Tracking and Managing Trial Results v4.4

Using the Results Reporting Dashboard

To access the Results Reporting Dashboard, in the main menu, under Dashboards, click Results Reporting. This link is visible only to users with the Results Abstractor role. The Results Reporting Dashboard displays a pie chart and a list of trials.

About the Results Reporting Progress Pie Chart

The Results Reporting Dashboard also provides a Results Reporting Progress pie chart. This chart reflects the data from the list of trials.

This pie chart provides the following information:

You can use the pie chart in the following ways:

• If you use the search fields at the top of the Results Reporting Dashboard to narrow the list of trials, the pie chart reflects the data from the list of results.
• If you add a date to the Reporting In Process field or the Trial Results Published Date field for a trial in the list and refresh your browser, the pie chart reflects that change.
• If you add a date to the Resolution Date field for a trial listed in the Summary of XML Upload Errors & Actions Taken page and return to the Results Reporting Dashboard, the pie chart reflects that change.

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About the Results Reporting List of Trials

The Results Reporting Dashboard lists trials that meet all of the following criteria:

• Criteria for original submissions:
  
  • NCI Sponsored trials.
  • Interventional trials.
  • Trials with lead organizations other than the NCI - Center for Cancer Research. 
  • Trials with a Processing Status of Abstraction Verified Response, Abstraction Verified No Response, or Verification Pending.
• Criteria for amended or updated trials:
  
  • NCI Sponsored trials.
  • Interventional trials.
  • Trials with lead organizations other than the NCI - Center for Cancer Research. 

Results reporting and tracking information is available in the Results Reporting Dashboard for the active version of a trial regardless of amendments/amendment-rejections. When users submit (or reject) amendments for a trial, the results reporting information for that trial remains unchanged. Information for withdrawn trials will not be visible in the Results Reporting Dashboard. 

The Results Reporting Dashboard provides up-to-the-minute details of each trial, including the following:

By default, the system sorts the trials by NCI Trial Identifier. To sort the list by any other column, click any column header. To reverse the order, click the column header again. An arrow indicates the sort order:

• Ascending: Down arrow indicates that you can click to sort in descending order.
• Descending: Up arrow indicates that you can click to sort in ascending order.

To export the list of trials to a file, scroll down to the end of the list and click one of the following:

• Click CSV to create a generic comma-separated value file.
• Click Excel to create a Microsoft Excel spreadsheet.

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Narrowing the List of Trials or Searching for a Trial

You can use search criteria to narrow the list of trials or to search for a specific trial.

How to Narrow the List

1. Type or select any of the search criteria listed in the following table as appropriate:

   Search Criteria	Instructions
   Trial Identifier	To search for a particular trial, type all or part of the NCI trial ID.
   Section 801 Indicator	To limit the search results to trials with the Section 801 Indicator set to Yes, select Yes. To limit the search results to trials with the Section 801 Indicator set to No, select No.
   Primary Completion Date	To limit the search results to trials with a Primary Completion Date within a range of dates, specify those dates in the To and From fields.  To limit the search results to trials with a Primary Completion Date after a specific date, specify that date in the From field and leave the To field blank. To limit the search results to trials with a Primary Completion Date before a specific date, specify that date in the To field and leave the From field blank.
   Type	To limit the search results to trials with an actual Primary Completion Date, select Actual. To limit the search results to trials with an anticipated Primary Completion Date, select Anticipated. To expand the search results to trials with any type of Primary Completion Date, select Any.

2. Click Search. The search results appear in the dashboard.

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Updating Trials

You can update trials by entering dates inline.

How to Update Trials

1. Type or select any of the dates listed in the following table. If you type the date, use the following format:

   MM/DD/YYYY

   Column in Dashboard	Instructions
   PCD Sent to PIO	Type or select the date on which the Clinical Trials Administrator (CTA) sent the PCD for this trial to the Protocol and Information Office (PIO), which is DCP's administrative arm. The CTA sends this information as a Microsoft Excel spreadsheet by email.
   PCD Confirmed	Type or select the date on which CTEP or DCP PIO confirmed the PCD for this trial. The CTEP or DCP PIO confirms the PCD by email.
   Designee Notified	Type or select the date on which the CTA notified the Results Designee to begin reporting results for this trial in PRS.
   Reporting in Process	Type or select the date on which the CTA granted the Results Designee access to the trial in PRS, for the purpose of reporting results.
   3 Month Reminder	Type or select the date on which the CTA sent a reminder to the Results Designee, typically three months after the Reporting in Process date. The reminder message reminds the designee to finish reporting results for this trial by seven months after the Reporting in Process date.
   5 Month Reminder	Type or select the date on which the CTA sent another reminder to the Results Designee, typically five months after the Reporting in Process date.
   7 Month Escalation	Type or select the date on which the CTA sent an escalation to the PIO for this trial. The CTA sends this information by email.
   Results Sent to PIO	Type or select the date on which the CTA sent results for this trial to the PIO. The CTA sends this information by email.
   Results Approved by PIO	Type or select the date on which the PIO approved the results for this trial. The PIO sends this approval by email.
   PRS Release Date	Type or select the date on which PRS released this trial to the PRS Team for review.
   QA Comments Returned Date	Type or select the date on which the PRS Team returned QA comments on this trial.
   Trial Results Published Date	Type or select the date on which ClinicalTrials.gov published this trial's results, making them available to the public. In addition, the system automatically updates this field when the trial has results published in ClinicalTrials.gov.

2. To commit each change, click elsewhere on the screen. A brief message appears under the field you have changed, indicating that the change has been saved. 

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Managing Results Designee Contact Information

For efficient management of trial results, the CTRO needs to maintain contact with the Results Designee for each trial. In the PA application, you can track one or more Results Designee contacts.

How to Add or Edit the Results Designee Contact

1. In the main menu, under Dashboards, click Results Reporting. This link is visible only to users with the Results Abstractor role. The Results Reporting Dashboard displays a list of trials.
2. Navigate using one of the following ways:
   
   1. In the list of trials, click the NCI trial identifier link for the trial you want to edit. A page appears with several sections, including the Results Designee Contact section. 
   2. In the panel next to the pie chart, under Add/Update Designee or PIO Contact, type the trial ID and click Search. The Add/Update Contact Information page appears with multiple sections, including the Results Designee Contact section.
      

3. In the Results Designee Contact section, provide the contact information. Enter the appropriate information in the fields. The following table describes the fields. An asterisk (*) indicates a required field.

   Field	Instructions
   Organization*	Click Search, and follow the instructions in Searching for Organizations in PA.
   Name*	Click Search, and follow the instructions in Searching for Persons in PA.
   PRS User Name	Type the contact's user name as it appears in PRS. You can enter up to 200 characters.
   Email*	Type the email address of the contact. You can enter up to 200 characters.
   Phone	Type the phone number of the contact. You can enter up to 200 characters.
   Comments	Type any CTRP-specific comments about this contact. This field is not included in the nightly feed to ClinicalTrials.gov.
   Ext	If the contact's phone number has an extension, type it in this field. You can enter up to 200 characters.

4. Click Add/Update Designee. The system saves the information that you have entered and displays it as a new row. The system also resets the form.
   

5. If you want to add another Results Designee contact, provide the new contact information and click Add/Update Designee. Repeat as needed.

6. To edit a contact, click the edit icon () in the row of the contact you want to edit. The system populates the fields of the Results Designee Contact section with the contact you have selected. Edit those fields and click Add/Update Designee.

How to Remove a Contact

1. Click the trash can icon () in the row of the contact you want to remove. The system asks you to confirm the removal.
2. Click OK.

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Managing PIO Contact Information

For efficient management of trial results, the CTA needs to maintain contact with the PIO contact for each trial. In the PA application, you can track one or more PIO contacts.

How to Add or Edit the PIO Contact

1. In the main menu, under Dashboards, click Results Reporting. This link is visible only to users with the Results Abstractor role. The Results Reporting Dashboard displays a list of trials.
2. Navigate using one of the following ways:
   1. In the list of trials, click the NCI trial identifier link for the trial you want to edit. A page appears with several sections, including the Assigned PIO section.
   2. In the panel next to the pie chart, under Add/Update Designee or PIO Contact, type the trial ID and click Search. The Add/Update Contact Information page appears with multiple sections, including the Assigned PIO section.
      

3. In the Assigned PIO section, provide the contact information. Enter the appropriate information in the fields. The following table describes the fields. An asterisk (*) indicates a required field.

   Field	Instructions
   Name*	Click Search, and follow the instructions in Searching for Persons in PA.
   Email*	Type the email address of the contact. You can enter up to 200 characters.
   Phone	Type the phone number of the contact. You can enter up to 200 characters.
   Ext	If the contact's phone number has an extension, type it in this field. You can enter up to 200 characters.

4. Click Add/Update PIO. The system saves the information that you have entered and displays it as a new row. The system also resets the form.
   

5. If you want to add another PIO contact, provide the new contact information and click Add/Update PIO. Repeat as needed.

6. To edit a contact, click the edit icon () in the row of the contact you want to edit. The system populates the fields of the Assigned PIO section with the contact you have selected. Edit those fields and click Add/Update PIO.

How to Remove a Contact

1. Click the trash can icon () in the row of the contact you want to remove. The system asks you to confirm the removal.
2. Click OK.

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Managing Trial Comparison Documents

The CTRO and CCCT review the registration information and results for a trial by comparing Microsoft Word protocol documents.

How to Add Microsoft Word Documents

1. In the main menu, under Dashboards, click Results Reporting. This link is visible only to users with the Results Abstractor role. The Results Reporting Dashboard displays a list of trials.
2. Navigate using one of the following ways:
   
   1. In the list of trials, click the NCI trial identifier link for the trial you want to edit. A page appears with several sections, including the Trial Comparison Documents section. 
   2. In the panel next to the pie chart, under View/Upload Trial Comparison Documents, type the trial ID and click Search. The View/Upload Trial Comparison Documents page appears, including the Trial Comparison Documents section.
      
3. In the Trial Comparison Documents section, click Add. The Add/Edit Document section appears.
   
4. From the Document Type list, select the document type: Before results, After results, or Comparison.  
5. In the File Name field, click Browse. Navigate to and select your Microsoft Word protocol document.
6. Click Save. The document appears in the list with a date stamp reflecting the current date. When the comparison document upload completes, the system sends a copy of it by email to ncictro@mail.nih.gov.

To view a document, click its file name link.

How to Remove Documents

1. To remove a document, click the trash can icon () in the row of the document you want to remove . The system asks you to confirm the removal.
2. Click OK. The system keeps all documents and associated data, but removes the document and timestamps from the Trial Comparison Documents section. Depending on which document you removed, the system performs some cleanup:
   • If you remove a Before Results document or an After Results document, the system automatically removes the Comparison document.
   • If you remove an Comparison document, the system automatically removes any review timestamps associated with that document. The system prompts you to upload an updated Comparison document.

How to Replace Documents

1. Click the edit icon () in the row of the document you want to replace. The Add/Edit Document section appears. The Document Type field is read-only.
2. In the File Name field, click Browse. Navigate to and select your Microsoft Word protocol document.
3. Click Save. The system performs cleanup, as described above.

How to Indicate Review Progress

1. In the Trial Comparison Documents section, in the comparison document row, click the Yes that corresponds to your role:
   • If you represent CTRO, click the Yes in the CTRO Review Complete? column. The CTRO Review Complete dialog box appears, listing all users with the Administrative Abstractor, Scientific Abstractor, Super Abstractor, or Results Abstractor role. Select the appropriate CTRO user name.
     
