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School of Medicine

Frequently Asked Questions: Clinical Research

First Steps for New Clinical Research/Clinical Trials

Q: VCU has been approached to be a site for a new industry initiated and sponsored study, where do we start?

A: In RAMS-SPOT, select the “Submit Document for Review” option.  Fill out the web form and upload a WORD (editable) version of the sponsor’s CDA or NDA.  Route to document to OSP for review and negotiation.  After the CDA is executed by all parties, (OSP, PI and Sponsor) the sponsor will send the study information to the PI and/or study coordinator. The PI/study team then conducts a Feasibility Analysis and initiates the SOM Submission & Planning Process for externally sponsored studies.

For assistance with activating an industry initiated study, contact SOMCT@VCU.EDU.

Q: I am developing an investigator initiated clinical research study and will be preparing an application for sponsored funding. What is required at the proposal stage?

A: Investigator-initiated clinical research protocols may not be fully developed or finalized at the proposal stage when seeking external funding.  At the time of proposal submission, at minimum, clinical research proposals must include a Compliance Documentation Checklist and a Coverage Analysis Screening form.  As appropriate, the documentation will be annotated to be in draft form, to be finalized at the time of award or IRB submission.

When clinical care, procedures, or testing will be included in your protocol, due diligence should be used in developing study budgets that will cover these costs.  Ancillary service quotes should be obtained for all known tests/procedures at the proposal stage.  For more details see “Guidance for Budget Development: Federal and Non-Industry Sponsors” here.

For assistance with developing a funding proposal for an Investigator-Initiated study, contact SOMCT@VCU.EDU.

Feasibility Assessment

Q: When is Feasibility Assessment required?

A: A feasibility assessment should be performed prior to committing to any clinical research participation.  For investigator-initiated studies, this information will be included in your proposal to the sponsor and your IRB submission. For Industry initiated and sponsored studies, documentation of a feasibility assessment is required.  For more guidance on Feasibility requirements and to access a Feasibility Checklist click here.

Q: What is required for a Feasibility Assessment?

A: For studies initiated and sponsored by industry, the PI must verify and the Department Chair (or Designee) must approve that the study meets Four Key Areas of feasibility defined by SOM. 

The SOM Feasibility Checklist is available to document the 4 Key Areas of Feasibility:

1. Scientific Merit

2. Institutional Resources: Availability of qualified personnel, equipment, space, materials, etc.

3. Recruitment, enrollment and retention plans

4. Preliminary Financial Assessment              

(Study teams may use a substitute form if it addresses the 4 Key Areas and PI & Department signatures)

Q: What if we can't answer YES to all of the Four Key Areas of Feasibility?

A: Additional justification and support must be provided by the PI and approved at the Department level for all studies that do not meet the Four Key Area minimal requirements.  Final financial feasibility will be assessed at the school-level as budgets are negotiated with sponsors.

Submission and Planning

Q: We are ready to move forward with a new study. What's next?

A:  Once you have determined that you expect to conduct a study, contact SOMCT@VCU.EDU to schedule a pre-study planning meeting and initiate the SOM Submission and Planning Process

  • For industry sponsored studies, this is at the time of site selection or sooner if you need assistance with Feasibility Assessment.
  • Clinical Research proposals that undergo a sponsor review will require final assessment of compliance documentation by SOMCT at the time or award and/or IRB submission.
  • Internally-sponsored studies should initiate the process prior to or concurrent with their IRB submission.  SOMCT is available for coverage analysis consultation as you develop your study.

 

Q: When am I required to submit my study through the SOM Submission and Planning Process?

The SOM Submission and Planning Process is required regardless of whether a study is externally sponsored or internally supported.

  • For industry sponsored studies, this is at the time of site selection or sooner if you need assistance with Feasibility Assessment.
  • Clinical Research proposals that undergo a sponsor review will require final assessment of compliance documentation by SOMCT at the time or award and/or IRB submission.
  • Internally-sponsored studies should initiate the process prior to or concurrent with their IRB submission.

 

Q: What is the purpose of the SOM Pre-Study Planning Meeting?

