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Updating a study version

Changes in a trial protocol typically require IRB approval, and their implementation needs to be carefully timed. When a protocol change is approved, the trial can begin to use the new forms, if any, associated with the change when you:

  1. Create a new STUDYVERSION, including the new or changed forms, by copying or revising the definition of the old STUDYVERSION, changing the VERSIONDESCRIPTION attribute, and updating the STUDYVERSIONDOC description in the same way.
  2. Deploy the new STUDYVERSION definition at the sites by updating the VERSIONDESCRIPTION attribute of each STUDYVERSIONSITE element where the change applies. For a form change that does not involve a protocol amendment, update the STUDYVERSIONSITE element for each site. For a change that does involve a protocol amendment, update the STUDYVERSIONSITE element for a site only as it receives IRB approval or other authorization (for example, communication from the sponsor when a safety-driven change requires expedited implementation with approval pending).
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