   • If you represent CCCT, click the Yes in the CCCT Review Complete? column. The CCCT Review Complete dialog box appears. Type the appropriate CCCT user name. You can enter up to 2000 characters.
     
2. Click Save. The specified user name and a date-stamp appears in place of the Yes button.
   
   • After the CTRO review has been completed, the system sends a copy of the Comparison document by email to CCCT.
   • After both reviews have been completed, the system sends a copy of the Comparison document by email to specific members of the CTRO and CCCT, with an extract from the Cover Sheet page.

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Managing Record Changes

While reviewing the results of a trial, you might need to make some record changes. The PA application allows you to track and manage these record changes.

How to Add or Edit Record Changes

1. In the main menu, under Dashboards, click Results Reporting. This link is visible only to users with the Results Abstractor role. The Results Reporting Dashboard displays a list of trials.
2. Navigate using one of the following ways:
   1. In the list of trials, click the NCI trial identifier link for the trial you want to edit. A page appears with several sections, including the Record Changes section.
   2. In the panel next to the pie chart, under Results Cover Sheet, type the trial ID and click Search. The Cover Sheet page appears with multiple sections, including the Record Changes section.
      
3. To add an entry, in the Record Changes section, click Add. The Add/Edit Study Record Change dialog box appears.
   

4. Enter the appropriate information in each field. The following table describes the fields. All fields are required.

   Field	Instructions
   Change Type*	Type a description of the change. Examples include Eligibility Criteria and Addition of Arms. Also consider discrepancies in Status, Status Dates, or Accrual. You can enter up to 2000 characters.
   Action Taken*	Type a description of the action taken to address the change. You can enter up to 2000 characters.
   Action Completion Date*	Type or select the date on which the action was taken. If you type the date, use the following format: MM/DD/YYYY

5. In the Add/Edit Study Record Change dialog box, click Save.
   

6. To edit a record change, click the edit icon () in the row of the record change you want to edit. The Add/Edit Study Record Change dialog box appears. Edit the values and click Save.

How to Delete a Record Changes Entry

1. Click the trash can icon () in the row of the entry you want to delete. The system asks you to confirm the deletion.
2. Click OK.

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Managing Final Record Clean-up and Release

After reviewing the results of a trial, some final clean-up is necessary. The questions in this section serve as a confirmation that certain sections of the trial have been examined. However, it is not necessary for a trial to have a Yes in every field before the CTA releases it to the PRS Team.

How to Perform the Final Clean-up

1. In the main menu, under Dashboards, click Results Reporting. This link is visible only to users with the Results Abstractor role. The Results Reporting Dashboard displays a list of trials.
2. Navigate using one of the following ways:
   1. In the list of trials, click the NCI trial identifier link for the trial you want to edit. A page appears with several sections, including the Final Record Clean-up & Release section.
   2. In the panel next to the pie chart, under Results Cover Sheet, type the trial ID and click Search. The Cover Sheet page appears with multiple sections, including the Final Record Clean-up & Release section.
      

3. In the Final Record Clean-up & Release section, enter the appropriate information in the fields. The following table describes the fields. An asterisk (*) indicates a required field.

