The following classes of documents related to the Clinical Trial - Protocol are appropriate as a basis for change for a Clinical Trial entity:

• Urgent Safety Measures as per T.I.1
  the automatically assigned file name "vti1-urgent-s-m-subst-protocol-amend-ct.pdf"
  
• Serious breach/deviation of the Protocol as per T.I.2
  the automatically assigned file name "vti1-urgent-s-m-subst-protocol-amend-ct.pdf"
  
• Non-Substantial Protocol Amendments as per T.I.3
  the automatically assigned file name "vti3-pi-prop-non-subst-protocol-amend-ct.pdf"
  
• Investigational Brochure update as per T.I.4
  the automatically assigned file name "vti4-investigat-broch-update-ct.pdf"