Study Activation
Study activation guiadance.
Award Management
Sponsored Projects Accounting (SPA) is responsible for the post-award administration of grants and contracts received by the Icahn School of Medicine at Mount Sinai (ISMMS).
Award Setup
Award setup guidance.
ClinicalTrials.gov Registration and Reporting
REGISTRATION VIA REDCAP IS HERE!! Learn how to register your study. NOTE: PRS Review of protocol registration records from CT.gov is currently taking up to 10 business days! Please plan accordingly. Useful Informtation * ISMMS...Do you Need an IDE? IDE Applications and Maintenance
The FDA regulations state that all clinical investigations of devices must have an approved IDE or be exempt from the IDE regulations.
Do you Need an IND? IND Applications and Maintenance
Research studies that involve drugs, biologics or devices that are not approved by the FDA or studies using these products in ways that are not approved by the FDA require submission to the FDA before studies commence.
IACUC Submission
Approval from the Institutional Animal Care and Use Committe (IACUC) is required for any activity involving vertebrate animals in biomedical research, training, or teaching.
IRB Submission
Steps for submitting to the IRB.
IRB and IACUC Approvals – When Do You Need to Submit?
Guidance for when to submit to the IRB or IACUC.
GCO & Extramural Submission
Guidance for GCO & Extramural Submission