Recruitment Toolkit

Partner directly with a data scientist to access customized line-level or aggregate data from the electronic medical record (EMR). Ideal for studies requiring complex queries, data for grant proposals, feasibility assessments, or when the scope goes beyond what self-service tools offer.

• When to Request: 

  • When you need detailed patient-level or summary data not easily accessible via standard reporting tools
  • For feasibility or pilot data for grant submissions
  • To support retrospective chart reviews or aggregate analyses
  • When existing self-services options (ex. Epic Slicer Dicer) do not meet your needs

• Eligibility: Available to all researchers, study team members, and faculty at Case Western Reserve University, University Hospitals, Cleveland Clinic, MetroHealth, The Louis Stokes Cleveland VA Medical Center, University of Toledo, and Northeast Ohio Medical University. 

• Cost: Initial consultation is free. Data extraction or programming fees may apply depending on project scope and institutional policies.

Slicer Dicer is a self-service reporting and data exploration tool embedded in Epic. Users can quickly build queries, filter patient populations, and visualize trends for basic cohort discovery and outcome analysis, without needing advanced technical skills.

• When to Request: 
  • For exploratory analyses, such as identifying patient cohorts or trends
  • Early-stage feasibility checks
  • When you prefer to run queries independently, or need rapid answers for protocol development
  • For aggregate-level data rather than line-level export

• Eligibility: Access available to clinicians and researchers with Epic credentials and appropriate data access privileges.

• Cost: No cost to use; institutional permissions required.

Epic Cosmos is a powerful, collaborative data platform that aggregates de-identified clinical data from millions of patient records across Epic health systems nationwide. Researchers and clinicians can use Cosmos to explore large-scale, real-world health data to generate insights, validate findings, conduct feasibility assessments, and support hypothesis generation. Cosmos enables access to a diverse array of population health data, clinical trends, and outcomes, making it a valuable tool for both academic and operational research.

• When to Request: 
  • When you need to explore clinical questions or validate findings using data from a nationwide patient population 
  • For feasibility assessments and cohort identification based on broader, multicenter data 
  • To compare trends, outcomes, or prevalence across different health systems and geographies 
  • When developing hypotheses, studying rare conditions, or supporting grant proposals with high-volume data 
  • To enhance study generalizability or supplement local data sources

• Eligibility: Access available to clinicians and researchers with Epic credentials and appropriate data access privileges.

• Cost: No cost to use; institutional permissions required.

TriNetX is a federated health research network offering real-time access to de-identified clinical data from millions of patients. Great for multi-institutional feasibility analysis, patient cohort identification, and outcome studies.

• When to Request: 
  • When you need to explore cohorts across institutions
  • For feasibility or protocol development for large clinical trials
  • For analyzing real-world outcomes data across broad populations

• Eligibility: Available to all researchers, study team members, and faculty at Case Western Reserve University, University Hospitals, MetroHealth, The Louis Stokes Cleveland VA Medical Center, University of Toledo, and Northeast Ohio Medical University. Currently unavailable to researchers at the Cleveland Clinic. Cleveland Clinic researchers may partner with teams at other CTSC sites to leverage TriNetX resources. 

• Cost: Free to request and use for feasibility or cohort identification; further analyses or data sharing may require additional steps.

Epic includes integrated tools for identifying, messaging, and tracking recruitment of eligible patients. Tools like MyChart messaging and recruitment alerts facilitate targeted outreach and engagement for clinical studies.

• MyChart Messaging: Utilize a dashboard to query patients meeting your study criteria and message individual or batches of potential participants recruitment requests directly in their Epic MyChart.
• Recruitment Alerts in Chart: Patients meeting eligibility criteria for your study will be flagged as a potential candidate for their treating provider to review and solicit interest at the time of visit.

• When to Request: 
  • For studies needing rapid, electronic recruitment
  • When you want to message or flag potential study participants directly via Epic
  • To boost enrollment through patient-provider interactions

• Eligibility: Available to all researchers, study team members, and faculty at University Hospitals, Cleveland Clinic, MetroHealth, The Louis Stokes Cleveland VA Medical Center,  and University of Toledo with appropriate Epic access and recruitment permissions. Access for university study teams may be limited via their collaborating hospital. 

• Cost: Generally free to use; institutional guidance or support may incur a small administrative fee.

Access REDCap consultations and self-guided training modules to set up, manage, and optimize data collection for your study. Get help with project setup, data validation, troubleshooting, and user education for new and ongoing studies. REDCap is a secure web platform for building and managing online databases and surveys. REDCap's streamlined process for rapidly creating and designing projects offers a vast array of tools that can be tailored to virtually any data collection strategy. 