   Field	Instructions
   Certain Agreements Use Standard Language?*	Select Yes in this field after you have provided the following answers in PRS: PRS Question CTRO Standard Answer Are all PIs Employees of the Sponsor? No Results Disclosure Restriction on PI(s)? Yes PI Disclosure Restriction Type The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
   If Completed, Terminated, Withdrawn – Completion Date Entered in PRS?	This field becomes relevant when the trial has a Current Trial Status of Complete, Administratively Complete, or Withdrawn in the PA application. In that case, select Yes in this field if the following is true: In the PA application, under Trial Status, the Completion Date for the trial has a date, and PRS has the same date.
   If Completed, Terminated, Withdrawn – Confirm “Send trial information to ClinicalTrials.gov?” is set to “No”	This field becomes relevant when the trial has a Current Trial Status of Complete, Administratively Complete, or Withdrawn in the PA application. In that case, select Yes in this field if the following is true: In the PA application, in the NCI Specific Information section, the trial has No in the Send trial information to ClinicalTrials.gov? field.
   Results Designee Access Revoked?	This field becomes relevant when the PRS Team publishes the trial with results in ClinicalTrials.gov. In that case, select Yes in this field if the CTA removed the Results Designee user account from the trial record access list in PRS. If you select Yes, type or select the date on which the CTA revoked the Results Designee's access. If you type the date, use the following format: MM/DD/YYYY
   All Changes Made in CTRP and ClinicalTrials.gov?	This field becomes relevant when the CTRO makes changes to the trial since the Reporting in Process date, in any system (CTRP or PRS).  In that case, select Yes in this field if both of the following conditions are true: In the PA Results Reporting Dashboard, in the Record Changes section, the CTRO has completed all action items for the trial.  The CTA has uploaded those changes to ClinicalTrials.gov. If you select Yes, type or select the date on which the CTA uploaded the changes. If you type the date, use the following format: MM/DD/YYYY

How to Send the Trial Cover Sheet

1. Make sure that the trial has a trial comparison document. The system does not send a cover sheet without it.
2. Consider also including a Results Designee contact for the trial.
3. When you are ready for the system to send an email message with an extract from the Cover Sheet page to specific members of the CTRO and CCCT, click Email Trial Cover Sheet.

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Managing XML Upload Errors

During upload of trials to ClinicalTrials.gov, some errors may occur. The PA application allows you to track and manage these errors.

How to Edit Records of Upload Errors

1. In the main menu, under Dashboards, click Results Reporting. This link is visible only to users with the Results Abstractor role. The Results Reporting Dashboard displays a list of trials.
2. Navigate using one of the following ways:
   1. In the list of trials, click the NCI trial identifier link for the trial you want to edit. A page appears with several sections.
   2. In the panel next to the pie chart, under XML Upload Errors & Actions Taken, type the trial ID and click Search. (To manage the errors for all trials, omit the trial ID and just click Search.) The Summary of XML Upload Errors & Actions Taken page appears.
      

3. Examine the available information. The Summary of XML Upload Errors & Actions Taken section lists errors from the previous night's upload or the most recent upload to ClinicalTrials.gov. The system provides information from that email message. The following table describes the columns:

   Field	Description
   Error Date	The date of the message in which the system found the error.
   NCI Trial ID	Identifier assigned to this trial by the CTRP.
   NCT Trial ID	Identifier assigned to this trial by the National Clinical Trial program (ClinicalTrials.gov).
   Error Message	The error as written in the previous night's status email message from ClinicalTrials.gov.
   Recurring Error?	An indication of whether the same error has occurred for this trial on another day in the past 30 days.

4. To add or change information for an error, click the edit icon () in the row for that error. The Add/Edit Actions Taken Record dialog box appears. 
   
   

   Enter the appropriate information in each field. The following table describes the fields. All fields are optional.

   Field	Instructions
   Comments	Type a comment that you think might be helpful to other people who need to work on this error, or as a reminder for yourself. You can enter up to 5000 characters.
   Error Type	Type the name of an error type. You can enter up to 50 characters.
   CMS Ticket ID	Type the CMS Ticket ID, from Enterprise Wizard, the CTRO ticketing system. You can enter up to 50 characters.
   Actions Taken	Type a description of the actions taken to address this error. You can enter up to 5000 characters.
   Resolution Date	Type or select the date on which this error was resolved. If you type the date, use the following format: MM/DD/YYYY

5. Click Save. In each row, the system displays the user name and date for the most recent update.

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