Required NIH RAC # Approval Date Reviews and FDA IND # Approval Date Approvals Required PI CV Responses to Appendix M I MVI Attachments – submitted to NIH RAC Recombinant or Synthetic Nucleic Acid Regulatory Elements in the Function of Construct (i.e. promoters, Gene Source(s) Gene Name Insert/Protein enhancers, polyA, replication (Genus, Species, Expressed origins, terminators) Strain) 1. 2. 3. Plasmid Viral Vector Type Naked DNA or RNA Other: Specify IV Vector IM Administration IP Route Other: Specify Vector Genus, species N/A, not plasmid or viral Vector Source Description Provide Technical Name Name of Vector Provide reference or source OR N/A, not commercially available Replicating Vector Replication defective Characteristics Integrating Oncolytic
Required Reviews and Approvals NIH RAC # Approval Date FDA IND # Approval Date Required Attachments PI CV Responses to Appendix M I – MVI submitted to NIH RAC Recombinant or Synthetic Nucleic Acid Gene Name Gene Source(s) (Genus, Species, Strain) Function of Insert/Protein Expressed Regulatory Elements in the Construct (i.e. promoters, enhancers, polyA, replication origins, terminators) 1. 2. 3. Vector Description Vector Type Plasmid Viral Naked DNA or RNA Other: Specify Vector Administration Route IV IM IP Other: Specify Vector Source Genus, species N/A, not plasmid or viral Name of Vector Provide Technical Name Provide reference or source OR N/A, not commercially available Vector Characteristics Replicating Replication defective Integrating Oncolytic
Form%20Q-1.docx