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).
This section 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
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. 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: Not Started In Process Completed You can use the pie chart in the following ways: The 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 Information for withdrawn trials will not be visible in the Results Reporting Dashboard.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: NCI Trial Identifier Identifier assigned to this trial by the CTRP. Lead Org PO ID Lead Organization 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: You can use search criteria to narrow the list of trials or to search for a specific trial. How to Narrow the List Type or select any of the search criteria listed in the following table as appropriate: Search Criteria You can update trials by entering dates inline. How to Update Trials Type or select any of the dates listed in the following table. If you type the date, use the following format: MM/DD/YYYY PCD Confirmed Results Sent to PIO Results Approved by PIO 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.About the Results Reporting Progress Pie Chart
Status Description Reflects all trials that don’t have dates in the Reporting In Process field. Reflects all trials that have dates in the Reporting In Process field, but not the Trial Results Published Date field. (Includes trials that have XML upload errors.) Reflects all trials that have dates in the Trial Results Published Date field. Issues Reflects all trials that have unresolved XML upload errors and that have no date in the Trial Results Published Date field. (Unresolved XML upload errors are errors that have no date in the Resolution Date field in the Summary of XML Upload Errors & Actions Taken page.) About the Results Reporting List of Trials
Column in Dashboard Description
NCT ID Identifier assigned to this trial by the National Clinical Trial program (ClinicalTrials.gov). CTEP ID Identifier assigned to this trial by the CTEP (Clinical Therapy Evaluation Program). DCP ID Identifier assigned to this trial by the DCP (Division of Cancer Prevention). Identifier assigned to this trial by the lead organization. The name of the principal administrative organization responsible for this trial's research protocol. Results Designee The person designated by CTRO staff to submit results for this trial. PCD The Primary Completion Date (PCD) for this trial. CTRO Trial Comparison Review The date on which the CTRO completed its review of results for this trial. Trial Comparison Approval The date on which the Coordinating Center for Clinical Trials (CCCT) completed its review of results for this trial. CCCT Trial Comparison Review The date on which the system sent a message to the CCCT for its review of results for this trial. Narrowing the List of Trials or Searching for a Trial
Instructions Trial Identifier To search for a particular trial, type all or part of the NCI trial ID. Section 801 Indicator Primary Completion Date Type Updating Trials
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. 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. Type or select the date on which the CTA sent results for this trial to the PIO. The CTA sends this information by email. 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
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 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. Click Search, and follow the instructions in Searching for Persons in PA. Type any CTRP-specific comments about this contact. This field is not included in the nightly feed to ClinicalTrials.gov. If you want to add another Results Designee contact, provide the new contact information and click Add/Update Designee. Repeat as needed. How to Remove a Contact
Field Instructions Organization* Click Search, and follow the instructions in Searching for Organizations in PA. Name* 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 Ext If the contact's phone number has an extension, type it in this field. You can enter up to 200 characters.
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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 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. Click Search, and follow the instructions in Searching for Persons in PA. If you want to add another PIO contact, provide the new contact information and click Add/Update PIO. Repeat as needed. 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
Field Instructions Name* 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.
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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 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
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 Enter the appropriate information in each field. The following table describes the fields. All fields are required. Change Type* 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 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
Field Instructions 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.
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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 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. Select Yes in this field after you have provided the following answers in PRS: 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. 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. 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: 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: 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: How to Send the Trial Cover Sheet
Field Instructions Certain Agreements Use Standard Language?* 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 – Confirm “Send trial information to ClinicalTrials.gov?” is set to “No” Results Designee Access Revoked?
MM/DD/YYYYAll Changes Made in CTRP and ClinicalTrials.gov?
MM/DD/YYYY
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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 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: 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
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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.
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
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