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Page History
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Updating Trial Information
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| MultiExcerptName | updatetrial |
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NIH grant information (for NIH-funded trials).
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You can add grants but you can not update existing grant information. |
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- Site recruitment status and associated date for abstracted trial sites. See Recording Trial Statuses and Dates .
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Status dates
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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. |
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Trial documents
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Documents you upload when using the Update Trial feature do not overwrite existing documents. |
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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
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An asterisk ( * ) at the end of a trial title indicates that the trial has alternate titles. |
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If applicable, enter an ClinicalTrials.gov Identifier, and then click Add ClinicalTrials.gov Identifier.
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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. |
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Make changes to the fields as necessary. Instructions for recording each of the fields are provided in Registering New Trials .
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| MultiExcerptName | updatestatus |
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You can update trial statuses for the trials you own without having to update other trial details.
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After your trial has been accepted, you can change the trial status information directly from the Search Results table without having to open the trial record. To use this method, search for the trial, and then, in the Search Results table's Action column, select Change Status. |
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| title | Errors and Warnings |
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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
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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.
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To display comments about previous changes to trial status records, hover your cursor over the Comment icon.
Comments appear in a pop-up message.
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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.
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Click Submit. See Recording Trial Statuses and Dates for detailed instructions.
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| MultiExcerptName | submittrialstatus |
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You can update trial start/completion dates for trials you own without having to update other trial details.
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After your trial has been accepted, you can change the trial status information directly from the Search Results table without having to open the trial record. To use this method, search for the trial, and then, in the Search Results table's Action column, select Change Status. |
How to Update Trial Dates Section
- 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.
- Indicate whether the dates you entered are Actual or Anticipated.
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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
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Updating Participating Site Statuses in Complete Trials
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| MultiExcerptName | updatesitestatus |
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For Abbreviated trials, see Updating Participating Site Organization Records .
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The system validates the trial and site status transition(s) you make to each participating site when you review the trial information. |
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
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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.
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Select new statuses and enter dates as necessary.
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Fix any errors as necessary, and then click Submit.
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Status Transitions
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The rules that apply to trial status transitions also apply to participating site status transitions.
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Reviewing and Submitting Trial Updates
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| MultiExcerptName | updatetrialreview |
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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
- Complete all modifications to the most recent trial submission.
- 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. Correct any errors if indicated, and repeat the previous step as many times as necessary until the update is error-free.
Info The Review Trial Details page is read-only. To edit information that you have reviewed, see Editing Updated Details.
- Click Submit.
Editing Updated Details
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| MultiExcerptName | updatetrialedit |
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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
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.
Make changes as necessary and then follow the instructions in Reviewing and Submitting Trial Updates .
Printing Updated Trial Information
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| MultiExcerptName | updatetrialreviewprint |
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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
Review the updated trial.
Scroll to the bottom of the Review Trial Details page, and click Print.
