Services
The UH Research Support Core offers comprehensive services and resources designed to facilitate every stage of the research process. With specialized expertise spanning all areas of medicine, the Core supports all phases of clinical research to ensure high-quality outcomes for investigators across our region.
UH CRC Mobile Research Unit
The Mobile Research Unit launched to the community in early 2021 and is the very first and only resource of its kind in the region. The UH CRC Mobile Research Unit has the objective of increasing accessibility to clinical research and resources. This will benefit under-represented communities and patient populations by allowing the UH CRC to increase recruitment and enrollment efforts in areas that do not have resources available by engaging rural communities and UH community sites that serve a large number of minorities. This benefits the patients and community and also benefits investigators by making clinical trial opportunities more accessible to a wider patient population by encouraging the inclusion of diversity in clinical research studies. This initiative will bring research personnel and resources directly to the participants and support recruitment and retention efforts, while also increasing efficiency and compliance.
General Research Support & Staffing
Our resources comprise a dedicated team of 40 professionals, including research nurses, study coordinators, regulatory coordinators, project managers, data specialists, and recruitment specialists. This experienced workforce is available to investigators to support every aspect of the research process.
Functioning as a “float pool,” our staff is readily deployable to conduct studies across all University Hospitals (UH) sites, non-UH locations, and external institutions. The Core possesses expertise in both pediatric and adult patient populations and is well-versed in ambulatory, inpatient, and emergency medicine settings. Staffing is available to provide around-the-clock clinical research coverage, ensuring continuous support for ongoing studies.
- Dedicated study staff with expertise in all responsibilities of protocol implementation and project management.
- Comprehensive knowledge of protocol requirements, Good Clinical Practice, and Federal regulations.
- In collaboration with the Principal Investigator and study team, manage research studies from the start-up process through study completion.
- Coordinate and conduct study visits and procedures according to protocol to ensure compliance, subject safety, and data integrity.
- Submit and maintain IRB and regulatory documents in accordance with local IRB and FDA regulations.
- Continuous protocol-specific training and education for investigators, study team, ancillary services, and applicable clinical support staff.
- Perform all activities related to clinical research studies including but not limited to study start-up, recruitment, screening participants for eligibility, obtain informed consent and assent, educate participants regarding study requirements, conduct all study visits and procedures in compliance with the protocol, collect and process specimens, and maintain complete and accurate study files.
- Protocol development and grant application support
- Assist with study budget development to ensure proper funds for all services and resources through the life of the study.
- Support for rapid study start up, implementation, and close out.
- Engage with Sponsor and representatives to coordinate and conduct site qualification visits, site selection visits, site initiation visits, routine monitoring visits, close-out visits, attend investigator meetings, and Sponsor-initiated audits.
- Ongoing communication with Sponsor and representatives to report protocol deviations and adverse events, provide screening and enrollment updates, receive protocol guidance and clarification, and to ensure study is carried out in an efficient and compliant manner
Recruitment & Retention Support
Dedicated recruitment specialists are available to investigators and study teams help meet and exceed enrollment goals and to help improve participant retention. Expertise in vulnerable populations, minority populations, special populations, and difficult-to-enroll studies.
- Study-specific recruitment consultations and assistance.
- Specialize in vulnerable populations, special populations, and difficult-to-enroll studies.
- Provide advertising and promotional campaign support through UH CRC Social Media platforms.
- Assist study teams with advertising through UH Social Media and UH Marketing.
- Community Engagement Events
- Recruitment Tables & Hubs
- Budget assistance for advertisements and promotional materials.
- Collaborate with outside organizations and vendors to bring in study opportunities to UH investigators
- Query UH EMR and systems for study feasibility and for generating identifiable potential subject lists for pre-screening logs and recruitment purposes.
- Provide subject referral services from potential subjects going through our UH Clinical Research Line and UH Research Volunteer Survey Database. Lists are sent regularly to departments with active studies.
Monitoring Services
Professional research staff available to local investigators to provide monitoring oversight to ensure subject safety, protocol compliance, and data integrity. Expertise in local and Federal regulations, reporting guidelines, hospital policies, and Good Clinical Practice.
- Oversee progress of the trial and ensure compliance through routine monitoring of regulatory documents, site files, and subject files.
- Provide support and assistance to all study sites and staff during the conduct of the study.
- Ensure all data is accurate and supported by source documentation.
