Support Services and Resources
- Development of investigator-initiated protocols
- Recruitment of industry-sponsored clinical research trials/protocols
- Facilitation of study budgets and agreements
- Protocol review, development, feasibility
- Recruitment of industry-sponsored clinical research trials/protocols
- Investigator identification and qualification coordination
- Investigator meeting and site initiation attendance
- Central coordinating center and regulatory coordinating center for multi-site trials
- Conduct research team training: per site- and multi-center studies
- Case report forms and source documentation development
- Procedure set up with ancillary departments coordination
- Scheduling and conduct of study visits
- Contract study coordinators and research support
- Conduct of close-out activities
- IND and IDE applications - preparation and submission
- Annual reporting as required by the FDA, IRB and DSMB
- Informed consent development and submission
- IRB submissions
- Maintenance of regulatory files and subject records
- Audit preparation
- Study monitoring
- AE and SAE reporting
- Coordination of long-term document storage
- Multi-site sIRB
- Trial master file management
- Project management
- Data management
- Data safety monitoring board - development, organization, facilitation reports
- CRF survey development
- RedCap database development
- Access to large, diverse pediatric and adult populations throughout the region, including Southwest Ohio, Southeast Indiana and Northern Kentucky
- Guidance and consultation for consistent and effective participant recruitment and retention practices – children and adults
- Development of strategic study recruitment and retention plans
- Construction of recruitment and retention budgets including advertising
- Creation of all print, electronic and ancillary materials including advertising and social media
- Access to the Clinical Research Services clinical research trial participant database – healthy children and adults
- Access to Cincinnati Children’s clinical trials web pages, 80-plus recruitment flyer boards throughout Greater Cincinnati
- Collaboration with Cincinnati Children’s Data Management Center for single- and multi-site trials
- Data safety monitoring board - development, organization, facilitation reports
- CRF survey development
- RedCap database development
- Investigator-initiated and industry-sponsored trials
- NIH collaborative/consortium group trials
- Rescue/rejuvenation of ongoing trials
- Center for Technology Commercialization
- Biobank
- Division of Clinical Pharmacology
- Data Management Center
- Schubert Research Clinic
- Center for Clinical and Translational Science and Training (CCTST)
- Translational Trial Development and Support Lab (TTDSL)
- Office of Research Compliance and Regulatory Affairs (ORCRA)
- Medical writing
- Abstracts
- Publication rights and agreements
Accreditation
Association for the Accreditation of Human Research Protection Programs
CAP
College of American Pathologists
CLIA
Clinical Laboratory Improvement Act/Amendment
Magnet
American Nurses Credentialing Center
Interested in Clinical Research Services for Your Next Study?
Investigators: Learn more by downloading our Services Brochure.
3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
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