Support Services and Resources
• Development of investigator-initiated research grants and protocols
• Recruitment of industry-sponsored clinical research trials/protocols
• Protocol development consultation for industry-sponsored studies
• Protocol feasibility assessment/design
• Protocol review and approval process
• Faculty investigator identification for industry-sponsored clinical studies or multi-center studies, irrespective of funding source
• Scheduling and coordination of sponsor site assessment visits at Cincinnati Children’s
• Industry sponsor identification for investigator-initiated clinical trials
• Recruitment of industry-sponsored clinical research trials/protocols
• Protocol development consultation for industry-sponsored studies
• Protocol feasibility assessment/design
• Protocol review and approval process
• Faculty investigator identification for industry-sponsored clinical studies or multi-center studies, irrespective of funding source
• Scheduling and coordination of sponsor site assessment visits at Cincinnati Children’s
• Industry sponsor identification for investigator-initiated clinical trials
• 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
• 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
• Execution of CDAs
• CTA facilitation as required by Cincinnati Children’s Research Foundation administration
• Budget consultation, development, review, analysis and sponsor negotiation
• Institutional budgetary approval
• Financial reports and statements
• Facilitation of the contract process
• Issue, review and negotiation of NIH and foundation funded clinical trial agreements
• CTA facilitation as required by Cincinnati Children’s Research Foundation administration
• Budget consultation, development, review, analysis and sponsor negotiation
• Institutional budgetary approval
• Financial reports and statements
• Facilitation of the contract process
• Issue, review and negotiation of NIH and foundation funded clinical trial agreements
• IND and IDE applications - preparation and submission
• Annual reporting as required by the FDA, IRB and DSMB
• FDA interactions and communications
• 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
• Annual reporting as required by the FDA, IRB and DSMB
• FDA interactions and communications
• 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
• 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 OCTR clinical research trial participant database – healthy children and adults
• Access to Cincinnati Children’s clinical trials web pages, 60-plus recruitment flyer boards throughout Greater Cincinnati, as well as the semiannual booklet of “Research Studies at Cincinnati Children’s”
• 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 OCTR clinical research trial participant database – healthy children and adults
• Access to Cincinnati Children’s clinical trials web pages, 60-plus recruitment flyer boards throughout Greater Cincinnati, as well as the semiannual booklet of “Research Studies at Cincinnati Children’s”
• Collaboration with Cincinnati Children’s Data Management Center for single- and multi-site trials
• Investigator-initiated and industry-sponsored trials
• NIH collaborative/consortium group trials
• Rescue/rejuvenation of ongoing trials
• NIH collaborative/consortium group trials
• Rescue/rejuvenation of ongoing trials
• Center for Technology Commercialization
• Biobank
• Division of Clinical Pharmacology
• Data Management Center
• Data Coordinating Center
• Clinical Translational Research Center (CTRC)
• 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
• Abstracts
• Publication rights and agreements
Accreditation
Interested in OCTR Services for Your Next Study?
Investigators: Learn more by downloading Cincinnati Children’s OCTR Services Brochure.
Contact Us
Office for Clinical and Translational Research (OCTR)
Office phone: 513-636-3232
Fax: 513-636-0168
OCTR@cchmc.org
Office phone: 513-636-3232
Fax: 513-636-0168
OCTR@cchmc.org
3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
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