doctor Find a doctor
OR

You are here

Clinical Trial Office

Mission Statement: Clinical Trial Office

Welcome! We're here to help support your clinical and human research.

BMC Clinical Trial Office (CTO) serves as a central resource for principal investigators, study staff and departments involved in clinical research and for sponsors seeking to conduct clinical trials at Boston Medical Center. Our CTO pre-award and post-award team(s) supports and advances BMC's mission by providing leadership and expertise in Research, Finance and Administration. In fulfilling this mission, the CTO's primary functions are to:

  • Review, negotiate, and approve of protocols that are projected to be IRB: approved, expedited, or exempt AND industry or internally funded (Clinical Trial Agreement,CDA,NDA)
  • Support Grants & Contracts on protocols that include human subjects (government agency, subaward, foundation award)
  • Oversee document harmonization before final approvals: Informed Consent, Contract, Budget, and Medicare Coverage Analysis
  • Ensure accurate clinical research: billing process, charge routing, and pricing
  • Coordinate, educate, and train on clinical research requirements within research community and clinical departments.
  • Monitor and provide oversight of clinical trial account finances.

 

VelosCT is a Clinical Trial Management System (CTMS) used to manage financial, administrative and clinical research activities. The system links study status, patient enrollment, calendars, budgets, and patient status as well as provide a mechanism for budgeting, milestones, A/R management, protocol management, patient recruitment & management, query management, adverse event reporting, etc. It is primarily used for managing clinical research studies utilizing hospital infrastructure with charges posting to SDK or GE.

Getting started:

Complete the following:

If you are unsure as to whether your study should be entered in VelosCT, please first complete the MCA/VelosCT Determination Checklist Form  (or contact [email protected]). If your study qualifies for VelosCT, then proceed to steps 1 & 2, if not already completed.

  1. Watch the following Training Videos (For those who plan to administer studies in VelosCT). Use the VelosCT-Test Study for VelosCT Training Videos  when training:
  2. Please complete the VelosCT User Access Request Form if you will need access to VelosCT.

VelosCT | INSPIR-II Interface:

The aim of the interface is to help reduce some of the administrative actions required with clinical research studies. Key highlights include:

• Jump-start your new IRB protocol application directly out of VelosCT by sending 12 data fields (one-time) to INSPIR-II and receiving an IRB Protocol Number in return for your study

• Automatically receive IRB protocol status updates, NCT#, and Documents from INSPIR-II in VelosCT (it will auto-archive previously interfaced documents too)

• If your IRB protocol is ceded (e.g WIRB, CIRB, Hummingbird), that number will also come to VelosCT once it's been entered and approved in INSPIR-II (Note: ceded protocols without a corresponding INSPIR-II protocol are not part of the interface)

For more information please read: VelosCT | INSPIR-II Interface Overview and view: VelosCT |  INSPIR-II Interface Training Video .

ClinCard is a web-based reloadable debit card program used for research participant payment issuance, tracking, and reporting. Studies must have an active IRB # in order to participate.

Getting started:

It's recommended you include the statement 'participant payments will be made via a reloadable debit card' to the Informed Consent for all new and existing BMC managed projects/proposals (at the time of IRB Protocol Application or Renewal).

Then complete the following:

  1. Watch a 5-minute ClinCard Training Video 
  2. Read through the ClinCard Departmental User Manual 
  3. Complete and submit the ClinCard User Access Request Form  (no physical signatures)
  4. Complete and submit the online ClinCard *Card* Pick Up Request Form  along with attaching the ClinCard Study Setup Request Form  and supporting documents (Informed Consent, and Project Budget)
  5. After submitting these forms, a Clinical Trial Financial Analyst will get your study setup and confirm when you can start using ClinCards to pay your research participants. Questions about the ClinCard program can be sent to [email protected].

Lawson is BMCs' Enterprise Resource Planning financial system of record. It's primary functions include: reporting, online check requisitioning and purchase order creation.

Getting started:

  • You must have a Windows Operating System and Internet Explorer to use Lawson.
  • You must have a valid BMC login to gain access to Lawson. If you do not have one, please contact the BMC IT (4-4500).

To request access, go to the FIS User Access Forms page  and select from one of the three research-related options on the right:

  • LBI Reports User Request Form "Research" (for Finance Reporting).
  • LBI Report User Request Form  "Hospital and other Non-Grants" (Use this form to request the VelosCT Reporting Dashboard)
  • Lawson Requisition Center User Request Form (for creating Purchase Orders).
  • Online Check Request Authorization Form

 

Show All Hide All

Most Commonly Asked


 

If the protocol is a corporate-sponsored clinical trial and the PI received a CDA from the corporate sponsor, The CDA should be forwarded to the Contract Attorney in the Clinical Trial Office for processing. If the protocol is PI initiated and the PI is seeking funding from an outside sponsor, the PI should contact the Contract Attorney to discuss options.

