Day-to-Day Queries and Responses
Below we anticipate your questions and provide answers. Please contact us if your question isn't included or the answer or its answer isn't sufficient.
I’ve submitted the VelosCT User Access Request form. What is the timeline for me to gain access to the system?
After you send the VelosCT User Access Request form to Research Information Systems (RIS@bmc.org), RIS requires 3-5 business days to set up your user account.
I’ve entered my study into VelosCT. How long will I have to wait for a response from CTO?
After you complete the new study submission process (including the Study Initiation eform (VelosCT study record > Forms)), your department-assigned Clinical Trial Financial Analyst (CTFA) will respond within one business week with the next steps in the process.
I don’t have all of the required study information / documents available. Should I still create a study record in VelosCT?
This is your call. You may create the study record even if you do not have all of the required documents or information available. However, please be aware that, depending upon the amount of information missing, the CTO financial analyst (CTFA) may not be able to start working on the new study. Please also keep in mind the sooner the VelosCT record is completed and submitted, the sooner your CTFA can start their review.
I accidentally enrolled the participant to the wrong study. How can I fix this?
If you enrolled the participant to the wrong study, or enrolled the wrong participant to the study, please contact your department-assigned CTO financial analyst (CTFA). They will be able to resolve the issue with Research Information Systems (RIS). In your request, please make sure to provide the study number and participant name, MRN, or Velos-ID.
I noticed that the study calendar requires edits (visits, procedures, etc.). How can I correct the calendar?
Study team members do not have access to edit the VelosCT calendar. Please contact your department-assigned CTO financial analyst (CTFA) to edit the calendar.
I have questions or concerns regarding VelosCT. Whom do I contact?
Please contact CTO or you CTO financial analyst if you have any questions or concerns, or if you experience any issues in VelosCT.
Is there ClinCard documentation for participants?
Please see the ClinCard FAQ Sheet .Be sure to provide the ClinCard FAQ Sheet to all the participants receiving a ClinCard.
What should I do with unused or expired ClinCards?
For your team possesses unused or expired ClinCards, please complete the ClinCard Return Slip and send them back to CTO.
What should we do with the ClinCard Participant Information Form?(CPIF) once were done with them?
Once you’ve added the information to the ClinCard website, if you are able to safely store the ClinCard Participant Information Form (CPIF), then save the documents. If you are unable to safely store the document then shred it, once completed.
What happens if a participant loses their ClinCard?
The participant should immediately notify Greenphire and the study coordinator will be able to replace it for them on the website. By replacing the card in the ClinCard Portal, the old card will automatically be inactivated, rendering it unusable. Additionally, any funds remaining on the old card will automatically be transferred onto the new card.
What if a payment is made in error?
Immediately contact site support at support@greenphire.com or 215-609-4378, and Greenphire will void the payment and remove the funds from the ClinCard. However, if the funds have already been spent, there is no way to void the payment and remove the funds.
What are the participant’s responsibility when receiving a ClinCard?
The participant should receive a new ClinCard in a sealed and signed envelop and is responsible to care for and protect the ClinCard from loss, theft, or misuse. If a participant believes the ClinCard has been lost, stolen, or misused, it is their responsibility to immediately contact the ClinCard vendor: Greenphire at 866-952-3795 for support. A study member informed of a lost, stolen, or misused card should contact Greenphire and the CTO.
Do participants need a Social Security Number (SSN)?
A Tax Identification Number (Social Security Number “SSN” or Individual Taxpayer Identification Number “ITIN”) is used for 1099-MISC tax reporting purposes only. No study-specific information is shared with or sent to the IRS. Required if cumulative participant payments are expected to be $600 or more in a given calendar year to prepare for federal reporting requirements.
Can I be assigned both the Approver and Site Coordinator role for my study?
One person cannot be assigned both roles for a study in the system. You will need to assign one person as the site coordinator and another to be the approver. Please refer to the Site Coordinator and the Approver reference guides for more information on the related roles and responsibilities.
ClinCard user account questions?
Please contact BMC Research Information Systems at RIS@bmc.org.
ClinCard setup and account questions?
Please contact BMC Clinical Trial Office (CTO) ClinicalTrialOffice@bmc.org.
What is the Velos-Epic interface? What does it do?
The Velos-Epic interface connects the clinical trials management system (VelosCT) with the electronic medical record (Epic). It is the mechanism by which research-related data are transferred from VelosCT to Epic. Functions of the Velos-Epic interface enable:
- Creation of a study record in Epic for research billing
- Review of research-related clinical services for protection of patients/compliant billing
- An accurate Epic record for federal and other insurers' required claims modifications
- Updating of patients’ status (e.g., Screen Failure, in Follow-up, etc.) in Epic in relation to the Velos record.
When is the Velos-Epic interface required?
The Epic-Velos interface is required, regardless of funding source and pre-award management (CTO, SPA, BMC Development, BU Sponsored Programs) , if one or more protocol-specified services is clinical. The details are as follows, i.e.:
- The protocol requires prospective patient care: a service item or intervention (prospective blood draw, laboratory services, pathology tissue processing, imaging, drug administration, physical exam – E&M, surgical intervention, etc.)
- If all clinical services are performed at BU General Clinical Research Unit (GCRU) and investigational pharmacy services (ISP) are required, the study requires 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:
- 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.)
- Study team updates Velos calendar visits on time (within 24 hours of visit).
- Study team updates the patient status and tracks Velos visits when applicable.
- 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.
- 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.
- The Epic system, either automatically or through manual edits, places applicable research modifiers on claims for charges reviewed as research-related bill to insurance.
- If a claim is denied, CTO reviews and determines the appropriate next steps.
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 (CTA)?
The first step is to complete the CTO Intake Form. The questions on the checklist will allow us 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 (CTMS) – VelosCT.
We 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 documents are uploaded -- protocol, Clinical Trial Agreement (CTA), budget and informed consent form (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 Clinical Trial Management System (CTMS) – VelosCT will be utilized.
What is coverage analysis?
Coverage analysis (CA), sometimes referred to as Medicare Coverage Analysis (MCA), is a tool created to assess the protocol-defined clinical services (and related research administrative services) to ensure that the proper payer – insurance or sponsor – is billed Each clinical service is identified as billable to insurance as "routine" or required to be provided by the sponsor because not "routine." Further, those identified as routine are analyzed for required claims modifications as stipulated by the insurers. CA is the keystone of of accurate, compliant billing of clinical research services, protecting our patients from misbilling and BMC from false claims.
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 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.