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For each registered and completed trial, the Study Sponsor or Principal Investigator submits results information to the Protocol Registration and Results System (PRS) of ClinicalTrials.gov. A department of the National Library of Medicine manages the ClinicalTrials.gov website, specifically the PRS Team. While the PRS Team reviews these results in PRS, the NCI Clinical Trials Reporting Office (CTRO) reviews these results in the CTRP Protocol Abstraction application (PA).
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page tree provides instructions for CTRO staff to track and manage trial results. The system associates your CTRP account with your role when you log in to PA. If you have the Results Abstractor role, the system automatically displays the Results Reporting Dashboard.
Using the Results Reporting Dashboard
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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 ChartThe 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:
About the Results Reporting List of TrialsThe Results Reporting Dashboard lists trials that meet all of the following criteria:
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 Information for withdrawn trials will not be visible in the Results Reporting Dashboard.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:
To export the list of trials to a file, scroll down to the end of the list and click one of the following:
Narrowing the List of Trials or Searching for a TrialYou can use search criteria to narrow the list of trials or to search for a specific trial. How to Narrow the List
Updating TrialsYou can update trials by entering dates inline. How to Update Trials
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Managing Results Designee Contact Information
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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
How to Remove a Contact
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Managing PIO Contact Information
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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
How to Remove a Contact
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Managing Trial Comparison Documents
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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
To view a document, click its file name link. How to Remove Documents
How to Replace Documents
How to Indicate Review Progress
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Managing Record Changes
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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
How to Delete a Record Changes Entry
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Managing Final Record Clean-up and Release
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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
How to Send the Trial Cover Sheet
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Managing XML Upload Errors
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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
- In the list of trials, click the NCI trial identifier link for the trial you want to edit. A page appears with several sections.
- 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.
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 |
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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. |
Enter the appropriate information in each field. The following table describes the fields. All fields are optional.
Type or select the date on which this error was resolved. If you type the date, use the following format:
MM/DD/YYYY