. Request to have a study decommissioned.
   • Decommission a single study that is part of a single study order:
     1. The customer initiates the process by informing their sales contact that they are not renewing the contract or are requesting early study termination.

        Note:

        Oracle requires advanced notice for studies terminated earlier than expected. Your contract includes the notification period required. The decommissioning process starts once the notification period ends.
     2. After being contacted, sales initiates the decommissioning process.
     3. Oracle places a copy of the study data in a pluggable database (PDB) package, consisting of one .dmp file, on the Oracle sFTP server and notifies the customer's primary study contact that the PDB package is ready for retrieval. The primary study contact must retrieve the package within 60 days of Oracle's initial notification. Oracle automatically deletes the package after 60 days.

        Note:

        Reach out to your Oracle point of contact if you do not know the primary contact, want to change it, or need other assistance.
     4. After 60 days, Oracle deletes the study data and its components from the Oracle server. This final step completes the decommissioning process.

        Note:

        The primary contact receives reminders seven (7) days and twenty-four (24) hours before deleting the study.
   • Decommission a single study that is part of a multi-study capacity order:

     Table 6-1 Study decommission - multi-study capacity order

     Study type	Owner & Responsibilities
     Oracle built studies	The customer initiates the process by informing their sales contact that they are not renewing the contract or are requesting early study termination. Note: Oracle requires advanced notice for studies terminated earlier than expected. Your contract includes the notification period required. The decommissioning process starts once the notification period ends. After being contacted, sales initiates the decommissioning process. For details about what happens after sales initiates the process, refer to steps c. and d. above in section 3. Request to have a study decommissioned.
     Customer built studies	The customer creates the Change Request (CR) to initiate the decommissioning process. Note: For information about creating a CR, see LSGBU Support Cloud Guide for Change Requests. If you encounter issues with the link above, log into Oracle Life Sciences Support Cloud, click the menu icon in the upper-left corner, and then select Documents & Request Forms. For details about what happens after creating the CR, refer to steps c. and d. above in section 3. Request to have a study decommissioned.