About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

For the purposes of this document, the term minor injury is used to mean any injury that does not meet the definition of a serious injury. This regulation defines serious injury as an injury or illness that:

  • is life threatening;
  • results in permanent impairment of a body function or permanent damage to a body structure; or
  • necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

For the purposes of this document, the term permanent is defined as “irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage.”

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