Clinical Trial Office

Forms

•  CDA/NDA Intake Form [new]
•  CDW Services
•  CDW:Fees and Billing 
•  CTO Intake Form  
•  Research Interpreter Service Form  
•  GCRU Intake Form  
•  IPS Protocol Planning Worksheet
•  Marketing Intake Form
•  New Radiology Research Registration Form  
•  Radiology Research Step by Step Guide  
•  Radiology Research Study Form  
•  VelosCT User Access Request Form

General

•  ClinCard *Card* Pick Up Request Form 
•  ClinCard Participant Information Form (CPIF)
•  ClinCard Participant Information Form (CPIF): eSign Instructions
•  ClinCard Return Slip 
•  ClinCard Study Setup Request Form 
•  ClinCard User Access Request Form 
•  Environmental Health & Safety Forms
•  Human Subjects Forms and Guidance
•  Institutional Biosafety Committee (IBC) Forms
•  Laboratory Safety Committee Forms
•  Non-Immigration Visitors (B1, B2, or WT Visas) Form 
•  Radiation Safety Committee Forms
•  Responsible Conduct of Research Forms
•  Signature Authorization   
•  W-9 Form

VelosCT

VelosCT is a Clinical Trial Management System (CTMS) implemented at Boston Medical Center. VelosCT is used to manage financial, administrative, and clinical research activities. The system links study status, patient enrollment, calendars, budgets, and patient status as well as provides a mechanism for patient recruitment & management, study data reporting, budgeting & milestones, etc. VelosCT also plays a key role to ensure research billing compliance for BMC and BU studies utilizing hospital services and infrastructure via our Velos-Epic interface.

Getting started:

If you are unsure as to whether your study should be entered in VelosCT, please first complete the CTO Intake Form If your study qualifies for VelosCT, please complete the study submission process in the system. If you do not currently have access to VelosCT, follow the steps below.

CTO requires new users to complete two trainings for access to the system:VelosCT Basics online training and Velos-Epic Interface group training. After completing the trainings, new users can send the VelosCT User Access Request form to request access to VelosCT.

VelosCT Basics: This training covers how to use VelosCT to manage study records, participants, and calendar visits.

1. Contact CTO@bmc.orgto be assigned a VelosTest training account and obtain the necessary training materials.
2. Watch the training videos below and follow the instructions in the training materials.

VelosCT Training Video 1 Introduction 
VelosCT Training Video 2 Add a Study 
VelosCT Training Video 3 Enroll Participants & Manage Visits
VelosCT Training Video 4 Roles&Responsiblities
VelosCT Basics training slides  

Please inform CTO that you have completed the VelosCT Basics training and send the  VelosCT User Access Request Form to RIS@bmc.org.

VelosCT|Epic Interface:

This training covers the Velos-Epic interface and the research billing review workflow. When you contact CTO for the VelosCT Basics training, CTO will also sign you up for our next available Velos-Epic Interface group training. The group trainings are held monthly via Zoom. Please see the calendar at the bottom of the page for future scheduled Velos-Epic Interface trainings.

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

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)                           *Be sure to provide the Clincard FAQ Sheet  to all the participants receiving a Clincard*
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 RIS@bmc.org.

Other Related Links:

• Research Participant CPIF/W-9 Repository [Restricted Access] 
• ClinCard Participant Information Form (CPIF)
• ClinCard Participant Information Form (CPIF): eSign Instructions
• ClinCard Return Slip
• BMC ClinCard Quick Reference Guide
• BMC ClinCard Cardholder FAQ
• BMC ClinCard Reference Guide Approver Role
• BMC ClinCard Reference Guide Report Viewer
• BMC ClinCard Reference Guide Site Coordinator

What do I do if I want to speak to a company about a protocol/clinical trial?

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.

How do I get started on a clinical trial agreement?

The first step is to complete an CTO Intake Form. 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 CTO Intake Form 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.

Why do I need to do a CTO Intake Form?

