C. Kenneth and Dianne Wright Center
for Clinical and Translational Research

Resource Name

Resource Description

EPIC Cosmos

Epic Cosmos provides a secure, self-service platform for accessing a vast de-identified clinical dataset from Epic electronic health records across multiple institutions. It allows researchers to safely perform data extraction and analysis in a sandbox environment, ensuring privacy while expanding the pool of research subjects. By offering improved access to diverse populations and encouraging the use of de-identified data, Epic Cosmos helps enhance the scope and inclusivity of your research, providing broader insights and opportunities beyond local patient groups.

Cosmos is Not a Good-Fit Method When

-you’re interested in information that isn’t
standardly documented in the EHR across
organizations e.g., flowsheet data, mortality outside of inpatient settings
- you need identified data or require chart review
-you’re researching the interventional efficacy of Epic tools at your organization e.g., patient outcomes after implementing recently developed tools

Access instructions:
Contact VCUHS Clinical Research clinical.research@vcuhealth.org to request a Cosmos account or for more information about training.

TriNetX

TriNetX offers immediate access to de-identified clinical data from millions of patients, helping you efficiently identify patient populations, assess study feasibility, and gather insights. This accelerates trial design and recruitment, making your research more effective and streamlined.

VCU: VCU only, 2010-today, includes
CMH, 1.4 million pts, downloadable
• Research: 93 HCOs, 132 million pts,
USA+others, downloadable

Limitations
• Data are de-identified and obfuscated
• Accurate data goes as far back as 2010
• No clinical note or report-based data
• No genomic data from VCUHS (other health systems do provide it)
• Outcome: Mortality linkage is incomplete

Request access to TriNetX: https://redcap.vcu.edu/surveys/?s=AA3YYL39WT

ENACT (Evolve to Next-Gen ACT) formally ACT Network

ENACT (Evolve to Next-Gen ACT) is a clinical data platform developed as the next-generation evolution of the ACT (Accrual to Clinical Trials) Network. It enables researchers to assess patient availability and study feasibility across a national network of participating health systems by providing real-time access to de-identified electronic health record (EHR) data.

ENACT enhances feasibility assessment by:

-Supporting federated cohort discovery across multiple institutions, allowing researchers to estimate the size and characteristics of potential participant populations using standardized queries.

-Integrating structured and unstructured data using natural language processing (NLP), improving the accuracy and completeness of cohort counts.

-Leveraging interoperable data standards (e.g., OMOP, i2b2) to streamline cross-site data harmonization and reduce variability.

Access instructions:
Request access to ENACT Network: https://redcap.vcu.edu/surveys/?s=AA3YYL39WT

You must be a VCU or VCUHS faculty, staff, student, or affiliate to gain access

TriNetX vs ENACT comparison

HealthLandscape Virginia

HealthLandscape Virginia is an interactive mapping tool that enables researchers to visualize population health indicators and explore the geographic distribution of patient populations across Virginia.
Investigators can use this tool to:

-Identify regions with higher prevalence of specific conditions
-Understand community-level health disparities
-Strategically plan site selection and recruitment efforts
-Support grant applications with population data
-Explore social determinants of health in the context of study feasibility

This tool is particularly useful during the early planning phase to assess recruitment potential and ensure studies are aligned with population needs.

Data USA

Data USA is a free, open-source platform that provides comprehensive, easy-to-use visualizations of U.S. public data. It integrates data from sources like the U.S. Census Bureau, Bureau of Labor Statistics, and Department of Education to help researchers:

-Explore demographic, economic, and educational trends across states, cities, and industries.
-Support grant applications and research proposals with credible, up-to-date statistics.
-Identify population needs and disparities for community-based or health equity research.
-Generate data-driven insights for policy, planning, and outreach.
-With intuitive dashboards and downloadable datasets, Data USA is a valuable tool for contextualizing research and supporting data-informed decision-making.

