Office of Human Research Affairs

Montefiore-Einstein Research Compliance

The mission of the Montefiore-Einstein Research Compliance Group is to promote compliance with institutional research policy, federal research regulations, good clinical practice and ethical standards as they pertain to clinical research.

On this page you will find key research policies, guidance documents, templates and other resources.

We encourage you to contact us with any research compliance questions. For example, we can answer questions and provide guidance about the following:

  • Setting up and maintaining your regulatory binder
  • Setting up and maintaining your subject files
  • The research informed consent process and documentation
  • Recording and reporting clinical adverse events
  • Recording and reporting protocol deviations
  • Corrective and Preventive Action Plans

Please contact the Research Compliance Group with questions pertaining to the above topics or about any of the resources and policies listed below.


Required Documentation Checklist - Regulatory Binder

Required Documention Checklist Regulatory Binder 

Required Documentation Checklist – Subject Binder

Required Documentation Checklist Subject Binder 

Subject Binder Templates:

Self Audit Tool 

Educational Materials 

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