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Repeat steps 3-6 for all modules to be modified. Locate the data field to be modified and select Open or Edit for the corresponding module. Select Continue to save the changes and move to next module.

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Once the issue is resolved, it will automatically be removed from the Problems column on your PRS Home page. Note that the record may need to be posted on ClinicalTrials.gov before the problem is removed. Administrators can use the Custom Filter on the Record List to show only records with specific problems. To use this feature, select Custom Filter, then check off appropriate Problem Records filter button. When viewing your Record List on your home page, review the Problems column to identify any Problems on your records. Once you have addressed the problem by editing the study record as directed, the Responsible Party (or an Administrator, Sponsor-Investigator, or Principal Investigator) must release the record for PRS Review again.

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A flag will appear next to each section and module of the study record that has at least one PRS Review Comment to be addressed. To see which of your study records have pending PRS Review Comments, check your Record List for the red flag symbol. Each record that contains PRS Review Comments (Major Comments and/or Advisory Comments) will display the red flag symbol.

Select Open next to the record to be deleted from the Record List on the Home page. Create a new Protocol ID and Brief Title for the copied record. Transfers must be coordinated between the organizations involved. If the receiving organization has Administrators, they are responsible for coordinating the transfer. For organizations without Administrators, the Responsible Party and Record Owners must coordinate the transfer. Update the Record Verification Date data field to the current date. Select Save to save the changes and return to the section page.

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Several kinds of issues can trigger a record being identified as having problems. This section describes possible problems with study records and how to resolve them. Monitor the Problems column of your Record List to identify any records with issues. You may also receive emails from the PRS if problems are not resolved. The Results Section should not be deleted if results are required to be submitted. Select Delete on the Delete Record page or select Cancel to return to the Record Summary page without deleting the record.

Select Quit to save changes and exit the walk-through at any time. Select Open next to the section of the record to be modified on the Record Summary page. In the Record List on your Home page, select Open next to the record you wish to edit. To view all PRS Review Comments ever received on a record, select the Review History link on the Record Summary page. Then, select Review Comments for the version of the record you would like to see. To read PRS Review Comments, find the relevant record from the Record List and open it.