- Assist with protocol-specific training (SIV, protocol amendments, etc.)
- Conduct remote and on-site review of electronic data and source data verification.
- Provide oversight to ensure subject safety and efficiency.
- Continuous monitoring of all study-related activities to ensure compliance with study protocol, institutional regulations, all applicable Federal regulations, and GCP.
- Identify and follow-up on data discrepancies and compliance issues.
- Develop root-cause analysis and CAPAs related to protocol deviations and other non- compliances.
- Ensure facilities and resources being used are adequate for conducting the trial, and that accurate records of equipment used are maintained throughout the study.
- Work with Investigational Pharmacy and study staff, as applicable, to ensure proper storage, dispensing, transportation, subject-level drug accountability, and return of investigational products are maintained and recorded appropriately.
- Prepare and distribute reports on trial status and progression.
FDA Regulatory Support
Team of seasoned regulatory professionals possessing extensive expertise in regulatory affairs pertaining to drug products, medical devices, biologics, and combination products governed by the U.S. Food and Drug Administration (FDA). Services specialize in facilitating the progression of research from non-clinical animal studies to clinical trials by developing tailored regulatory strategies, collaborating closely with study teams and investigators, preparing requisite regulatory submissions, and maintaining comprehensive regulatory documentation to ensure ongoing compliance. **UH is only one of six academic centers in the U.S. that can provide FDA regulatory services.
Pre-Approval
- Regulatory affairs consultation
- Device Risk Determination, including eCopy, submission, and FDA liaison
- IND Exemption Request, including eCopy, submission, and FDA liaison
- Regulatory Strategy Creation, Implementation, and Maintenance
- Non-Clinical Gap Analysis
- Regulatory Analysis Clinical Protocol
- Pre-IND submission and meeting, including eCopy, submission, and FDA liaison
- Designation Request, including eCopy, submission and FDA liaison
- Q-submission (pre-IDE, risk determination), including eCopy, submission, and FDA liaison
- Original IND/IDE Application (building eCopy, submission, FDA liaison)
- Creation of case report forms
- Expanded Access protocols/IND submission, including eCopy, submission, and FDA liaison
- ClinicalTrials.gov Registration
Post-Approval
- Regulatory Reporting (Annual, Current Investigators, Safety, Final Reports) including eCopy, submission, and FDA liaison
- Amendments and Supplements (New Protocol, New Investigator, Changes to Existing Protocol, General Correspondence, Information Amendments) including eCopy, submission, and FDA liaison
- Financial Disclosures
- ClinicalTrials.gov Maintenance and Final Reporting
Regulatory Writing
- Pre-Clinical Protocol
- Pre-Clinical Report
- Investigator’s Brochure
- Clinical Protocol
Biostatistician & Data Scientist Support
Biostatistician and Data Scientist support is available to UH faculty and investigators conducting clinical research at any stage of the research process. Expertise in assisting investigators in disseminating research through highly influential outlets by providing accurate and scientifically valid contributions to each project in accordance with the standards and expectations of the scientific community. Team works directly with each investigator or investigative team to assess and plan the approach to each project and maintains a consistent line of communication for the project duration.
- Statistical analysis and interpretation of clinical datasets
- Interim analyses
- Data visualization
- Scientific writing and manuscript integration
- Assistance with publication or proposal revisions
- Statistical contributions as co-investigators
- Sample size/power calculations
- Statistical plans and consultation
- Dataset preparation for analysis
Innovative Technology & Solutions
Experienced researchers passionate for driving innovations to improve operational efficiency overall experience for research staff and participants. Core will assist with creating budgets, incorporating integrations into study workflow, regulatory guidance, reconciling utilization fees, and overseeing services.
UH REDCap Twilio Integration - Automated Texting and Voice Calling Services
Implements and manages automated services within the UH REDCap® environment to support automated participant communication including participant recruitment, reminders, research surveys, and study engagement strategies.
UH ClinCard & Lyft Integration – Automated Participant Payment System
Facilitates integration of UH ClinCard (participant payments) and Lyft (rideshare transportation) services into research workflows to improve participant recruitment, experience, and retention.
Complion - Electronic Regulatory Solutions
Implements and streamlines the management of Investigator Site Files and regulatory documents for clinical trials. By digitizing and centralizing essential documents, this system ensures quick access, enhanced collaboration, and improved compliance with regulatory standards in compliance with FDA Part 11.