Preparing for a clinical trial

We support faculty with administrative, IRB/regulatory and clinical coordination aspects of a clinical trial:

Administrative

  • 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

IRB/Regulatory:

  • 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
  • CRF completion
  • Data entry
  • Specimen draw/processing

We have a team of Clinical Research Coordinators and Regulator Coordinators to support you with IRB/regulatory and clinical coordination aspects. To request such support, please complete this form and submit it to pedsra@columbia.edu

Resources