Updating Trials

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.

You can update trial statuses for the trials you own without having to update other trial details.

If you add a status that does not conform to the rules provided in Status Transitions, the system displays errors and/or warnings.
For example, if you add the status Closed to Accrual the system warns you that both the status In Review and Approved are missing. Because Warnings indicate that fixing the record is optional, you do not have to add the indicated statuses. However, Errors indicate that you must record the missing status (in this case, Active) in order to submit the trial for registration

How to Update Trial Status Information

1. Search for the trial whose status information you want to update by following the instructions in Searching for Trials .
   The Search Results table displays the results of your search and actions available (if any) for each record.
   
2. In the Available Actions column, click Select Action > Change Status, or if you want to update other aspects of the trial coincidentally, click Update.
   The Update Trial Status window displays Trial Status fields and lists the previously-recorded trial statuses in the Trial Status History section.
   

3. Edit or add a new status as necessary (see Recording Trial Statuses). If you changed the status to Administratively Complete, Withdrawn, or Temporarily Closed, enter the reason for the status change.

   The system does not change the status of participating sites when you close a trial.

4. To display comments about previous changes to trial status records, hover your cursor over the Comment icon.

   Comments appear in a pop-up message.

   
    

   Errors and Warnings

   The system validates each new status as you add it, as well as when you review the trial information before submitting the trial for registration.

   If you update or add a status that does not conform to the rules provided in Recording Trial Statuses and Dates, the system displays errors and/or warnings. Warnings indicate that fixing the record is optional, you do not have to add/update the indicated statuses. However, Errors indicate that you must record the missing status in order to update the trial.

   If you update a trial registered prior to the CTRP v4.2 release, the Trial Status History records may contain errors and warning as shown below. You must correct each of the errors before you can update the trial.
   
   The system refreshes the Trial Status History records as shown below. After you correct the errors, you can add/update a new status record.

5. Click Review Trial.
   If the system detects errors and/or warnings, it prompts you to correct them. You cannot update the trial until you have corrected all errors.
   

6. Fix any errors as necessary, and then click Review.

7. Click Submit. See Recording Trial Statuses and Dates for detailed instructions.

The trial status dates section captures start, primary completion, and completion dates as they occur according to the rules specified in Updating Trials .

You can update trial start/completion dates for trials you own without having to update other trial details.

How to Update Trial Dates Section

1. Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*) indicates a required field.
2. Indicate whether the dates you entered are Actual or Anticipated.

Valid trial statuses used in CTRP are mapped to ClinicalTrials.gov-defined recruitment values. ClinicalTrials.gov status definitions are provided in Trial Status Values in the CTRP and ClinicalTrials.gov.

Start, Primary Completion, and Completion Date Rules

The Update Participating Sites section captures site statuses and dates. When updating sites, you must follow the the rules specified in Status Transitions below.

For Abbreviated trials, see Updating Participating Site Organization Records .

If you add a status that does not conform to the rules provided in Status Transitions, the system displays errors and/or warnings. Warnings indicate that fixing the record is optional. However, Errors indicate that you must correct the site status and/or status date. 

How to Update Participating Site Status Information

1. Search for the trial whose participating site status information you want to update by following the instructions in Searching for Trials .
   The Search Results table displays the results of your search and actions available (if any) for each record.
   

2. In the Available Actions column, click Select Action > Update. The Update Trial window lists the previously-recorded participating site statuses in the Participating Sites section.

   
   
   

3. Select new statuses and enter dates as necessary.

4. Click Review Trial.
   If you entered invalid values, error messages display instructions for correcting the statuses and/or dates.
   
   
   

5. Fix any errors as necessary, and then click Submit.

   The system does not change the status of participating sites when you close a trial.

Status Transitions

The rules that apply to trial status transitions also apply to participating site status transitions.

After you have completed updating the trial, review the information for errors and edit any details that do not match the changes in your change memo or other source. You can print a copy of the Update Trial pages to facilitate the review and/or keep for your records.

How to Review and Submit Trial Updates

1. Complete all modifications to the most recent trial submission.
2. Scroll to the bottom of the Update Trial page, and click Review Trial.
   The system checks for errors and missing information and displays the results in a message at the top of the Review Trial Details page. Indicators mark specific fields that you must complete or correct in order to submit the trial.

3. Correct any errors if indicated, and repeat the previous step as many times as necessary until the update is error-free.

   The Review Trial Details page is read-only. To edit information that you have reviewed, see Editing Updated Details.

4. Click Submit.

You can edit your updated trial details after you have reviewed them at any time before you submit them to the CTRP.

How to Edit Updated Details

1. Scroll to the bottom of the Review Trial Details page, and click Edit.

   The Update Trial page displays all information you have provided, in editable form.

2. Make changes as necessary and then follow the instructions in Reviewing and Submitting Trial Updates .

You can print a copy of the updated trial to facilitate the review and/or keep for your records. You must review the trial update in order to access the print feature. For instructions on reviewing the trial, see Reviewing and Submitting Trial Updates .

How to Print Updated Trial Information

1. Review the updated trial.

2. Scroll to the bottom of the Review Trial Details page, and click Print.