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, SRC and RMG. 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.
How to Secure All Regulatory Approvals
In preparation for study activation, the PI and research team first assess all compliance requirements and then initiate any processes required to obtain the necessary approvals. The PI and/or designee:
- begins the IRB approval process;
- submits minimum documents to Clinical Trial Research Management Group Intake;
- completes all University required training (PI training and Good Clinical Practice/CITI training);
- works with appropriate University and FDA offices to address regulatory requirements and approvals if necessary; and
- accurately fills out the Proposal Development Routing Form (PDRF), which captures conflict of interest (COI), General Data Protection Regulation (GDPR) and other information.
Concurrent submission by the research team to IRB, RMG and SRC (if applicable) expedites the review process.
CT RMG initiates additional reviews if necessary, such as those required for significant risk device studies. The CT RPM notifies the research team of the need to obtain a local Medicare intermediary approval of an IDE trial and provides the applicable forms with instructions. Hospital Patient Financial Services manages this part of the process and distributes FI approval letters.
Stanford Internal Resources
- PI Waivers
- Institutional Review Board (IRB)
- Scientific Review Committee (SRC)
- Spectrum - Clinical Trials Disclosure (ClinicalTrials.gov)
- Spectrum - Regulations, Policies, Resources
- Medicare Preauthorization Forms (see attachments below)
- FDA - Clinical Trials and Human Subject Protection
- FDA - Investigator-Initiated Investigational New Drug (IND) Applications
- FDA - Investigational Device Exemption
- Medicare Coverage Related to Investigational Device Exemption (IDE) Studies
- Fiscal Intermediary - Noridian
- European General Data Protection Regulation (GDPR)
- Conflict of Interest
- Policy on Faculty Conflict of Commitment and Interest RPH 4.1
- University School of Medicine Conflict of Interest Policy
- PI Eligibility and Criteria for Exceptions - RPH 2.1
- Human Subjects and Good Clinical Practice Training Policy
- Human Research Protection Program (HRPP)