A: The 4 main objectives are to:

  1. Assess and document study feasibility as required.
  2. Initiate the Coverage Analysis (CA) review and documentation.
  3. Begin the initial budget review and planning process.
  4. SOMCT generates a summary of all action items to be completed in order to open the study.

 

Q: Who attends the SOM Pre-Study Planning Meeting?

A: The study team, including the PI, Coordinator, and Fiscal Administrator should attend this meeting with SOMCT administration. The meeting generally lasts about 1 hour, and the PI portion takes about 30 minutes. [When CRS is hired for coordinator or budgetary support, CRS staff may also attend as part of the study team.]

 

Q: When is a SOM Pre-Study Meeting NOT Required?

A: SOMCT will evaluate a study to determine if a meeting is not necessary in order to complete the study initiation process.  Internally supported studies requiring minimal effort that do not involve clinical billing may qualify for the SOM Abbreviated Submission process; click here for more information on submission processes.  (Examples of studies that do not require a pre-study meeting include:IRB Exempt Research, Pre-clinical Studies, chart reviews, etc.)

 

Q: What do I need to do for registry studies?

A: Registry studies should be submitted to SOMCT@vcu.edu for review and will be examined on a case by case basis, but must meet applicable submission requirements if they will be submitted for IRB Full Board or Expedited approval.

 

Q: Must I wait for the pre-study planning meeting before I start work on a new study?

A: No, experienced study teams are encouraged to begin study activation steps prior to the meeting being conducted in order to expedite the activation process as a whole.  You may begin your IRB submission, request ancillary services via RedCap, conduct a preliminary budget review, document study team effort to perform study tasks, etc. as you are able.  This will make the meeting more efficient, and expedite the study start-up process.

 

Coverage Analysis and Billing Compliance

Q: Do I need to do a Coverage Analysis (CA) and Compliance Documentation Checklist for all Clinical Research studies?

A: Yes, the Coverage Analysis Screening Form and Compliance Documentation Checklist are required for all clinical research studies.  This CA Screening Form will document which, if any, other coverage analysis forms are needed.  Other applicable CA form(s) must be completed as indicated to document all study billing compliance information.  SOMCT will send the applicable draft forms to the study team following the pre-study planning meeting.  The study team will review and complete all items as needed and submit a final Compliance Checklist and all applicable documents to SOMCT for Internally supported studies, or upload it in the RAMS SPOT submission for Externally funded studies.

Q: What if my clinical research study has no potential for any clinical billing?

A: If the study does not involve any clinical services or billing, only the Coverage Analysis Screening Form and Compliance Documentation Checklist are required.

(Examples may include: Study of data collection only, Study not conducted in VCUHS or other clinical facilities)

 

Q: How do I know which Coverage Analysis (CA) forms to use?

 

A: SOMCT will send all applicable, draft coverage analysis form(s) and other required billing compliance documents to the study team following the pre-study planning meeting.  SOMCT will work with the study team and PI to finalize these forms.  The final Coverage analysis documents must be approved and signed by the PI and SOMCT.

Q: What happens to the completed compliance packages?

For Internally sponsored studies, SOMCT will send the completed/signed packages to VCUHS.  For externally funded studies, the study team will upload required Coverage Analysis and other compliance documents as part of the RAMS SPOT submission, and OSP will then send the signed forms to VCUHS.

 

OnCore Clinical Research Management System

Q: Which studies must be entered into OnCore?

A: Any new study that is clinical research or a clinical trial which requires IRB Full Board or Expedited approval must be entered into OnCore.  SOMCT will submit all new SOM studies to OnCore on your behalf using the RedCap on-line submission. 

 

Amendments and Revisions

Q: My study is going through some changes. Do I need to notify SOMCT?

A: Yes, all protocol amendments and consent changes must be submitted to the IRB and to SOMCT.  All budget and contract revisions must also be sent to SOMCT. 

These amendments/revisions will be reviewed, and corresponding updates will be made, as required, to the Coverage Analysis form(s), budget and/or contract.  All revised documents will be distributed as applicable.  For additional information on the Study Amendment Review Process click here.