{"id":28254,"date":"2021-11-19T11:44:43","date_gmt":"2021-11-19T19:44:43","guid":{"rendered":"https:\/\/www.iths.org\/ctms\/?page_id=28254"},"modified":"2025-08-20T11:17:55","modified_gmt":"2025-08-20T18:17:55","slug":"study-amendments","status":"publish","type":"page","link":"https:\/\/www.iths.org\/ctms\/ctms-submissions\/study-amendments\/","title":{"rendered":"Study Amendments"},"content":{"rendered":"

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Study Amendment Submissions<\/span><\/h2>\n

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Study amendments can occur at any timepoint in a protocol lifecycle, including during study start-up and after open to accrual.<\/p>\n

Study teams will use the REDCap Amendment Submission Survey<\/strong> to determine if protocol changes must be submitted and processed as an amendment. A protocol-specific link to the REDCap Amendment Survey is found in the protocol\u2019s OnCore record, within the PC Console > Documents\/Info > FAQs <\/strong>tab (OnCore login required<\/em>).<\/p>\n

Note<\/strong>: If the correction is a result of a new protocol version or updated budget\/payment terms, this is not a correction. This is a normal amendment submission.<\/p>\n

The table below outlines exclusion criteria that determines when an amendment is not required:<\/span><\/p>\n