Managing Trial Comparison Documents - Include v4.4

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.