Office of Regulatory Affairs 6495 New Hampshire Ave, Suite 201 Hyattsvile, MD 20783 Phone: 301-560-7336 |Toll - free: 1-800-793-7175 | Fax: 301-560-7336
Essential Concepts
IRB
Historical Background
MRI IRB Review Basics
Training Requirements
Device Risk Assessment
Drug Risk Assessment
Protocol Risk Assessment
Vulnerable Populations
IC Documentation
Special Cases
IC Waivers/Exceptions
MRI IC Templates
MRI Assent Template
Levels of IRB Review
New Projects
Emergency Use
AE / SAE Reporting
Amendments
Interim Review
Annual Continuation
Termination of Research
Petitioning Disapprovals
RAC
IBC
Radiation Safety Approval
Comprehensive Review
Non-Compliance
Appeal
Research Decision Tables
Investigator
Coordinator Training
FAQs
OHRP
FDA
Resource Directory
Other web resources
FORMS: Forms/Checklists
Forms: Serious/Unanticipated Adverse Event Reporting
Expedited
Version Date
10/25/04
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