What does the Office of Clinical Trials need from me to get started?
In order to get started with the OCT, complete our New Study Activation Form, and send it to OCT@montefiore.org, or OCT@einstein.yu.edu along with any other study-related documents you may have.
What documents do I need to submit the IRB application?
The OCT can work with you to ensure that you have all required documents for the IRB submission. Please refer to our Regulatory Checklist.
What type of certification and/or training is required before I may begin enrolling patients for a study?
- Principal Investigators, Study Coordinators and all other research staff listed in the IRB application must complete the CITI training course. For further instructions, contact the IRB: CITI
- The Principal Investigator must complete the Montefiore Research Billing Compliance training, available on the Montefiore intranet
What is a “1572”?
A 1572 is an FDA form in which the investigator states that s/he will abide by the federal guidelines set forth in the Code of Federal Regulations for the use of drugs in an investigational setting.
Where is the OCT located?
We are located on the 8th Floor of the Moses Research Tower on the Moses campus, and on Mazer 5 on the Einstein campus.