Access instructions:
Visit https://datausa.io
Use the search bar to explore data by location, industry, occupation, or educational institution
All data is free to use and downloadable for research, presentations, or grant applications

Data.gov

Data.gov is the U.S. government's open data portal, offering access to over 250,000 datasets from federal agencies. It supports transparency, innovation, and research by providing free, public access to data across a wide range of domains, including:

-Health and clinical data
-Education statistics
-Environmental and climate data
-Economic and labor market trends
-Transportation, agriculture, and more

For faculty researchers, Data.gov is a valuable resource for:
-Supporting grant proposals with publicly available data
-Conducting secondary data analysis
-Exploring trends and patterns across disciplines
-Building data-driven visualizations and models

Access instructions:
Go to https://data.gov
Use the search bar or browse by topic, agency, or format
Download datasets in formats like CSV, JSON, XML, or via APIs
No login or institutional affiliation is required

ICPSR (Inter-university Consortium for Political and Social Research)

ICPSR is one of the world’s largest archives of social and behavioral science data, hosted by the University of Michigan. It provides access to curated datasets for research and instruction in fields such as:

-Public health and epidemiology
-Education
-Political science
-Sociology and demography
-Criminal justice and economics

For faculty, ICPSR is a powerful resource for:

-Secondary data analysis
-Grant proposal support
-Teaching with real-world datasets
-Longitudinal and cross-national research
-Many datasets come with documentation, codebooks, and tools for analysis.

Access instructions:
Visit https://www.icpsr.umich.edu
Create a free account using your VCU email address to gain institutional access (VCU is a member institution)
Once logged in, you can:
Search or browse datasets
Download data in formats like SPSS, Stata, SAS, or CSV
Access teaching resources and data tutorials
Some restricted-use datasets may require additional approvals or data use agreements.

Resource Name

Resource Description

Explore VCU Research

Explore VCU Research (EVR) is a searchable, public-facing platform that showcases the research expertise, scholarly output, and collaborations of VCU faculty. It is part of the RAMS (Research Administration Management System) suite and is designed to:

-Highlight faculty research profiles and areas of expertise
-Promote interdisciplinary collaboration within and beyond VCU
-Support grant applications and partnership development
-Increase visibility of VCU’s research enterprise

EVR automatically pulls data from institutional systems, including publications, grants, and academic appointments.

Access instructions:
Visit the EVR portal: https://evr.vcu.edu
All VCU faculty with active primary appointments in Banner automatically have an EVR profile 1
No login is required to browse or search the site
Faculty can request updates or corrections to their profiles through the Office of the Vice President for Research and Innovation
For training or guidance, visit the EVR training page here: https://research.vcu.edu/training/evr-training/

VCU Library

VCU Libraries is a vital resource for faculty, offering access to a vast array of scholarly materials, expert research support, and innovative tools to advance academic work. Beyond providing books and databases, the library plays a strategic role in helping researchers identify knowledge gaps and shape impactful studies.

Faculty can work with subject-specialist librarians to:

-Conduct comprehensive literature reviews that reveal underexplored areas in a field
-Use advanced search strategies and citation analysis tools to map existing research and spot missing perspectives
-Access systematic review support to assess the strength and scope of current evidence
-Leverage data services to analyze trends and visualize gaps in knowledge
-Explore emerging topics and interdisciplinary connections through curated guides and consultations

By partnering with VCU Libraries, faculty can strengthen their research design, justify the significance of their work in grant proposals, and ensure their scholarship addresses real and relevant needs in their discipline.

Access instructions:
-Visit VCU Libraries Researcher Support: https://www.library.vcu.edu/research-teaching/researcher-support/
-Schedule a consultation with a subject librarian
-Use the library’s databases, guides, and tools to explore your topic
-Attend workshops or request custom instruction sessions

VCU Library: How to write a literature review

This VCU library resource covers:
-How to organize and document your sources
-Strategies for citation management
-Citation managers tool (Zotero, EndNote, etc.) to keep track of references.
-How to format citations
-The importance of consistent documentation in academic writing.

