Submission, review and approval requirements for gene therapy clinical trials.
| Approval Required: | Institutional Review Board (IRB) |
| Institutional Biosafety Committee (IBC) | |
| Food and Drug Administration (FDA) | |
| Corporate Partners | |
| National Gene Vector Laboratory (If site of vector production) | |
| Review Only Required: | Recombinant DNA Advisory Committee (RAC) (Only if novel methods proposed) |
| Registration Only Required: | Recombinant DNA Advisory Committee (RAC) (If novel technology is not proposed) |
| Approval Required: | Institutional Review Board (IRB) |
| Institutional Biosafety Committee (IBC) | |
| Food and Drug Administration (FDA) | |
| Corporate Partners | |
| National Gene Vector Laboratory (If site of vector production) | |
| Review Only Required: | Recombinant DNA Advisory Committee (RAC) (Only if novel methods proposed) |
| Registration Only Required: | Recombinant DNA Advisory Committee (RAC) (If novel technology is not proposed) |