CTO Intake Form  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.

What is a Medicare Coverage Analysis?

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.

Why do I need to use VelosCT for my clinical trial?

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.

How do I gain access to and run research-based reports?

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 

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 team associates 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).
5. If the Velos calendar is not accurate, Study team should notify their department-assigned CTFA immediately for revisions.
6. 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.
7. 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.
8. The Epic system, either automatically or through manual edits, places applicable research modifiers on claims for charges reviewed as research-related bill to insurance.
9. If a claim is denied, CTO reviews and determines the appropriate next steps.

Is there ClinCard documentation for participants?

Please see BMC ClinCard Cardholder FAQ

Please see BMC ClinCard Holder FAQ Sheet: Fees for ClinCard

Are there any marketing resources available?

Yes, please see the Promotional Toolkit

Compliance Related

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

Institutional Procedures

•  BMC HIPAA Information 
•  Check Request 
•  Clinical Trial Intake Form 
•  Clinical Trials Registration and Reporting (ClinicalTrials.gov)  
•  Confidentiality and Non-Disclosure Agreements 
•  Contractual Agreements-BMC Subcontractor 
•  Clinical Research Coverage Analysis Policy and Forms 
•  Facilities And Administrative Rate Guidance 
•  Grant Closeout Procedure 
•  Human Subjects Research 
•  Independent Contractor/Consultant Agr. 
•  Invoicing Industry Sponsors 
•  Material Transfer (Incoming) 
•  MCA Worksheet Devices 
•  MCA Worksheet Drugs And Services 
•  Misconduct in Science 
•  Overspending Policy 
•  Protocol Amendment Financial Management Attachment A CTO Intake Form 
•  Protocol Amendment-Financial Management 
•  Purchasing/Materials Management 
•  Record Retention 
•  Research Conflict of Interest 
•  Research Conflict of Interest Process 
•  Research Participant Compensation 
•  Residual Funds 
•  Residual Funds Form 
•  Subcontract/Consortium Agreements 
•  Types Of Clinical Research Entered Into Velos CT 

Standard Operating Procedures

•  ClinicalTrials.gov Policy 
•  Investigational Pharmacy Services (IPS) 

General

 Guidelines on Authorship 

Training

• Human Subject Training Certificates (BU Medical Campus site)
•  VelosCT-Adverse Event Log CribSheet 
•  VelosCT-Reports User Guide 
•  TriNetX Research Introduction 

General

•  BMC ClinCard Quick Reference Guide
•  BMC ClinCard Reference Guide Approver Role
•  BMC ClinCard Reference Guide Report Viewer
•  BMC ClinCard Reference Guide Site Coordinator
•  ClinCard Departmental User Manual 
•  ClinCard Training Video 
•  Create Personalized InfoEd "Smarts/Genius" Profile
•  NIH Human Subjects Training Site

Resources

•  Clinical Research Times 
•  CRRO Slides-CTO Goals 
•  Remote Monitoring Chartlink Access Workflow;
•  Research Operations Workflow 
•  Research Technology Program (RTP);

General

•  BMC Federal Tax Exempt Document
•  Mass.gov Portal
•  CDC Funding Opportunities
•  Center for Scientific Review
•  Domestic Maximum Per Diem Rates
•  Federal Rate Agreement (Patient Care Rates) 
•  NIH Award data
•  NIH Grants Policy and Guidance
•  NIH Grants/Funding Opportunities
•  NIH Institutes, Centers and Offices
•  NIH Modular Research Grant Applications
•  NIH Phone Directory
•  NSF Grants and Awards
•  Research Cores & Facilities at BU & BMC  
•  SECTION III: Glossary
•  SECTION IV: Acronyms

Contacts

Boston Medical Center - Research Operations
660 Harrison Avenue
Gambro 2nd Floor
Boston, MA 02118

For all general enquiries, please feel free to reach out to us at CTO@bmc.org 

For department related enquiries  Research Operations Directory & Portfolio Distribution