Updating Trial Information - Include v4.4

As trial owner, you can update a subset of the information included with the original trial submission, including the following:

• ClinicalTrials.gov Identifier (other than Industrial/Other trials)
• Other Identifier
• Local Trial Identifier (Industrial/Other trials)
• Title (other than Industrial/Other trials)
• Accrual Disease Terminology (other than Industrial/Other trials)

• NIH grant information (for NIH-funded trials).

  You can add grants but you can not update existing grant information.

• Participating site
  
  • Site recruitment status and associated date for abstracted trial sites. See Recording Trial Statuses and Dates .

• Status dates

  Changing the overall trial status must reflect changes to the trial status at the site. For example, if you change the overall status from Approved to Active, you must change the recruitment status from Not Yet Recruiting to Recruiting.

• Trial documents

  Documents you upload when using the Update Trial feature do not overwrite existing documents.

You can change the trial status information directly from the Search Results table without having to open the trial record. To use this method, in the Search Results table's Action column, select Change Status and make your changes as per the instructions in Recording Trial Statuses and Dates .

Protocol Document Updates

The Update Trial feature accommodates the following type of protocol document changes.

• Editorial, Administrative Changes (correction of minor typographical errors; clarifications made to previously approved descriptions of research)
• Data, Data Collection, and Data Collection Materials (revised study diaries; revised questionnaires or QOL surveys given to participants)
• Recruitment of Subjects (changes in the way subjects are recruited; a new or revised advertisement)
• Principal Investigator Contact Information

 

How to Update Trials

1. Click Search > Clinical Trials.
   The Search Trials page appears.
2. Click Search > My Trials.
   The Search Results table displays the results of your search and actions available (if any) for each record. For information about navigating the search results list, see Viewing Trial Details .
   
   
   "Available Actions" Columns for Complete trials - Select Action List
   
   
   "Available Actions" Columns for Industrial trials - Select Action List
   

3. In the Available Actions column, click Select Action > Update.
   The Update Trial page displays the data currently registered with CTRP.
   
   Update Trial page for Complete trials
   

   
   Update Trial page for Industrial trials
   
   

   An asterisk ( * ) at the end of a trial title indicates that the trial has alternate titles.

   

4. To view the alternate titles, click the asterisk ( * )
   
   

5. If applicable, enter an ClinicalTrials.gov Identifier, and then click Add ClinicalTrials.gov Identifier. 

   You cannot change the ClinicalTrials.gov Identifier once you have added it. If you need to make changes thereafter, contact the CTRO at NCICTRO@mail.nih.gov.

   When you submit the trial, the system checks the NCT number you entered to ensure that no other registered trial has the same one. The system displays an error message if it finds another trial with the same NCT number. If this occurs, check the number you entered and try again. If you are certain that the number you entered is correct, contact the CTRO at NCICTRO@mail.nih.gov.

    

6. Make changes to the fields as necessary. Instructions for recording each of the fields are provided in Registering New Trials .

7. If appropriate, upload any new or updated documents. See Recording Trial-Related Documents .
   If you upload an IRB document, the CTRO reviews the updated record you submit and makes changes to the record as necessary. For example, if you upload an IRB document for a trial currently in the In Review state, the CTRO updates the IRB information section of the trial record (e.g., IRB status and approval number).
8. To review the information you provided, click Review Trial.
   The system checks the updated information for errors, and displays the results at the top of the Update Trial page.
9. If necessary, correct any errors, and click Review Trial. Repeat this cycle until your update is error-free.
10. Submit the trial update.
    The system sends you an update notification—with the details of what has changed—whenever you update accepted trials.