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.

Resources