Skip to Main

Review, Activate & Publish Study

Review the details and steps for seeing your study through to publication using the tabs below.

Review Study consists of:

  • Coverage Analysis (CA) - a systematic review that examines clinical trial protocols and determines the items and services to be billed to the study sponsor or the insurance company
  • Internal review of industry clinical research agreements

Required UTSW IRB Review

You must submit all research involving human subjects for review and approval to the UTSW Institutional Review Board (IRB).

Visit Human Research Protection Program (HRPP)

Estimated Duration

The duration of contract reviews varies based on your sponsor, agreement, or contract type.

View Clinical Research Timeline

How to Begin Coverage Analysis

Please adhere to the following steps for the Coverage Analysis of your study. These tasks may be completed in parallel when appropriate.

  • Manage all updates and results on clinicaltrials.gov.
  • Register your study in Velos.
  • Register your study with IRB.
  • Request a Coverage Analysis from SPA’s Coverage Analysis.
  • Review Coverage Analysis and request changes if applicable.
  • Negotiate your final budget with sponsor.
  • Approve Coverage Analysis in DocuSign.
  • Approve Coverage Analysis modifications in DocuSign, if applicable.
  • Medicare Coverage Analysis Review Fees

How to Submit Coverage Analysis

Coverage Analysis (CA) documents must be submitted either through the Velos system or loaded into the eIRB system.  To begin the CA process, the following information is required. In the event the below listed documents are not submitted at the time of the CA submission, it may result in an administrative withdrawal.

  • CA request via the “Coverage Analysis- Submitted" study status in Velos 
  • Protocol (loaded either in eIRB or in Velos) 
  • IRB application (in draft or completed state)  
  • Consent draft (loaded either in eIRB or in Velos) 
  • Budget draft (required for industry funded studies. Can be loaded in Velos or emailed to CoverageAnalysis@UTSouthwestern.edu). Final budget will be required at the time of the CA Congruency.  
  • Funding Sheet, Internal Budget or a Budget Justification Document, Statement of Work (or similar) for non-industry funded studies to be submitted, if available and applicable at the CA submission timepoint. If not, this will be required at the time of the CA Congruency.
  • FDA Investigational New Drug (IND) letter, if applicable 
  • FDA Investigational Device Exemption IDE letter, if applicable 
  • Centers for Medicare & Medicaid Services (CMS) IDE approval letter, if billing to Medicare will be done on a research device 
  • ClinicalTrials.gov Registration Number (NCT) number 
  • Complete draft Performance Site Review form (PSF for UT Southwestern must have sections 3: Location, 4: Clinical Laboratory Services, 5:  Radiology, 7:  Clinical Research Unit [CRU] if applicable)  
  • Departmentally funded studies - Chart of Account (COA) should be added to the Velos Summary tab 
  • Lab and imagining manuals, if applicable (loaded in Velos Documents Tab) 
  • Supporting documentation, such as regulatory support or peer-reviewed articles to assist with coverage determination, if applicable

When to Submit Coverage Analysis

  • Coverage Analysis must be submitted at the same time as the IRB and/or contract submission is completed, but before IRB issues approval 
  • If submission is not completed prior to IRB approval, there will be an automatic submission generated by the Velos system
  • If CA request is not submitted in a timely manner, eIRB Greenlight will be delayed, pending final CA determination 

Draft CA document is released through DocuSign prior to being final in order to assist with budget preparation. 

Once the coverage analysis draft is available in Velos, you can locate the draft under the Documents tab. 

How to Submit Your Industry Clinical Research Agreement

You can submit your contract through the eAgreements system simultaneously as the IRB full or partial application is completed. However, you may submit a contract review request before submitting your IRB application, but it at least needs to be in "Draft State."

For step-by-step assistance with submission of your agreement, by contract type, please reference the following guidance materials:

To begin the contract review process, submit the following required documents:

  • Sponsor agreement template draft
  • Coverage analysis draft submitted in Velos
  • Consent document draft (either in eAgreements or eIRB)
  • Protocol draft (either in eAgreements or eIRB)
  • Budget draft (final budget if Statement of Work (SOW) is being submitted)
  • IRB application draft

FAQ and Expert Tips

  • What is a coverage analysis and where or what are the CA fees? (PDF)

    What is a coverage analysis and where or what are the CA fees? (PDF)

  • How do I request a coverage analysis? (Video)

    How do I request a coverage analysis? (Video)

  • How do I request a coverage analysis modification? (Video)

    How do I request a coverage analysis modification? (Video)

  • Centers for Medicare and Medicaid Services (CMS)

    What does the Centers for Medicare and Medicaid Services (CMS) regulate?

    The CMS oversees the nation’s primary health care programs such as Medicare, Medicaid, and Children's Health Insurance Program (CHIP).

    They collect and analyze data, produce research reports, and work to eliminate instances of fraud and abuse within the health care system.

    The agency strives to provide a health care system with better care, access to coverage, and improved health.

    Visit CMS.gov

  • ClinicalTrials.gov

    ClinicalTrials.gov provides patients, family members, health care professionals, researchers, and the public with easy access to publicly and privately supported clinical studies on a wide range of diseases and conditions.

    When you submit your study to SPA for review, you will need to provide a ClinicalTrials.gov (NCT) number for billing purposes.

    Available Resources:

    • Disease or condition
    • Intervention (e.g., the medical product, behavior, or procedure being studied)
    • Title, description, and design of the study
    • Requirements for participation (eligibility criteria)
    • Locations where the study is being conducted
    • Contact information for the study locations

    Visit ClinicalTrials.gov

  • Coverage Analysis

    How do I request a Coverage Analysis (CA)?
    You will need to follow the steps outlined in the Velos Coverage Analysis Submission document to ensure that you submit your study accurately for review.

