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Resources for Industry Sponsors of Clinical Research

Mass General Brigham is committed to identifying and adhering to best practices in research grants and contracts administration, upholding the highest standards of integrity and fiduciary responsibility.
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Overview

Mass General Brigham is one of the nation’s leading research medical centers with several Harvard Medical School teaching hospitals. Research is a mainstay in our culture. A passion for learning, questioning, discovery, and furthering knowledge is part of our makeup. Our researchers push the boundaries of knowledge and advance medicine in new and innovative ways. Mass General Brigham Research Management seeks to proactively address the administrative demands on investigators by providing exceptional customer service to our distinguished research community and collaborators.

Research Management Contracting Team

RM’s Contracting Team (RM Contracting) provides centralized research contracting support to MGB’s research community. RM Contracting is responsible for drafting, reviewing, negotiating and executing research agreements with external entities on behalf of MGB member institutions, including, but not limited to, clinical research agreements with industry sponsors.

Research Management Clinical Research Budgeting Team

RM’s Clinical Research Budgeting Team provides centralized budgeting and financial services to the MGB clinical research community. Core services include the review, development, and negotiation of industry-sponsored clinical research budgets and financial terms, as well as ongoing assistance with budget amendments. Budgets may pertain to clinical trials, clinical research services, and other investigator‑related clinical research initiatives. The team also plays a key role in research billing compliance by preparing and finalizing Medicare Coverage Analyses (MCA) and coordinating required Centers for Medicare & Medicaid Services (CMS) approvals with sponsoring parties for investigational device clinical trials, when applicable.

Frequently asked questions

What is needed for RM to initiate the contracting and budgeting review processes for a clinical research agreement with an industry sponsor?

To initiate RM’s contracting and budgeting review, MGB’s principal investigator for the clinical research study needs to formally submit an agreement request to RM through MGB’s internal contracts management system called Insight. That submission must include the following documentation:

  • An editable version of the industry sponsor’s template clinical research agreement or, alternatively, the sponsor’s agreement in writing (e-mail is sufficient) to use MGB’s template clinical research agreement as a starting point.
  • The final clinical research protocol that has been, or will be, submitted to the applicable institutional review board (IRB).
  • For a sponsor-initiated study being performed under an Investigational New Drug (IND) application, a letter directly from the sponsor on its letterhead confirming FDA approval of the IND, the IND number on the study protocol, or the FDA approval letter. For an investigator-initiated study being performed under an IND application, the FDA protocol may proceed letter is required.
  • For a sponsor-initiated study being performed under an Investigational Device Exemption (IDE) or PreMarket Approval (PMA)/510K (carotid stent trials only), the FDA approval letter. For an investigator-initiated study being performed under an IDE or PMA/510K, the FDA protocol may proceed letter is required.
  • The draft budget prepared by the industry sponsor, if applicable.
  • Internal pricing documentation from applicable MGB research support teams, if any and as required.
Can clinical research contract and budget review occur before or in tandem with IRB review of the study?
Yes. Both clinical research contract and budget reviews may occur before or at the same time as IRB review of the study. IRB approval of the study is not required to initiate RM’s contracting and budgeting review processes.
What is RM’s timeline for completing its initial review of an industry sponsor’s clinical research agreement and budget?
RM Contracting aims to complete its initial contract review within ten (10) business days after receiving and accepting the complete Insight submission for the agreement. RM Clinical Research Budgeting aims to complete its initial budget review within fourteen (14) days after receiving and accepting the complete Insight submission. Meeting this target is dependent upon study complexity (e.g., MCA requirements), accurate submission documents, and timely feedback from MGB’s principal investigator/study team.
What is RM’s timeline for executing a clinical research agreement with an industry sponsor?
RM aims to execute the agreement within sixty (60) to seventy-five (75) days after receiving and accepting the complete Insight submission for the agreement. Meeting this target is dependent on study complexity, as well as the responsiveness of the sponsor (including sponsor’s contract research organization, if applicable) and MGB’s principal investigator/study team.
Does MGB allow for the utilization of external negotiation portals?
Due to the high volume of studies being reviewed by RM, use of external negotiation portals for industry-supported clinical research agreements and/or budgets is not feasible.
What is MGB’s institutional indirect cost rate (IDC) for industry clinical research?

The current indirect cost rate for industry supported clinical research is assessed at 35% on a total direct cost basis. All costs included within the budget are subject to indirect costs, with the exception of certain institutional fees including Clinical Trials Office Fees, IRB Fees, and Medicare Coverage Analysis Fees. All other site-level fees, subject remuneration & reimbursement, and fees that some sponsors may consider “pass-through” costs such as subcontractor expenses, advertising, study team travel reimbursement, etc., are subject to this indirect cost rate and base.

Please find documentation related to our current indirect cost rate below

What standard institutional fees may apply to industry supported clinical research?

Institutional fees that may apply to industry-funded research are listed below. Please note this is not an exhaustive list and all fees listed below are non-negotiable. When available, a link is provided to the various documentation letters for your convenience. Documentation may be provided during study/project-specific negotiations, if not included here.