STEPS TO STUDY ACTIVATION
Submit to CTSI Scientific Review Committee
Prior to Institutional Review Board (IRB) review, Indiana CTSI Scientific Review Committee (SRC) approval is required for new studies that meet the following criteria or when deemed necessary as an IRB provision for approval:
- Research that requires convened biomedical IRB review (full Board) or is considered flexible expedited categories 400(b) and/or 700(b), and
- Has not undergone a previous peer-review process. Peer review may include review of the protocol by an external funder, such as a federal agency or established not-for-profit research foundation, or protocol development by a commercial sponsor, such as a pharmaceutical or medical device company. Indiana CTSI SRC review is not required for studies that undergo IU Simon Comprehensive Cancer Center (IUSCCC) SRC review.
Investigators should send protocols to the Indiana CTSI Scientific Review Committee directly at ctsisrc@iu.edu prior to IRB submission. The Indiana CTSI SRC will review new studies within two weeks. IRB review will not occur until after SRC review and approval.
Resources
Visit the Indiana CTSI SRC website for more information about the Indiana CTSI SRC review criteria and process.
IU Simon Comprehensive Cancer Center (IUSCCC) Additional Information
For Cancer Center Trials (studies involving cancer patients):
IU Simon Comprehensive Cancer Center (IUSCCC) Scientific Review Committee (SRC) evaluates all research that involves cancer patients or that utilizes resources or space within the cancer center. Visit the Cancer Center Scientific Review Committee (SCR) for Oncology page for more information about the cancer center SRC process.
Contacts
For questions contact the Indiana CTSI SRC at ctsisrc@iu.edu.
Submitting your study to the CTSI Scientific Review Committee is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.