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:

• Melody J. Sacatos, CIP
  Manager of Protocol Development
  melody.sacatos@yale.edu