The VCU Libraries Literature Review Guide provides structured guidance on how to document your literature search process, a critical step in conducting transparent, reproducible, and high-quality research.

This resource helps faculty:

-Track search strategies across databases (e.g., PubMed, Scopus, PsycINFO)
-Record keywords, filters, and date ranges used in each search
-Ensure consistency and rigor in systematic and scoping reviews
-Identify knowledge gaps by mapping what has and hasn’t been studied
-Prepare for publication or protocol submission, where search documentation is often required


Access instructions:
Visit the guide: https://guides.library.vcu.edu/lit-review/document

Use the provided templates and examples to:
Record your search terms and logic
Note which databases were searched and when
Document inclusion/exclusion criteria

Apply this documentation to support your methodology section, PRISMA flow diagrams, or grant applications

Literature search for research planning and identification of research problem

The article highlights the critical role of a structured literature search in developing research questions and planning studies. It explains that literature reviews are essential for assessing existing evidence, identifying gaps in knowledge, and shaping research hypotheses.

Key recommendations include using the FINER criteria (Feasible, Interesting, Novel, Ethical, Relevant) and the PICOT framework (Patient, Intervention, Comparison, Outcome, Time) to guide question formulation.

The article also:

-Outlines the types of medical literature—primary, secondary, and tertiary sources

-Describes how to search effectively using databases such as PubMed, Google Scholar, and other evidence-based tools

-Details techniques like using keywords, Boolean operators (AND, OR, NOT), and MeSH terms to refine search strategies

-Emphasizes the value of a systematic and organized approach to conducting literature searches for focused, efficient research

-Underscores the importance of using reliable databases and well-planned strategies to produce thorough, high-quality results and save time

Resource Name

Resource Description

The Basics of Grant Writing: Becoming Grant Ready

This fact sheet created by Ohio State University offers a general, funder-agnostic overview of the grant writing process, making it a useful complement to NIH-specific guidance for investigators pursuing foundation, local, or non-federal funding. It frames grant writing as roughly 80% planning and 20% writing, stressing that a clear mission, program goals, activities plan, staffing, timeline, budget, and outcome measures should be established before searching for and approaching funders. The guide also walks through practical steps such as vetting whether grant funding is truly the right approach, researching and building relationships with funders, crafting a concise project pitch, and carefully following each funder's specific guidelines, formatting rules, and attachment requirements.

The Grants Learning Center provides structured guidance and educational materials on the full federal grant lifecycle, including “Grants 101,” eligibility, policies and regulations, key terminology, grant-making agencies, and common grant systems. It also offers grant-writing tips, tutorials, applicant training videos, FAQs, and information on reporting, monitoring, and avoiding grant fraud, making it a useful starting point for investigators who are new to federal funding or want to strengthen their proposal development skills.

NIH Grant Basics and Need-to-Know Resources video

This 37-minute video, part of the NIH Virtual Grants Conference, provides a comprehensive introduction to the NIH grants process. It covers where to begin, how to find funding opportunities, and what tools and resources are essential for success. Topics include types of NIH grant programs, the application and submission process, post-review and award procedures, and post-award monitoring. The session is ideal for early-career researchers and administrators seeking to understand the full lifecycle of NIH funding.

 NIH Grants Process Overview

 The NIH Grants Process page provides a comprehensive overview of each step involved in securing and managing NIH grants, from planning and application to award and post-award reporting. Key stages include preparing to apply, writing and submitting the application, peer review, award decisions, and ensuring compliance through post-award reporting.

NIH Grants Process: A Brief Walk-Through for Beginners

 NIH Grants Process: A Brief Walk-Through for Beginners" provides an introduction to the NIH grants process, covering essential steps from identifying funding opportunities to managing awards. It is designed to guide new applicants through the NIH's procedures and requirements, making it easier to navigate the complexities of grant applications.

