Yale School of Medicine

Yale Center for Clinical Investigation

Yale Center for Clinical Investigation

Yale Center for Clinical Investigation
2 Church St. South
New Haven, CT 06519
Tel: 203.785.3482
Fax: 203.737.2480
ycci@yale.edu

Protocol Development and Regulatory Support

The Protocol Development and Regulatory Support unit assists investigators with developing protocols and guides them through IRB review in order to facilitate patient enrollment. The expert support provided by the protocol unit includes assistance in:

  • Translating a research concept into a complete protocol, including schematic diagrams
    of study design, procedures, and data collection and management
  • Development or editing of IRB applications, including consent forms, human subjects
    protection and ethical provisions and data and safety monitoring plans
  • Preparing research authorization forms and waivers of authorization
  • Registration on clinicaltrials.gov as required by federal legislation and in accordance
    with the policy of the International Committee of Medical Journal Editors related to the
    publication of research findings
  • Compliance with federal, state and university regulatory and policy mandates

The staff is available to aid investigators at any stage of a research project’s development, including laying the groundwork for a new proposal; helping with the IRB application for a sponsored protocol; or negotiating informed consent.

To find out how YCCI can provide protocol assistance for your research proposal, please contact Melody Sacatos at 737-4512 or melody.sacatos@yale.edu; or Theresa Katz at 785-6335, or theresa.katz@yale.edu.

Protocol and Regulatory Contact: