Clinical Management & Research Support
- Assistance with protocol writing
- Protocol review and approval process
- IRB submission
- Informed consent
- Investigator and site initiation meetings
- Development of case report forms
- Pre-printed study orders
- Investigational New Drug (IND) application
- Study closure
- Eligibility
- Subject recruitment
- Registration
- Required observations
- Data management and submission
- Patient brochures and educational materials
- Coordination of protocol visits
- Adverse events reporting
- Specimen collecting and handing
- Clinical management and support of the subject
- Protocol amendments and continuing reviews
- Regulatory files and subject records
- Interactions with the IRB
- Site/Sponsor/Research Office communications
- Quality assurance/audits/monitor visits
- Data Safety Monitoring Board
- Adverse Event and Serious Adverse Event reporting (IRB, FDA, AdEERS)
- Secretarial support
- Supplies, equipment
- Database support
Contact Us
For more information, contact:
Lori Backus, BA, CCRP
Oncology Clinical Research Manager
513-636-2047
lori.backus@cchmc.org
Teresa Latham, MA, PCC-S
Director of Operations, Clinical Research
Hematology Clinical Research Manager
513-803-7922
teresa.latham@cchmc.org
Joan Moore, BS, CCRP
Bone Marrow Transplant/Immunology Clinical Research Manager
513-636-8316
joan.moore@cchmc.org
3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
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