糖心原创

Continuing review is conducted at the study level only. Information about any institutions relying on the UW for review must be included in the overall study continuing review.

Site and study approvals share the same end date. The approval end date for each site is the same as the approval end date for the study overall.

One report is used for renewal and closure. The continuing review report supports both study renewal and study closure and includes:

• The Continuing Review SmartForm in Zipline
• A Status Report form uploaded to the SmartForm

Closure is triggered by milestones. On the Continuing Review SmartForm, when you indicate that the first four research milestones have been met for the entire study, Zipline prompts you to acknowledge study closure.

For more information:

• Multi-site continuing review process
• Site or study closure process

If the involvement of a relying institution has ended, you may submit a site closure, rather than closing the entire study.

• Site closures are optional. HSD does not require relying sites to be closed in Zipline when site activities stop. You may choose to close a site when the activities of the relying institution鈥檚 employees or agents are no longer considered human subjects research.
• A site closure closes the SITE record in Zipline while keeping the parent STUDY record open.
• Site closure is submitted through a study modification that updates the approved Multi-site or Collaborative Research Supplement to remove the site.
• Once the modification is approved, HSD staff will close the SITE record.
• No site closure letter is issued.

To close the entire study, use the Multi-site Continuing Review or Closure process.

For more information:

• Site or study closure process

• Click Renew or Close in the study workspace
  • The study must be Approved, Lapsed, or Suspended for this action to be available.

• Indicate that the purpose of the submission is continuing review and click Continue

• Your responses should include information for all participating sites.
• In Continuing Review Information #3 (Study wide enrollment totals) on the Continuing Review SmartForm, enter the total number of participants enrolled across all sites.
• You may ignore the system message showing: 鈥�Confirmed sites: X of X. Total enrollment for pSites with completed reports鈥�
• If you select the first four research milestones, Zipline will prompt you to acknowledge that the study will be closed.

The Status Report should describe study progress across all participating institutions, not just the UW site. If your study requires radiation safety approval at UW, attach the radiation safety renewal here as well.

• Click the link to open the Status Report template
• Complete the template and save it to your computer
• Attach the template to the SmartForm, either using drag and drop, or by clicking Add

• Click Save and Exit to leave the SmartForm and return to the submission workspace

• Click Submit and complete required verifications

• In the parent study for the site, locate and download the currently approved SUPPLEMENT Multi-site or Collaborative Research in the Documents tab

• Update the SUPPLEMENT Multi-site or Collaborative Research to remove the information for the site that you wish to close
• Save the revised SUPPLEMENT to your computer

• In the parent study for the site, click Modify Study to initiate a study modification

• Indicate that the purpose of the submission is a modification/update and the modification scope is 鈥淥ther parts of the study鈥� and click Continue

• On the Modification Summary page, indicate that the involvement of a relying institution has ended and the site should be closed, and click Continue

• In the Zipline application, use the left hand navigator to go to the Study Related Documents page and locate the SUPPLEMENT Multi-site and Collaborative Research

• Click UPDATE next to the SUPPLEMENT, select the revised version from your computer, and click OK
• If desired, you can make additional changes to your study application
• Save and exit the SmartForm

• In the modification workspace, click Submit to send the modification requesting site closure to HSD