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The CTRP processes submissions in much the same way as it processes original trial data. (For information, refer to Typical Life Cycle of a Trial.) You may need to submit an amendment more than once during the course of your study, and the process is repeated each time you submit an amendment. The progression of your trial throughout the phases of the life cycle relies on a series of communications. These communications take the form of email messages between you and the system at certain milestone events, as follows:
The amended trial appears in your Search My Trials results list upon acceptance.
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In your role as trial owner (original submitter or current owner), you can amend only Complete trials. The trials you own are listed when you use the Search My Trials feature. Refer to Searching for Trials. In addition to rules provided in Registering New Trials, the following rules apply to amendments:
When you are submitting an amendment, we recommended that you provide any additional documents that you think will be useful to the CTRO for reviewing and processing the amendment document.
Examples of AmendmentsThe following are examples of amendments that the Amend Trial feature accommodates.
How to Amend Trials
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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 Amend Trial pages to facilitate the review and/or keep for your records. How to Review and Submit Trial Amendments
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You can edit your amended trial details after you have reviewed them at any time before you submit them to the CTRP. How to Edit Amended Details
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You can print a copy of the amended trial to facilitate the review and/or keep for your records. You must review the amendment in order to access the print feature. For instructions on reviewing the trial, see Reviewing and Submitting Trial Amendments. How to Print Amended Trial Information
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