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Services Offered by the Office of Clinical Trials
The OCT is available to help sort through the maze and break down barriers that investigators and research staff often come up against when filing submissions, initiating and conducting a clinical trial.
Our experienced team can help you identify and implement the services you will need to be successful:
- Budget design and negotiation
- Contract negotiation
- IRB submission
- Subject recruitment and retention planning
- Invoicing for services rendered
- Regulatory documentation
- Data storage
Important Note Concerning the IRBs: The Einstein Human Research Protection Program (HRPP) promotes and protects the rights and welfare of all human research participants. Affiliated organizations include all of the colleges and schools of Yeshiva University, Montefiore Medical Center, Jacobi Medical Center and North Central Bronx Hospital. Einstein's two IRBs (formerly known as the Committee on Clinical Investigations (CCI) and the Montefiore Medical Center IRB) facilitate excellence in human research by extending personalized guidance and support to the research community through timely and high quality service, education, review, and monitoring. Two IRB meetings are held monthly to review full board items while all other transactions are reviewed upon receipt on an ongoing basis. The IRB manager is David Wallach, CIP; the chairs of the IRB committees are Michael Reichgott, MD, PhD (East Campus) and Shlomo Shinnar, MD, PhD (West Campus). In addition, some studies fall under the jurisdiction of the Biomedical Research Alliance of New York (BRANY) IRB.
Definition of an Industry Sponsored Clinical Trial
Industry sponsored clinical trials are a subset of clinical research and must include both of the following factors in order to qualify for such a clinical trial’s reduced rate of institutional overhead:
The objective of the study is either:
-testing of drugs, devices, diagnostics, treatments, interventions, or preventive measures including testing for an unapproved indication OR
-data collection to increase knowledge that would lead to enhanced safety and efficacy of a specified drug or device; and
The study must involve contact with patients or retrospective review of medical records, clinical data or specimens obtained from contact with humans.
For clinical research grant applications other than industry - sponsored programs (i.e., Federal, NIH, etc), contact your departmental administrator and/or the Institute for Clinical and Translational Research (718. 430.3607) for guidance and assistance with budget development and compliance review. The latter grants will be managed by Einstein Grants Administration, regardless of the PI’s location or payroll.
Issues to consider when you want to participate in a device trial:
- Is the device experimental (IDE and Category B designation needed) for the population or indication?
- Is the Sponsor providing the device at no cost or does it have to be purchased?
Billing Compliance should be contacted to answer:
- Do appropriate billing codes exist in the hospital system for this device?
- Can / should the device be billed to insurance/Medicare?
The OCT will help investigators holding or needing an IND or IDE at any stage of an investigation. Specifically, the IND/IDE assistance program will:
- Assist in the determination if there is a requirement for the submission of an investigator-sponsored IND or IDE.
- Provide education to investigators regarding the regulatory responsibilities as the sponsors of INDs or IDEs.
- Provide guidance in the preparation and submission of sponsor-investigator IND or IDE requirements.
- Provide regulatory assistance during FDA inspections of sponsor-investigator clinical trials.