• When to Request: 
  • When launching a new study and need guidance on REDCap project setup
  • For ongoing troubleshooting, upgrades, or advanced project needs
  • To access user training for different skill levels

• Eligibility: Available to all researchers, study team members, and faculty at Case Western Reserve University, University Hospitals, Cleveland Clinic, MetroHealth, University of Toledo, and Northeast Ohio Medical University.

• Cost: Free for most consultations and self-guided training modules; complex support or custom development may incur a fee.

Use platforms like REDCap, Epic, or institutional eConsent solutions to obtain secure, electronic informed consent from study participants. Supports remote enrollment, robust tracking, and regulatory compliance.

• When to Request: 
  • For studies with remote participants or needing electronic consent
  • To improve efficiency and accuracy in consent documentation
  • For protocols requiring integration with existing EMR or REDCap systems

• Eligibility: Available to all researchers, study team members, and faculty at Case Western Reserve University, University Hospitals, Cleveland Clinic, MetroHealth, The Louis Stokes Cleveland VA Medical Center, University of Toledo, and Northeast Ohio Medical University.

• Cost: Free; additional features or customizations may have costs.

 The Biostatistics, Epidemiology, and Research Design (BERD) Core offers expert consultation and support to help investigators design rigorous, effective, and innovative research studies. Services include help with study design, sample size and power calculations, data analysis planning, selection of appropriate statistical methods, and interpretation of results. The BERD team collaborates closely with researchers at every stage, from concept development and grant writing to analysis and publication, ensuring your study is statistically sound and optimally positioned for success. 

• When to Request:
  • During the earliest phases of study design or protocol development 
  • When preparing grant applications and need assistance with statistical sections or analytic plans 
  • To determine sample size or perform power calculations When planning complex statistical analyses or need advice on the best analytic approach 
  • For help interpreting and presenting research findings for manuscripts, abstracts, or presentations 
  • Anytime you need guidance on epidemiologic methods or best practices in research methodology

• Eligibility: Available to all researchers, study team members, and faculty at Case Western Reserve University, University Hospitals, Cleveland Clinic, MetroHealth, The Louis Stokes Cleveland VA Medical Center, University of Toledo, and Northeast Ohio Medical University.

• Cost: Initial BERD consultations are free of charge for investigators at CTSC-affiliated institutions. Extended analyses, long-term collaborations, or intensive support (such as significant data management or grant-writing assistance) may incur fees, which vary by project scope and institutional policies. Cost details are discussed during the initial consultation. Up to $7,500 of funding may be covered through the Voucher Program. 

Our Regulatory and Compliance services offer comprehensive support for the ethical, legal, and procedural aspects of clinical and translational research. Investigators receive guidance for study protocol development, preparation and submission of IRB applications, regulatory strategy, FDA interactions, and ongoing monitoring to ensure compliance with local, federal, and international regulations. Expert teams help navigate regulatory requirements, maintain essential study documentation, and ensure the safety and integrity of clinical trials throughout their lifecycle.

• Local Regulatory Support
  • Protocol and study materials development
  • IRB application preparation and submission
  • Informed consent document creation
  • Regulatory guidance and strategy
  • Compliance with institutional policies and federal regulations
  • Maintenance of essential study documents
  • Reporting of events and findings to IRB
  • Assistance with annual continuing reviews, amendments, and audit responses
• FDA Regulatory Support
  • Regulatory strategy for investigator-initiated IND/IDE applications
  • Expertise in investigational drugs, medical devices, biologics, and combination products
  • Support for preclinical-to-clinical transition and regulatory submissions
  • Pre-approval and post-approval consultations
  • FDA liaison for submissions, meetings, risk determinations, and designations
  • ClinicalTrials.gov registration and ongoing maintenance
  • Regulatory writing for protocols, reports, and brochures
• Monitoring & Oversight Services
  • Trial oversight to ensure subject safety, protocol compliance, and data integrity
  • Protocol-specific training and amendments
  • On-site and remote review of data and documentation
  • CAPA (Corrective and Preventive Action) development
  • Trial status reporting

• When to Request:
  • When preparing a new study protocol or designing study-related materials 
  • Prior to IRB submission or when revising regulatory documents 
  • For studies involving investigational drugs, devices, biologics, or FDA-regulated activities 
  • During protocol amendments, annual continuing reviews, or in response to audit findings 
  • When initiating or conducting clinical trials that require ongoing monitoring and oversight 
  • Anytime regulatory strategy, compliance questions, or FDA interactions arise

• Eligibility: 
  • Regulatory support is currently offered through Case Western Reserve University, Cleveland Clinic, MetroHealth, and University Hospitals. Institutional affiliation required to utilize. 
  • FDA regulatory support and clinical trial monitoring support available to all researchers, study team members, and faculty at Case Western Reserve University, University Hospitals, Cleveland Clinic, MetroHealth, The Louis Stokes Cleveland VA Medical Center, University of Toledo, and Northeast Ohio Medical University.

