Clinical Trials
The clinical research support team of the Pediatrics Research Administration Office provides support with all phases of a clinical trial lifecycle, from preparation to award close out, working closely with Columbia’s Clinical Trials Office and the Institutional Review Board. We support faculty with administrative, IRB/regulatory, and clinical coordination aspects of a clinical trial.
Administrative Assistance
- Negotiation and execution of Confidentiality Disclosure Agreements (CDAs). Please note that CDAs cannot be signed by Principal Investigators.
- Submission of all documentation to the Clinical Trials Office (CTO).
- Preparation and negotiation of study budget. (Please note that cost estimates need to be submitted for the budget to be drafted and negotiated with the sponsor.)
- Negotiation and execution of Clinical Trial Agreements (CTAs). Please note that CTAs cannot be fully executed without IRB approval.
- Training for Clinical Research Coordinators (CRCs) and Research Nurses (RNs) to use StudyManager (CTO’s invoicing and payment tracking system).
- Monitoring of CTO dashboards and support with updating StudyManager.
IRB/Regulatory Assistance
- Completion of feasibility questionnaires
- Preparation for pre-study visits
- IRB approval and preparation of regulatory documents
- Consent form development
- Preparation of subject recruitment materials
- Preparation of study documents (e.g. source documents, participant visit packets, dosing cards, etc.)
Clinical Coordination
- Subject prescreening and subject recruitment
- Obtaining informed consent
- Data collection
- Case report form (CRF) completion
- Data entry
- Specimen draw and processing
- Overall maintenance of new and ongoing clinical trials.