RDRC/SHUR Resource Links
- FDA Regulations for Radioactive Material (21 CFR 361.1)
- FDA - RDRC Guidance Documents
- RDRC Protocol Review Checklist
- Guidance for Industry and Researchers - 'The RDRC: Human Research without an Investigational New Drug (IND) Application'
- FDA Form 2915 ('Report on Research Use of Radioactive Drugs - Study Summary')
- Contact the FDA Radioactive Drug Research Committee (RDRC) Staff
- NRC - Report and Notification of a Medical Event
- NRC - Risks Associated with Medical Events
- IRBMed - Standardized 'Radiation Risk' Wording (Section 6.7 eResearch Application & Section 5.1 Consent Form) *Scroll down and click on "Radiation Exposure Guide"