• Cost: Initial consultations, protocol development assistance, and general regulatory guidance are provided free of charge to investigators at affiliated institutions. Some extended or specialized regulatory support (e.g., extensive regulatory writing, comprehensive monitoring services, or large-scale FDA submissions) may incur additional fees depending on the project’s scope and institutional policy. Cost estimates are discussed during the initial consultation.

Maximize study enrollment and retention by leveraging expert guidance, centralized volunteer databases, social media advertising campaigns, and other recruitment services. Useful for hard-to-enroll populations, optimizing protocol design, and expanding recruitment reach.

• When to Request:
  • If you’re struggling with meeting enrollment goals
  • When designing a study and want to implement effective recruitment methods
  • For large studies requiring robust recruitment infrastructure

• Eligibility: Available to all researchers, study team members, and faculty at Case Western Reserve University, University Hospitals, Cleveland Clinic, MetroHealth, The Louis Stokes Cleveland VA Medical Center, University of Toledo, and Northeast Ohio Medical University.

• Cost: Consultations and most services are free. Costs may be incurred for adding recruitment personnel to the study team or utilizing paid social media advertising campaigns. 

Access dedicated Clinical Research Units and resources for conducting patient visits, sample collection, and study operations. Brick-and-mortar Clinical Research Units and staffing are available at the Cleveland Clinic, University Hospitals, and MetroHealth. CTSC investigators are also able to utilize the UH Mobile Research Unit, a 39-foot Winnebago with 2 private exam rooms and a dedicated lab processing center, to take their studies outside of traditional clinical areas.

• When to Request:
  • When you require space, clinical support, or infrastructure for your study
  • For complex protocols needing monitored patient visits
  • To inquire about utilizing the UH Mobile Research Unit for decentralizing your study

• Eligibility: Utilization of an institutions CRU requires affiliation with that institution or collaboration with investigators at that institution. 

• Cost: Facility use may be billed at standard rates; consultation is usually free. Up to $10,000 of funding can be covered through the Core Utilization Pilot Grant. 

Advance complex studies with expert planning, multisite coordination, and tailored solutions. These consultations and studios help overcome logistical challenges, streamline startup, and provide dynamic feedback—essential for multicenter trials or innovative study designs.

• Multisite Research Services Page
• Multisite Research Planning Consultations
• Resource Utilization Studio
• Trial Innovation Network (TIN)

• When to Request: These consultation service can be requested at any time there is interest in potentially accessing research support resources across regional and national networks. Use of network resources will require additional lead time and should be requested at least two months prior to any grant or protocol submission deadlines. Services may also be requested for currently funded clinical trials.  For TIN protocol development, it will typically require at least six months for a study proposal to be developed for NIH submission. The timeline will be determined together with the Trial Innovation Network and Trial Innovation Center.  

• Eligibility: These services are available to all researchers, study team members, and faculty at Case Western Reserve University, University Hospitals, Cleveland Clinic, MetroHealth, The Louis Stokes Cleveland VA Medical Center, University of Toledo, and Northeast Ohio Medical University. 

• Cost: There are no costs for requesting or utilizing these services.

Community Engaged Research (CEnR) Services are designed to help investigators build strong partnerships with community organizations, stakeholders, and populations to ensure that research addresses community priorities, promotes health equity, and translates findings into real-world impact. The CTSC provides support for every stage of community-engaged projects, from planning and engagement strategies, to implementation, evaluation, and dissemination of results. Services include assistance with study design, partnership development, stakeholder outreach, community advisory boards, and resources for effective community engagement. 

• When to Request: 
  • When planning new research that involves, impacts, or collaborates with local communities or organizations
  • If you need guidance on building or maintaining community partnerships for your study
  • For projects that require stakeholder input, community advisory board formation, or co-design with community members
  • When seeking strategies for effective engagement, recruitment, and dissemination in diverse populations
  • To enhance the relevance, acceptance, and sustainability of your research

• Eligibility: Available to all researchers, study team members, and faculty at Case Western Reserve University, University Hospitals, Cleveland Clinic, MetroHealth, The Louis Stokes Cleveland VA Medical Center, University of Toledo, and Northeast Ohio Medical University. 

• Cost: There are no costs for requesting or utilizing initial Community Engaged Research Services through CTSC. Some extended services, large projects, or events may require additional resources, but the CTSC provides most consultation and partnership development services free of charge. Up to $7,500 in funding may be covered through the Voucher Program.