Legal and Contract Consultation

Key to the conduct of clinical trials is the speed and thoroughness with which contracts between Montefiore and the sponsor are negotiated and signed. Master agreements are encouraged. Many aspects of the initiation of a clinical trial can occur simultaneously and do not have to wait for other elements to be finalized. For example, contract negotiations can occur prior to IRB review. Essential contract elements (i.e., confidentiality agreements, indemnification statements, evidence of sponsor insurance, and financial arrangements) can be obtained concurrently with other administrative steps.

The OCT is committed to facilitating the legal/contracting process to the benefit of potential subjects, investigators and sponsors. The OCT has the expertise to review most sponsor-initiated contracts expeditiously and communicate directly with the sponsor. The OCT also has sample documents if so requested by sponsors who would like MMC to initiate the contracting process or to suggest its required contract language. The investigator is regularly apprised of the progress of contract negotiations and is advised not to sign contracts without consulting the OCT.

Confidentiality agreements must be reviewed and approved by the Director of the Office of Research and Sponsored Programs.

Budget Preparation Assistance and Financial Accounting

Research budget development is the responsibility of the individual department(s) involved, however, the OCT is prepared to assist investigators in developing budgets that are realistic and fair for all parties. Upon award of a clinical trial contract, the investigator is required to establish an account for that trial through the ORSP from which all trial expenses can be withdrawn. Monthly reports are provided to investigators/administrators through the SAP system.

The indirect or overhead rate for clinical trials at Montefiore is 25% of total direct costs.