Protocol Development and Regulatory Support

YCCI’s Protocol Development and Regulatory Support unit assists investigators with designing and developing protocols. The unit’s expert staff is available to aid investigators at any stage of a research project’s development, including laying the groundwork for a new proposal. Other services include:

• Registration on clinicaltrials.gov
• Translating a research concept into a complete protocol
  
• Navigating the IRB review process
  
• Development or editing of consent forms, human subjects protection and ethical provisions, and data and safety monitoring plans
  
• Preparing research authorization forms and waivers of authorization
  
• Compliance with federal, state and university regulatory and policy mandates

To request this service, please complete the YCCI Intake Form.

For more information regarding Protocol Development and Regulatory Support, please contact the Office of Research Services at clinicalresearchresources@yale.edu