Resource Name

Resource Description

Whetting Your Appetite For Research- Show Me The Money: Identifying Appropriate Funding Opportunities

This webinar is designed to help researchers identify the right funding opportunities for their projects. The session provides valuable guidance on how to search for and evaluate different funding sources, such as government agencies, private foundations, and industry partners. It covers how to match your research goals with the right funding programs, giving researchers the tools to focus their efforts on grants that are most likely to align with their expertise and project scope. The webinar also offers tips for staying updated on new funding opportunities, helping researchers navigate the often overwhelming landscape of available grants.

VCU login required

VCU Office of the Vice President for Research and Innovation – Funding Opportunities

- Central hub for identifying both internal and external research funding opportunities at VCU
- Includes information on institutional programs (e.g., Endowment Fund, Wright Center Translational Science Pilot Grants) as well as curated external grant listings
- Investigators are encouraged to start here to explore current mechanisms, deadlines, and eligibility
- Updated regularly to reflect available resources across departments and centers

Pivot (ProQuest)

A comprehensive, searchable database of external funding opportunities across all disciplines — federal, foundation, corporate, and international sponsors. Users can create profiles, save and track searches, and receive alerts for relevant grants, awards, and fellowships.

Access Instructions: Visit the Pivot portal and log in with your VCU credentials (or register with your VCU email). Set up profile preferences and save searches to receive customized funding alerts.

Simpler.Grants.gov provides an improved, user-friendly way to search Grants.gov for federal funding opportunities across agencies, using enhanced keyword search, filters, and redesigned results to help investigators quickly identify relevant opportunities. Users can explore active, forecasted, and archived opportunities and then link directly to Grants.gov to begin the application process.

Resource Name

Resource Description

- Provides a facilitated, multidisciplinary consultation during the early-to-mid stages of grant development, bringing together mentors, subject-matter experts, and Wright Center staff (biostatistics, clinical research, informatics, community engagement) to review a project.

- Specifically addresses refinement of specific aims and measurable outcomes, along with hypothesis development, study design, recruitment feasibility, and data analysis planning.

- Offered at no cost; participants receive collaborative expert feedback, a written summary of recommendations, and a recording of the session.

- Best suited for investigators with an identified grant mechanism and a submission deadline roughly six months out; requests should be submitted 4-6 weeks in advance and should include a draft specific aims page, description of feedback needed, and suggested expert reviewers.

- Not intended for submission-ready applications (see Mock Study Section instead) or for purely statistical/methodological questions (see Biostatistics Consultation instead).

- Provides official NIH guidance on crafting the Specific Aims attachment within the Research Plan.

- Explains how aims should summarize hypothesis-driven goals and expected outcomes and collectively answer the central scientific question.

- Emphasizes drafting aims early, seeking mentor feedback, focusing on goals and impact rather than listing experiments, and proposing a feasible set of related aims for the project period.

- NIH program officers discuss writing effective Specific Aims and Research Strategy sections for R01, R03, and R21 applications.

- Distinguishes Specific Aims (a one-page summary that "sells your science") from Research Strategy (the full rationale and experimental plan) and recommends drafting Aims first.

- Describes a strong Aims page as a cohesive scientific story with interrelated (not interdependent) aims, not a list of experiments.

- Notes the Aims page is the most widely-read section and is often shared across NIH program staff.

- Flags common pitfalls: omitting key prior work, underexplaining data analysis/interpretation, and assuming significance is self-evident.

- Encourages reaching out to NIH program officers early when developing aims.

- Provides handouts that identify eight recommended elements for writing concise and compelling Specific Aims pages.

- Includes annotated examples and color-coded templates to help investigators verify that key elements (clinical and scientific significance, innovation, hypotheses, preliminary data, and expected impact) are present.

- Designed as a practical tool for investigators, mentors, and faculty development programs to support aims-page drafting and internal review.

OVPRI's Research Development Team supports investigators across the full grant life cycle, from refining early project ideas and identifying funding opportunities to building collaborative teams and developing competitive proposals. The team assists with narrative sections such as Specific Aims and Research Strategy, including interpreting funder guidelines, drafting language, and editing proposal drafts, and encourages investigators to reach out early so aims pages can be strengthened before internal and external review.

