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For Investigators and Staff

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laboratory study for clinical trials

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Log into your Mass General Brigham portal to submit a completed agreement or proposal or review your deliverables or action items.

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Contracting services

The Mass General Brigham Clinical Trials Office (CTO) offers comprehensive centralized contracting services to hospitals within the Mass General Brigham system.

The CTO is staffed with Agreement Associates and Assistant Case Managers who serve as the primary intermediary with industry sponsors to provide the following services for industry sponsored clinical research:

  • Draft, negotiate, and execute agreements relating to corporate sponsored clinical research 
  • Support Academic Research Organizations (ARO) within Mass General Brigham Clinical Trials and Network Institute (CTNI), Neurology Clinical Research Institute (NCRI), Thrombolysis in Myocardial Infarction (TIMI) and the Translational Research Center (TRC)
  • Triage support for uncharacterized agreements

Financial services

The Mass General Brigham Clinical Trials Office (CTO) provides centralized financial services to select entities within the Mass General Brigham system. The CTO is staffed with financial analysts who offer the following services for industry sponsored clinical research.

The CTO is staffed with Financial Analysts (FAs) who provide final institutional budget approval for industry sponsored clinical research budget. The FAs are also available to assist with budget development and negotiation.

Please contact us for budgeting assistance.

We also provide budgeting documents and tools for you to view or download:

Information

Tools

 

The CTO will set up your industry sponsored clinical research fund once the agreement is fully executed. 

For more information, refer to the Corporate Clinical Agreement Fund Setup Guidance Document.

Any questions can be emailed directly to your CTO Financial Analyst.

Industry sponsored clinical research no-cost extensions (NCEs)

When a CTO agreement specifies a hard end date for the term, a no-cost extension (NCE) amendment is required to extend the period of the agreement. CTO will negotiate and execute the amendment with the sponsor and update the fund.

The CTO will also handle end date adjustments if no amendment is needed to extend the term.

For more information, refer to the No-Cost Extension Guidance Document, and contact your CTO Financial Analyst to initiate the process.

The CTO has regulatory specialists who provide centralized services related to Medicare clinical trial billing.

Mass General Brigham requires a Medicare coverage analysis (MCA) prior to IRB protocol activation. The analysis identifies claims that may require special handling and determines what services are allowable to bill to Medicare under the National Coverage Decision (2007). It is qualitative, protocol-specific, not a reimbursement analysis, and does not speak to private payers.

The Mass General Brigham Clinical Trials Office (CTO) prepares MCAs for select entities within the Mass General Brigham system. The CTO consults with PIs during finalization to ensure usual and customary care practices and study specific billing considerations are reflected in the final documents. For trials that require special claims handling, the PI receives a billing grid documenting the charge direction for each service and justifications for Medicare billing.

A fee of $3,500 study and $1,000 per amendment (as needed on a case-by-case basis) is charged to corporate sponsors for the preparation of an MCA if required.

Resources

For more information, email the Director of Financial Services.

Medicare may pay for care provided to subjects enrolled in Investigational Device Exemption (IDE) studies. The Centers for Medicare & Medicaid Services (CMS) requires institution and trial specific pre-approvals prior to Medicare billing on a trial.

CTO works with study teams to ensure Medicare pre-approvals are in place for these studies. Petition approvals and renewals for FDA letters dated prior to 1/1/15 are managed by the local Medicare fiscal intermediary. Petition approvals for FDA letters dated 1/1/15 or after are submitted by the sponsor for national Medicare approval.

If you have any questions about the device petition and renewal process, email the Director of Financial Services.

Note: While there is a formal CMS process for Medicare claims approval, subjects with other third-party insurance (including Medicaid) may require a separate research pre-approval. Such pre-approvals may involve disclosing the investigational nature of the device and subject participation on a trail. It is the PI’s responsibility to seek and gain these research pre-approvals where possible.

Clinical trials management systems

OnCore

OnCore is an enterprise-level clinical trial management system (CTMS). It supports study management throughout the life cycle of a clinical trial focusing on protocol and subject management, financials, and reporting. It provides a tool for departments to generate invoices and reconcile payments for industry-sponsored clinical trials.

Revenue collection for industry-sponsored clinical trials is a challenge for many research departments. OnCore Financials is a platform that combines subject visit data entered by the study team and budget information from the trial agreement to automate much of the invoicing process for financial managers. For example, completed visits and IRB reviews trigger the population of invoice review tab with associated charges, which may then be used by financial managers to generate invoices.

OnCore use is currently limited to those clinical trials that meet the following criteria:

  • Industry-funded (sponsor-initiated or PI-initiated)

  • Contract handled by Clinical Trial Office

  • Non-oncology

  • New clinical trials submitted to the IRB 

All OnCore users must complete OnCore training prior to being granted access. To begin the OnCore training process, please submit a new user access request form. Required training will be assigned to you in Mass General Brigham HealthStream.

For training inquiries, please contact our office at phsoncoresupport@partners.org.

Clinical Research Coordinators (CRCs) 

  • Responsible for subject management, including subject registration and visit tracking.

  • The CRC role is typically filled by clinical research coordinators and/or study nurses.

Financial Coordinators (FCs) 

  • Responsible for creating invoices to send to sponsors

  • Monitoring and following up on invoices submitted to the sponsor leveraging OnCore’s aging functionality

  • Reconciling sponsor payments against invoices in OnCore

  • The FC role is typically filled by a grant manager, department admin, and/or clinical research coordinator. 

Advarra Participant Payments

Advarra Participant Payments is part of the suite of clinical trial management tools offered to the Mass General Brigham research community by the Mass General Brigham Clinical Trials Office. Advarra Payments is a cloud-based application that simplifies the process of paying subject stipends. Subjects are issued a reloadable Visa card which is credited with the stipend when a visit has been completed. This is an alternative to the existing eCheck request system.

Participant Payments is simple to use. Study team members access the system via a web portal to register study subjects, assign the reloadable debit card and initiate stipend payments. The subjects’ first payment on each trial requires secondary approval, but all subsequent payments may be made with the click of a button. Payments are credited to a subject’s reloadable Visa credit card within five minutes. This offers a greatly improved subject experience when compared to other methods of payments.

Participant Payments is available for both industry and non-industry clinical trials at Mass General Brigham. For OnCore CTMS supported trials there is an integrated workflow with OnCore CTMS.  Participant Payments interfaces with Mass General Brigham OnCore clinical trial management system and automatically delivers protocol information and subject registration information for those study subjects registered into Mass General Brigham OnCore. For all other trials, there is a manual registration process for subjects.

Participant Payments has three key user roles that are defined when a Principal Investigator opts-in to use Advarra Payments for their study. Users for these roles are identified by completing the initial Advarra Payments Request Form. 

Check-in and Pay

The Participant Check-in and Pay role is responsible for subject management, including subject registration and validation of all demographics, visit check-in, and stipend payments. This role is typically filled by study coordinators and/or research nurses.

  • Responsible for checking in the subjects visit and marking the visit to be paid

Secondary Reviewer

The Secondary Reviewer role is responsible for approving stipend payments and periodic review of payment reports to confirm accuracy. This role is typically filled by a project manager, senior study coordinator, or department administrator.

  • Responsible for the validation of the subject and required demographics completion and the subject’s first stipend payment

  • Responsible for the periodic review of subjects and stipends paid leveraging Advarra Payments transaction reports 

Financial Manager

To support Mass General Brigham required financial controls, the financial manager is required to confirm protocol users, subjects, and subject payments quarterly.

  • Responsible for reviewing the subject quarterly transaction audit to validate all subjects and payments for the quarter were paid appropriately

  • Responsible for reviewing the Protocol User Access annual report to validate that all users assigned to the protocol should continue to have access 

  • Responsible for validating that all the subjects on the quarterly transaction report are complete

Upon submission of the Advarra Payments Application Request Form or the User Access Request Form, resources will be assigned to the HealthStream training needed to support their individual role. All Advarra Payments training is available as web-based training in Mass General Brigham HealthStream.

The Clinical Trials Office does not charge for use of Advarra Payments, however there are fees associated with the system vendor. These fees are subject to institutional overhead. 

Advarra Payments Fee Schedule For Industry Sponsored trials the Clinical Trials Office will endeavor to negotiate these fees into the initial sponsor budget. The CTO will not initiate amendments for these fees for studies that already have an executed Clinical Trial Agreement.

For questions about non-industry trials, please contact your post-award administrator in Research Management.

*Advarra Participant Payments Visa cards are ordered by the Clinical Trials Office and distributed to you as part of the protocol configuration. Shipping costs to your study location for the cards are additional and vary based on the number of cards ordered.

Study teams can submit a request to use Advarra Participant Payments by completing this form.

Advarra Participant Payments usage must be approved by the principal investigator. An email will be sent to the PI when the form is submitted for approval.