Home

Ancillaries Supported by the ICTR Clinical Research Units
Clinical Trials.gov Registration
Definition of a Biological Product 21CFR 600.3 (h)
HITECH Act
How can I get copies of my research compliance training certificates?
How to cite the ICTR in Publications
IND Sponsor definition
IND Sponsor-Investigator not affiliated with Hopkins
IND Sponsor Qualifications
IND Sponsor Responsibilities
IND Sponsor responsibilities regarding study monitoring
IRB Affiliation requirements
Labeling of investigational devices (IDEs) 21 CFR Sec. 812.5
Labeling of In Vitro Diagnostic Devices (IDE) 21 CFR Sec. 809.10(c)(2)(i)
NIH Public Access Policy
Orphan Disease product definition
PI's of Federal Contracts (E-Verification)
PI's with Federal Contracts (E-Verify)
Qualifications for clinical investigators at Johns Hopkins
Significant Risk Device Defined
Significant Risk Device vs. Non-Significant Risk Device Determinations
Test Page