How to access:

Click here to request services

Resource Name

Resource Description

Grant Writing Academy provides hands-on training and expert guidance to improve grant writing skills and increase proposal success rates.
The Grant Writing Academy is an educational resource designed to equip researchers with the skills and knowledge necessary to successfully write grant proposals. It typically offers a series of workshops, courses, or seminars that cover the entire process of writing grants—from understanding funding agency priorities to developing a strong narrative and budget. By attending the academy, researchers gain insight into best practices for writing compelling proposals, how to align their research objectives with funding priorities, and how to present their ideas in a clear, persuasive manner. This resource helps researchers avoid common pitfalls and significantly improves their chances of securing funding.

Grant Academy is offered twice per year. Each cohort will consist of 12-15 faculty participants. Applicants need to be available to consistently attend all cohort workshop sessions.

 OVPRI Proposal Writing Guide

OVPRI Funded Proposal Samples.

Mock Study Section (review service)

Kaltura: Wright Center Grant Writing Series

The Wright Center offers a recurring series of virtual grant seminars in which faculty experts discuss and answer questions about National Institutes of Health, National Science Foundation, Department of Defense, and other federal grant mechanisms. Topics include responding to grant critiques, incorporating rigor and reproducibility into NIH applications, and other key components of competitive grant writing and resubmission strategies.

To learn about upcoming Kaltura grant writing sessions, visit the Wright Center’s events calendar and to the Wright Center’s newsletter for updates.

VCU OVPRI Budget Resources

Budget and Financial Tools:

-Cost coverage analysis forms (for devices and non-devices) to determine allowable costs and funding eligibility

-Administrative fee letter for industry-sponsored trials, clarifying fee structures

-Study-Related Templates and Logs:

-Research compensation log

-Screening and enrollment log (for budgeting participant-related expenses)

Research Systems:

-RAMS (Research Administration Management System) for budget entry, tracking, and management

Training and Forms:

-OVPRI training opportunities related to budgeting

-Budget-related forms and guidance documents to aid accurate and compliant budget preparation

SciENcv (NIH Biosketch Tool)

SciENcv is a free, NIH-required online tool for creating and certifying biosketches for NIH, NSF, and other federal grant applications. It auto-populates fields like education, employment, and publications (often pulling from ORCID or eRA Commons), standardizing the biosketch format and reducing duplication of effort across applications.

Resource Name

Resource Description

Overview of Sponsored Program Life-cycle at VCU

Note: At VCU, all principal investigators must submit their proposals in RAMS‑SPOT for internal review and routing, and all finalized proposals are submitted to sponsors by the Division of Sponsored Programs (DSP).

This diagram provides a high-level overview of the full sponsored program life cycle at VCU, from initial idea development and proposal preparation through submission, award setup, project management, and closeout. It helps investigators and research administrators see how proposal development, budgeting, compliance, and post‑award activities fit together within VCU’s processes and offices.

VCU Proposals & Awards (Division of Sponsored Programs)

The Proposals & Awards site is VCU’s central hub for preparing, routing, submitting, and managing sponsored grant and contract applications.

- Outlines the full sponsored project lifecycle (pre‑proposal, proposal, pre‑award, award, and post‑award) and how each phase is handled at VCU.

- Links to the Sponsored Project Navigator, which provides step‑by‑step guidance for assembling and submitting proposals through VCU, including RAMS‑SPOT routing and internal review.

- Provides access to required institutional forms and templates (e.g., budget templates, PI eligibility forms, subrecipient commitment forms, biosketch templates, and other standard documents).

- Clarifies roles and responsibilities for PIs, departmental research administrators, and central offices in the proposal and award process.

- Highlights internal proposal submission deadlines, routing expectations, and review timelines to support timely and compliant sponsor submissions.

