Regulatory Resources
Trial Activation
The CCTO provides assistance with protocol writing and study activation such as IRB, SRC, CTRU submissions; IND and IDE applications to the FDA; study budget development and negotiation for studies with industry sponsorship; and regulatory binder preparation. Once all approvals are in place, the CCTO hands off the study to the Protocol Director and study coordinator to conduct the study.
Please follow the detailed instructions below outlining the steps to opening a new cancer study.
Trial Administration