Protocol Development and Regulatory Knowledge Support Services

Regulatory Support

• Overall assistance and coordination in translating a research concept or idea into a complete research protocol with all required accompanying documents
• Initial Determination of Exempt or  Not Subject To Human Subjects Protection Common Rule and/or preparation of formal exemption request to applicable Yale IRB
• Development or editing of Yale University  and Veterans Administration, West Haven, IRB application/protocols; including human subjects protection and ethical provisions, data and safety monitoring plan, schematic diagrams of study design, procedures, data collection and management, etc. (Note: Contact Biostatistical Support Unit for issues relative to scientific design and other biostatistical issues such as appropriate schemes for randomization, etc.); Also includes insuring consistency among study documents such as applications, consent documents, sponsor protocol, investigator’s brochure, etc.
• Author or edit consent documentation (consent, assent, permission)
• Assistance in preparing Research Authorization Forms and waivers of authorization
• Assistance in navigating through multiple internal and external scientific and regulatory review and approval authorities; includes protocol specific delineation of pathway through all necessary submittals, coordination, and pre-activation activities
• Coordinate and assist in the development of multi-site protocol management and operational programs plans and procedures, including interfacing with internal and external organizations, Industry, and federal agencies
• Guidance on specific federal requirements such as NIH standards and policies regarding inclusion of children, women, and minorities, and data and safety monitoring
• Initial identification of proposed research that may require an IND or IDE and assistance in preparing regulatory documents in support of such applications; includes specialized submissions such as combination product requests for determination of regulatory jurisdiction
• Specialized assistance for investigator-sponsors for meeting regulatory requirements as a sponsor and investigator
• Quality and compliance review of proposed research documents (application, protocol, consent document, etc.), to ensure compliance and use of best practices, as appropriate,  relative to Yale University, Federal, Sponsor, and other regulatory, guidance, and policy requirements, including as applicable, the HIPAA Privacy Rule, Yale University’s Federal Wide Assurance, and Good Clinical Practice (GCP) 
• Assistance for registration in clinicaltrials.gov as required by federal legislation and in accordance with the policy of the International Committee of Medical Journal Editors (ICMJE)