Regulatory and Compliance Reviews

For the purposes of clinical trials, regulatory approvals include any approvals by government or health authorities regarding any research that includes human subjects. Additional approvals will be necessary if the research involves the use of an FDA regulated product.

The Principal Investigator (PI) is responsible for assessing and addressing all applicable regulatory approvals for the study. The study team initiates the review processes through Institutional Review Board (IRB), Stanford Scientific Review Committee (SRC) and Research Management Group (RMG) submissions.

The majority of clinical trials are subject to Food and Drug Administration (FDA) regulations and human subject protection laws. The study team should include FDA approval letters for externally sponsored projects in the initial submissions to IRB and SRC. PI-initiated studies also may involve filings with the FDA prior to IRB review and approval.

The IRB evaluates and approves all protocols involving human subjects research.

The SRC provides peer review of all protocols involving cancer patients.

With a few exceptions, significant risk device trials conducted under an Investigational Device Exemption (IDE) require additional approval from a local Medicare fiscal intermediary (FI).

The Clinical Trial Research Process Manager (CT RPM) verifies alignment of submission information and confirms that all required approvals are secured prior to contract execution.