Researcher Resources

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Regulations, Policies, Resources

Overview

Sponsor-Investigator Research (SIR)

Spectrum 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 1571 Investigational New Drug Application
  • FDA 1572 Statement of Investigator
  • Instructions for completing FDA forms 1571, 1572
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

Quicklinks