- Offers policy and compliance guidance related to sponsored projects, helping investigators align applications with university, sponsor, and federal requirements.

Note: At VCU, all principal investigators must submit their proposals in RAMS‑SPOT for internal review and routing, and all finalized proposals are submitted to sponsors by the Division of Sponsored Programs (DSP).

Proposal Submission in RAMS-SPOT- Responsible Party Diagram

This one-page workflow diagram illustrates the proposal submission process in RAMS‑SPOT and clarifies who is responsible for each step, from initiating the funding proposal through school/department review to Division of Sponsored Programs (DSP) submission to the sponsor. It is a quick visual reference for PIs and research administrators to understand roles, routing order, and key handoffs during proposal submission.

VCU Division of Sponsored Programs “Navigator” tool

The Sponsored Project Navigator is an online map of VCU’s sponsored project processes, organized by phase (pre‑proposal, proposal, pre‑award, award, and post‑award). It helps investigators and research staff quickly find the specific guidance, forms, and contacts they need based on what they are working on—whether they are preparing a new funding proposal in RAMS‑SPOT, negotiating an award, or managing post‑award changes.

- Organizes VCU’s sponsored project information by lifecycle phase (pre‑proposal, proposal, pre‑award, award, and post‑award).

- Helps investigators and research administrators locate phase‑specific guidance, required forms, and key contacts.

- Includes links to RAMS‑SPOT workflows, submission diagrams, and policy pages to support compliant proposal submission and award management.

VCU RAMS SPOT Getting Started – Administrative Actions Type Guide

This PDF guide provides step-by-step instructions for initiating administrative actions in RAMS-SPOT, VCU’s Sponsored Programs Online Tracking system. It covers how to request changes such as budget revisions, no-cost extensions, and PI changes. The document includes annotated screenshots and navigation tips to help users efficiently manage post-submission administrative tasks. It is intended for VCU faculty and staff involved in sponsored project administration.

Resource Name

Resource Description

Biostatistical Consulting Laboratory

The Biostatistics, Epidemiology, and Research Design (BERD) Core at the VCU Wright Center for Clinical and Translational Research provides expert statistical support to faculty and research teams across the university. Their services are designed to enhance the quality, rigor, and reproducibility of clinical and translational research.

Services include:

-Refining research questions and hypotheses

-Study design consultation (e.g., power analysis, randomization methods)

-Statistical analysis planning

-Grant proposal support (including budgets and statistical aims)

-Data interpretation and manuscript preparation

-Training in statistical software and methods

Tip: Reach out during the early stages of your study for complimentary consultation. Initial consultations are complimentary. If BERD personnel efforts are incorporated into the grant budget, assistance with grant proposals will also be complimentary. For all other projects, fees may be applicable.

Access instructions:
Request a consultation here: https://redcap.vcu.edu/surveys/?s=RNJ38F7HTH&origin=3

Wright Center Design Studio

The Design Studio at the VCU Wright Center for Clinical and Translational Research offers investigators the opportunity to present their research ideas to a multidisciplinary panel of experts for constructive feedback. The goal is to strengthen study design, feasibility, and overall readiness for funding or IRB submission.

Sessions bring together experienced investigators, biostatisticians, community engagement experts, and other specialists to provide diverse perspectives that improve scientific quality and impact.

Services include:

Feedback on research aims, hypotheses, and study design

Guidance on feasibility and participant recruitment strategies

Input on data collection, analysis, and community engagement plans

Support in aligning projects with funding or institutional priorities

Recommendations for additional Wright Center resources and collaborations

Tip: Schedule a Design Studio early in the planning phase—ideally before submitting to the IRB or funding agency—to maximize the benefit of feedback.

Access instructions:
Submit a request here: https://redcap.vcu.edu/surveys/?s=EK3E8A39C7F874KD

The Value of Early Collaborations with a Biostatistician: How Going Rogue Leads to Bad Science

This 1-hour video emphasizes the importance of early collaborations with biostatisticians in research to avoid pitfalls that can lead to flawed scientific outcomes. It discusses common mistakes researchers make when acting independently, highlighting the need for statistical expertise in study design, data analysis, and interpretation. The talk advocates for integrating biostatistical guidance from the project's inception to enhance the quality and reliability of research findings.

