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As trial owner, you can update a subset of the information included with the original trial submission, including the following:
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 UpdatesThe Update Trial feature accommodates the following type of protocol document changes.
How to Update Trials
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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. How to Update Trial Status Information
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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
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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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
Status TransitionsThe 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
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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
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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
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