 

The first step is to complete an MCA/VelosCT Determination Checklist. The questions on the checklist will allow the Clinical Trial Office (CTO) to complete an initial assessment of what type of study or trial is being contemplated and if the participants and study activities will need to be captured in our Clinical Trial Management System – VelosCT.

The CTO will provide a response to the MCA/VelosCT Determination Checklist and request that you set up your study/trial in VelosCT for management of the contract negotiation. Once the draft, or final, protocol, draft Clinical Trial Agreement (CTA), draft budget and draft ICF are uploaded, and study summary and more study details are completed, then a Study Initiation eForm should be completed. This will trigger an email notification to the CTO Inbox, and the CTO will begin the process of reviewing the documents, beginning the coverage analysis and initiating the contract negotiation.

 

The MCA/VelosCT checklist  provides the details needed for that first assessment of what type of study/trial you are interesting in being a site for, and allows us to analyze whether our CTMS – VelosCT will be utilized.

 

The coverage analysis, or Medicare coverage analysis, is a tool created to document the protocol defined clinical services and research administrative services that will occur in the clinical trial. Using the CMS Clinical Trial Policy, and the sponsor's offer, each clinical service is defined with regard to its status regarding billing to Medicare (and third party payers). The coverage analysis is an important component in the accurate and compliant billing of research clinical services.

 

To meet the requirement to oversee and accurately bill for research clinical services BMC uses VelosCT, a clinical trial management system, that allows for participants and event management. This enhances the overall level of accuracy of billing of research services and supports billing compliance.

 What is the process of getting a clinical trial agreement executed?

The staff of the CTO will efficiently process the Medicare coverage analysis, budget negotiation and negotiation of the terms and conditions of the agreement. Once both parties agree, site and sponsor, the agreement can be signed and fully executed.

 

Request a Lawson LBI user account by visiting the FIS User Access Forms page and selecting the LBI Reports option for "Research" for Finance/Grants reporting.You may also select the "Hospital/Non-Grant" option if you need access to VelosCT reports for Clinical Trials.

To run VelosCT reports, please see the VelosCT-Reports User Guide 

To run Lawson reports, please see the Lawson Reports Guide 

Epic Interface


 What is the Velos-Epic interface? What does it do?

The Velos-Epic interface is the mechanism by which data is transferred from VelosCT to Epic. Functions of the Velos-Epic interface:
  • Sends information from Velos to create a study record in Epic for research billing
  • Initiates the research billing review process by sending patient enrollment statuses from Velos to Epic
  • Updates Epic study record (e.g., NCT number, AU/Activity, etc.) when there are changes to Velos study “summary” tab
  • Updates patients’ status (e.g., Screen Failure, in Follow-up, etc.) in Epic when there are changes in Velos

 When is the Velos-Epic interface required?

The Epic-Velos interface is required if:
  • Regardless of funding source (industry, government-funded, foundation, department, etc.)
  • Protocol requires patient care: service item or intervention (prospective blood draw, laboratory services, pathology tissue processing, imaging, drug administration, physical exam – E&M, surgical intervention, etc.)
  • Regardless of pre-award management – BMC CTO, BMC Grants & Contracting, BMC Development, BU Sponsored Programs (Grants & Industry)
  • Location in services: If all services are performed at BU GCRU and investigational pharmacy services are required, then the study should be in Epic

 What do I (study team) need to do?

The research billing process is initiated by the Study team, managed by CTO, and requires Study team involvement:
  1. Study teamassociates the patient in Velos on the same day as the study visit. It is imperative to enroll subjects in Velos prior to closing the first Epic encounter/visit. This process places a hold on the patient’s Epic account for CTO charge review and will prevent research billing complications.
  2. Study team updates Velos calendar visits on time (within 24 hours of visit).
  3. Study team updates the patient status and tracks Velos visits when applicable.
  4. The CTO research billing specialist reviews Epic encounters against the Velos calendar: reviews the Velos visit and charge routing (bill to study fund, research-related bill to patient/insurance, or non-research-related bill to patient/insurance).
    • If the Velos calendar is not accurate, Study team should notify their department-assigned CTFA immediately for revisions.
  5. CTO generates reports for charges routed to research funds for Study team review. If there are no issues, the charges will be expensed via journal entry to the appropriate BMC account or invoiced for the appropriate BU IO.
    • Study team should expect to receive research charge reports on a monthly basis. A communication will be sent out to the Research Community to indicate when the Epic reports are ready. If no reports are received, this communication will act as confirmation that no charges were reviewed/posted for the period.
  6. The Epic system, either automatically or through manual edits, places applicable research modifiers on claims for charges reviewed as research-related bill to insurance.
  7. If a claim is denied, CTO reviews and determines the appropriate next steps.

General


 

Compliance Related


 Office of Human Research Affairs: FAQ's - Quality Assurance Reviews

 Office of Human Research Affairs: FAQ's - Research Participants

 

Show All Hide All

 16 


 3  


 

Show All Hide All

 8  


 3