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
- Click Search > Clinical Trials.
The Search Trials page appears. - 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, refer to Viewing Trial Details.
"Available Actions" Columns for Complete trials - Select Action List
"Available Actions" Columns for Industrial trials - Select Action List 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.
- To view the alternate titles, click the asterisk ( * )
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.
Make changes to the fields as necessary. The instructions are the same for trial registration and trial update, with some exceptions:
A trial can accumulate program codes from different organization families. For example, a participating site might belong to a different organization family than the lead organization. When you update a trial, the Program Code field displays all codes from the master list for the organization family of the lead organization.
- If appropriate, upload any new or updated documents. For instructions, refer to Uploading 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).
For instructions on recording each field otherwise, refer to Registering New Trials.
- 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. - If necessary, correct any errors, and click Review Trial. Repeat this cycle until your update is error-free.
- Submit the trial update.
The system sends you an update notification—with the details of what has changed—whenever you update accepted trials.