A fully developed clinical protocol is the basis for both the IRB Application and the initial IND submission:
- A completed protocol must be included in the IND application. A protocol template is currently under development.
- Start development of the protocol using a protocol synopsis (see pages X and X of the protocol template). The protocol synopsis will be valuable for planning a pre-IND meeting with the FDA.
- Compile a reference list – include all published articles and unpublished reports or manuscripts cited. Collect a copy of each article or report listed.
- For approved medications, print and read the Prescribing Information. Product information should be integrated into the protocol. In addition, your safety plan should acknowledge known safety risks from the prescribing information and incorporate relevant safety monitoring into the protocol – or show why it is not relevant to the disease under study.