Researcher Resources
Regulations, Policies, Resources
Overview
Sponsor-Investigator Research (SIR)
The Stanford CTSA Program works in collaboration with the IRB and the Cancer Clinical Trials Office to provide education and training for investigators and research teams conducting research with INDs and IDEs held by a Stanford investigator.
Refer to the Human Research Protection Program policy manual, Chapter 5.6 for requirements for investigators who hold their own IND or IDE.
Drugs & Biologics | INDs
Investigational New Drug (IND):
|
FDA/CDER website |
| FDA forms & submission requirements (drugs) | FDA website |
| Sponsor Investigator Research (SIR): Self-Assessment Form - IND |
AID-40m |
| Regulatory Binder Table of Contents for IND studies | Sample |
| Investigational New Drug (IND) Application |
Template |
Devices | IDEs
Investigational Device Exemption (IDE) application |
FDA website |
| Investigational Device Exemption (IDE) Application |
Template |
| Sponsor Investigator Research (SIR): Self-Assessment Form - IDE |
AID-41m |
| Regulatory Binder Table of Contents for IDE studies |
Sample |
Mobile Medical Applications
| Mobile Medical Applications Information |
FDA website |
| Contact FDA | Email your MMA question directly to FDA |
| FDA Guidance "Mobile Medical Applications" |
FDA website |
| mHealth Regulatory Coalition |
mHealth Regulatory Coalition |
Expanded Access to Investigational Drugs and Devices | Emergency Use
| Emergency Use of a Test Article: Notification to the IRB | doc |
| Expanded Access to Investigational Drugs and Devices |
Guidance |
| Expanded Access to Investigational (Test) Articles | Brochure |
Stanford Policies, Regulatory Memos, Resources
| Research Related Injury (Compensation) |
Consent language |
| Research Policy Handbook (RPH) |
RPH |
| Human Research Protection Program (HRPP) | HRPP Policy Manual |
| Record Retention Policies | Record Retention Policies |
| Stanford IRB Guidances | Human Subjects (IRB) website |
| Regulations governing Human Subjects Research | Human Subjects (IRB) website |
| Privacy Policies and Guidelines, HIPAA, and Research |
University Privacy Office website |
| Dean of Research (DoR) Office | Dean of Research (DoR) website |
| Industrial Contracts Office (ICO) |
ICO website |
| Office of Sponsored Research (OSR) |
OSR website |
| Office of Technology Licensing (OTL) | OTL website |
| Research Management Group (RMG) |
RMG website |
| Stanford Center for Clinical Research (SCCR) An academic research organization within the SoM/Dept of Medicine |
SCCR website |