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Revising trial documentation

You may periodically need to revise the documents associated with a trial, including Help documents and sponsor-provided documents.

To implement a new document version:

  1. Update the files that make up the document.
  2. If any link counts change, or if you add or remove a file from the document, update the XML file in which you specify the document definition.
  3. Load the new or updated document files into the database using the MedML Installer to process the document definition XML file.
  4. If you have made any changes to CRF Help, use the MedML Installer to reload into the database the definition of each Form to which the changed help text applies.
  5. Create a new StudyVersion to include the updated document by changing the VERSIONDESCRIPTION attribute of the StudyVersion definition.
  6. Associate the new StudyVersion with each site at which it will be applied by changing the VERSIONDESCRIPTION attribute of the StudyVersionSite tag to match the StudyVersion definition.
  7. Associate the updated document definition with the new StudyVersion definition by changing the VERSIONDESCRIPTION attribute of the StudyVersionDoc tag to match the StudyVersion definition.
  8. Use the MedML Installer to load the updated definitions into the database in the following order: StudyVersion, StudyVersionDoc, StudyVersionSite.

For more information, see Trial documentation and study versions.

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