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 a study's settings. See Open the study settings.
   3. Select the Users tab.
   4. On the Users tab, select your user. Select Manage Users, then select Edit.
   5. On the Edit User dialog, the Details & Roles section, confirm that you are assigned the View Only for Unblinded Support Users study role in Production Mode.
   6. Select Next and, on the Sites & Depots section, confirm that all sites and depots are assigned to you.

      Note:

      If you need your assignments updated, contact your delegated administrator.
   7. If you need to decommission multiple studies, repeat this process for each study.
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 and download the necessary reports and archives before contacting Oracle to initiate decommissioning. 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 select the Reports & Archives page.
   2. Select and generate each end-of-study report and archive you require for decommissioning a study.
      For more information, see Standard reports and Available archive types and reports in the Reporting Guide.
   3. To include all required information in the output, select a date range comprising the study's beginning and ending dates.
   4. Generate the output for each report and archive, then save the output (in a CSV and PDF format) to a secure location.
3. Request to have a study decommissioned. You can do either one of the following:
   • 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.

        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, the sales team initiates the decommissioning process.
        When decommissioning a study, the first step is to delete all previously generated study-level standard reports from all modes. Removing this large volume of historical reporting data minimizes the possibility of issues when exporting the study.

        Note:

        This step includes the Drug Order and Drug Reconciliation forms, which are considered reports in Oracle Clinical One Platform studies.

        This process does not include the following global-level reports: the Global Study Roles report, the Life Sciences Learn Training Report, the Study Roles Report by Study, and the User Assignment Across Studies report.

     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. The primary contact receives reminders seven (7) days and twenty-four (24) hours before deleting the study.

        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.
   • 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 study	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. For information about creating a CR, see LSGBU Support Cloud Guide for Change Requests. Note: If you encounter issues with the link above, log into Oracle Life Sciences Support Cloud. Then, in the upper-left corner, select the Menu , 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.