The following classes of documents related to the Investigational Medicinal Product are appropriate as a basis for change for a Clinical Trial entity:

• Decision to introduce a new IMP Prep. Prod. Chain as per T.II.1
  the automatically assigned file name "vtii1-decision-introduction-new-imp-chain-ct.pdf"
  
• Decision to introduce a new IMP as per T.II.2
  the automatically assigned file name "vtii2-decision-introduction-new-imp-ct.pdf"