VCU login required to view.

Webinar: Whetting Your Appetite For Research Series: Sample Size

This 1-hour educational webinar, part of the Wright Center’s “Whetting Your Appetite for Research” series, is led by Dr. Leroy Thacker, a senior biostatistician at VCU. The session introduces foundational concepts in determining appropriate sample sizes for clinical and translational research. It covers why sample size matters, how it affects statistical power and study validity, and what factors influence sample size calculations. The webinar is ideal for investigators in the planning phase of a study who want to ensure their research is adequately powered and methodologically sound.

VCU login required to view.

Sense of Science: Making Sense of Statistics

Making Sense of Statistics" is a practical, plain-language guide that helps readers understand and critically evaluate statistical information. It breaks down essential statistical concepts—like averages, variability, sample size, and confidence intervals—while highlighting how statistics can be misused or misrepresented in public discourse, media, and research.

This guide is especially valuable for anyone involved in developing a Statistical Analysis Plan (SAP). It equips users with the foundational knowledge needed to:

-Choose appropriate statistical methods
-Understand the implications of sample size and variability
-Communicate statistical findings clearly and responsibly
-Identify and avoid common pitfalls in data interpretation
-Justify analytical decisions with clarity and transparency

Whether you're designing a study, reviewing data, or presenting results, this guide helps ensure your SAP is grounded in sound statistical reasoning and is accessible to both technical and non-technical audiences.

Resource Name

Resource Description

VCU Wright Center Informatics Support

- Provides expert support and access to data capture, management, and analysis tools including REDCap, statistical software, and data visualization resources
- Suitable for investigators at all stages needing assistance with informatics needs related to study design, data collection, and analysis
- Offers consultation services to tailor tools and approaches to specific research projects

Data Management Planning Tools

-Explore data management systems early to design compliant and efficient data workflows
-VCU Data Management Services (DMS) supports planning for data security, storage, and sharing
-Early consideration helps align study design with technical capabilities and regulatory requirements

Resource Name

Resource Description

Required VCU Protocol Templates

These protocol templates are required for the submission of new research studies at VCU effective June 1, 2023. They are tailored to VCU’s IRB processes and must be used for all IRB submissions.

Templates include:
HRP-503 – Biomedical studies and clinical trials
HRP-503a – Social/behavioral studies (no investigational agent)
HRP-503b – Not Human Subjects Research (NHSR) determinations
HRP-508 – VCU-specific supplement to sponsor protocols

These templates are mandatory for VCU IRB submissions.

VCU login required to access documents.

Biostatistical Consulting Laboratory

The Biostatistics Consulting Laboratory (BCL) provides expert statistical guidance for researchers, focusing on study design, analysis, and interpretation of data. BCL consultants assist in drafting research protocols by advising on optimal statistical methods, sample size determination, and data analysis plans, ensuring that protocols are scientifically and statistically rigorous. This support helps ensure that research studies are properly designed to generate valid, reliable results.

Wright Center Design Studio

The Design Studio at the VCU Wright Center for Clinical and Translational Research offers investigators a collaborative opportunity to strengthen their study protocols before submission. Sessions bring together multidisciplinary experts who provide tailored feedback to enhance study design, feasibility, and overall scientific quality.

Services include:

• Review of protocol aims, design, and methodology
• Recommendations to improve feasibility and participant recruitment plans
• Guidance on aligning study elements with regulatory and funding requirements
• Feedback on data collection and analysis plans
• Connection to Wright Center resources for additional support

Tip: Schedule a Design Studio before finalizing your protocol to ensure methodological rigor and readiness for IRB or funding submission.