    How do I submit a Coverage Analysis modification?
    You will need to follow the steps outlined in the Velos Coverage Analysis Modification document to ensure that you submit your modifications accurately.

    How do I find research pricing for a service or procedure?
    You can research pricing by going to the Velos library. Choose the appropriate rate list (depending on funding and facility) and use the search function with description or Current Procedural Terminology (CPT) code.

    If my PI says a treatment is routine or standard of care, does that mean it is considered automatically reimbursable by CMS/Medicare?
    No, SPA will follow conventional care and Medicare guidelines to determine which method we will take.

    What is a Congruency Review?
    A congruency review is a side-by-side comparison of the budget portion of a proposal (grant, contract, subaward, etc.) and consent form.

    Congruency Review FAQs

    What should I do if my study has been administratively withdrawn prior to having a final budget?
    You should continue to upload your budget into eAgreements. Once you submit a finalized budget, you will need to log in to Velos and select status: Study – Final Budget Complete. The Central Coverage Analysis Group (CCAG) will review the CA draft against the final budget and informed consent form and amend CA to match.

    • If all items match, the CCAG team will provide the final CA via DocuSign.
    • If we require adjustments to the Informed Consent Form (ICF) or budget, the CCAG team will send the CA back through Velos with specific instructions, using Coverage Analysis – Congruency Corrections Pending
  • Industry Clinical Research Agreements

    Who processes Industry Clinical Research Agreements?
    The Industry-Sponsored Clinical Trial Team handles any human research agreement with industry funding. Contact the Industry Agreement team for further assistance.

    Who signs the Industry Clinical Research Agreement?
    It depends on the total budget amount. Please reference the Institutional Signature Matrix for guidance.

    Who negotiates the agreement budget?
    Budgets are negotiated directly by the Department. Please reach out to the Clinical Trials Accounting team within SPA for additional assistance. 

    How are agreements submitted to SPA?
    You can submit your agreement to SPA through eAgreements. Please reference the eAgreements Submission Guide for further instructions.

    Does my agreement need to be submitted to SPA? 
    If your study conducts human research, you will need to submit an agreement to SPA for review and negotiations. PIs and Department Chairs do not have the authority to sign on behalf of the institution. If you are unsure whether your study conducts human research, please contact SPA by submitting a ServiceNow ticket.

Taleo Training

Ask for Guidance

Inquiries reviewed and assigned within 4 hours, Monday – Friday 8 a.m. – 5 p.m.

Open a ServiceNow TicketWhich SPA Team Can Help

Leadership

Julia Spesivtseva

Julia Spesivtseva, MBA, CRCP

Director, Clinical Research Services

julia.spesivtseva@utsouthwestern.edu

Contact Us

Sarah Memon

Lead Contract Specialist, Industry Contracts

sarah.memon@utsouthwestern.edu

Once an agreement is fully executed for your research study or patient treatment, you can begin activating your study.

Study Activation Procedures

The process for activating a study varies widely from sponsor to sponsor. Your first step is to refer to your sponsor’s outlined procedures. Other steps may include:

  • Develop Standard Operating Procedures
  • Create Informed Consent
  • Undergo Affiliated Hospital review (e.g., University Hospital, Children’s Hospital, Parkland Hospital site review)
  • Create a plan on how you will enroll patients in the clinical trial
  • Ensure that the Coverage Analysis is complete, and the Agreement has been executed

Study Activation ClinCard Issues 

Recently, the Internal Revenue Service (IRS) identified an issue where some study subjects participating in clinical research and utilizing ClinCard, contained name and Social Security information that did not match data on file with the IRS. 

A mismatch can occur for a number of reasons, including data entry errors. In order to resolve this issue, the ClinCard system has been updated so that a participant's Social Security number and name must match according to IRS tax records. If there is not a match, the ClinCard system will automatically withhold 24% in taxes from each participant payment until such time as the correct data can be entered in the system. Again, this has to be done in order to comply with IRS tax regulations.  The most recent TIN ID Mismatch file may be accessed here. Please ClinResClincard@utsouthwestern.edu the Clinical Trial Finance Team with any questions or issues.  

Study Activation Contacts 

Consult with the following departments for support and guidance in activating your study.

Roles & Responsibilities

See which steps of the process Principal Investigators, IRB, SPA, and University Hospital Committees are engaged in.

View Roles & Responsibilities

Parkland Study Approval Checklist Roles & Responsibilities

Parkland Study Review Timeline

Ask for Guidance

Inquiries reviewed and assigned within four hours, Monday – Friday 8 a.m. – 5 p.m.

Open a ServiceNow TicketWhich SPA Team Can Help

Publishing your research study builds trust and accountability, protects participants, and ensures you maximize research funding. When research is open and transparent, everyone can see what is happening and the outcomes from the finished study.

What to Include in Your Study Results

Your clinical trial or study results should include the following information:

  • Participant Flow
  • Baseline Characteristics
  • Outcome Measures and Statistical Analyses
  • Adverse Events
  • Limitations and Caveats
  • Administrative Information

Reminder: Register Your Study

Registering clinical trials when they begin, providing timely updates, submitting summary results, and making this information publicly available fulfill many purposes and benefit a variety of people:

  • Fulfills ethical obligations to participants and the research community
  • Provides information to potential participants and referring clinicians
  • Decreases publication bias
  • Helps editors and the research community understand the context of study results
  • Promotes more efficient allocation of research funds
  • Helps institutional review boards (IRBs) determine the appropriateness of a research study

Ask for Guidance

Inquiries reviewed and assigned within four hours, Monday – Friday 8 a.m. – 5 p.m.

Open a ServiceNow TicketWhich SPA Team Can Help

Back-to top