Please note that there is not a specific template requirement, however there are minimum requirements that must be included.
Minimum requirements to contractual amendments:
• Contract identifier for the amended contract
• Parties (same as in the original contract)
• Amended information (depending on the extent of changes this can be described as ”changed from… to” or described as what section is substituted).
• Signatories (same as in the original contract)
Furthermore, it may be helpful having a sequence number on the amendments if the clinical trial has a long duration and therefore may be more prone to a need for amendments.