Access instructions:
Submit a request here: https://redcap.vcu.edu/surveys/?s=EK3E8A39C7F874KD

University of California San Francisco Clinical Trial Protocol Development

The UCSF Clinical Research Resource Hub offers resources for protocol development, including sample templates for various clinical trials. These templates help researchers meet regulatory and GCP standards. The protocols typically cover topics like study design, subject selection, efficacy assessment, adverse event reporting, and statistical considerations. UCSF also provides access to NIH protocol templates for specific research areas like interventional, behavioral, and retrospective studies.

How to develop UMN research protocols

The University of Minnesota’s Clinical and Translational Science Institute (CTSI) emphasizes that strong research protocols should be complete, comprehensive, compliant, and consistent—the “Four C’s” of protocol development. These qualities ensure regulatory readiness and smooth study execution. CTSI also offers resources like the Clinical Research Support Center, Research Navigators, and an Investigator Manual to guide researchers through the development process.

NIH-Clinical Trial E-Protocol Tool

Note that VCU OVPRI has required protocol templates here: https://research.vcu.edu/forms/ This tool is optional and supplemental—not a substitute for VCU’s required templates.

This tool provides a standardized protocol template developed by NIH and FDA for use in NIH-funded Phase II and III clinical trials conducted under an FDA IND or IDE. It ensures consistency, regulatory compliance, and scientific rigor in protocol development. Available as a downloadable Word document and online collaborative tool.

When to use this tool: Use during early protocol development for NIH-funded interventional trials involving drugs, biologics, or devices under IND/IDE oversight.

Resource Name

Resource Description

Epic Our Practice Advisory (OPA)

This tool integrates with VCU Health’s Epic system to support point-of-care recruitment for clinical research. With IRB approval, inclusion/exclusion criteria are embedded into Epic, allowing the system to identify potentially eligible patients during clinical visits. When a match is found, a secure message is sent to the research team or clinician, who can then approach the patient about study participation.

IRB approval is required for recruitment though the OPA. Your protocol should include specific details about how the OPA will be used, including privacy safeguards and whether a partial HIPAA waiver is needed. Contact clinical.research@vcuhealth.org for verbiage that needs to be included for IRB approval.

Access instructions:
For a new study: request through Intake Form.
Existing study: Contact clinical.research@vcuhealth.org for setup or questions.

ResearchMatch

ResearchMatch is a free, online, national volunteer registry that connects volunteers interested in health-related research with researchers seeking participants. It allows researchers to search for and directly message eligible volunteers, expanding access to a diverse and geographically distributed participant pool.

ResearchMatch supports both feasibility assessment and active recruitment by:

- Serving as a national, disease-neutral registry that matches interested individuals with appropriate health-related research studies.

- Providing a feasibility-only access option that does not require IRB approval, allowing teams to view aggregate registry data, estimate the number and characteristics of potentially eligible volunteers, and gauge study interest.

- Offering the , an NIH-supported, no-cost service that uses brief REDCap surveys to collect structured feedback from volunteers (or proxy participants) on planned studies, such as protocol burden, visit schedules, and recruitment materials, with analysis and actionable recommendations provided by the Recruitment Innovation Center.

- Supporting IRB-approved active recruitment, in which researchers with an approved protocol and IRB-approved recruitment language can send secure messages to eligible volunteers, extending recruitment beyond local clinics and institutions.

- Helping teams refine recruitment messaging, incentives, and study design based on participant perspectives, which can strengthen both recruitment and retention plans.

- Additional guidance for investigators is available through the ResearchMatch.org

– National Registry Project from the Recuitment Innovation Center, a researcher one-pager, tips for creating effective contact messages, researcher FAQs, and a “How to Use ResearchMatch” toolkit document, along with contact information for ResearchMatch support.

VCU Telegram

The VCU Telegram allows faculty to submit their clinical study information, making it easier to reach potential participants. By submitting details of ongoing studies, faculty can share recruitment opportunities, updates, and relevant study information with a broader audience, helping to enhance participant engagement and recruitment efforts.