W317 Emergency Use of a Test Article

Worksheet to provide support for investigators conducting an emergency use of a test article in a life threatening situation and Designated Reviewers reviewing an emergency use of a test article in a life threatening situation. This worksheet is to be used when overseeing emergency use of a test article in a life-threatening situation.

Appendix A: Children

File attachments

This form should be used when children/wards are engaged in the research. Children are defined as individuals who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. See "Research Involving Children" for guidance.