Research Compliance Program Connecticut Children’s Research Compliance Program serves all members of the research community including but not limited to the Institutional Review Board (IRB), Office of Grants and Sponsored Research Programs, Clinical Trials Unit, research department, investigators and research staff. The goals of the program include the following: Facilitate a culture of research compliance through continuous quality improvement activities including post-IRB approval study reviews, education and consultation; Assess research compliance with Connecticut Children’s policies and procedures, applicable federal, state and local regulations; and coordinate organizational-wide initiatives to reduce research compliance risks; Support the goals of the Human Research Protection Program (HRPP) to ensure the rights and safety of study subjects; Improve investigator performance by identifying risk areas and assisting investigators and research staff in the implementation of tools and strategies to prevent research compliance issues. Services Reviews Research Compliance & Education Review – Post-approval study review designed to support research compliance through assessment and education. Studies are randomly selected for routine reviews on a monthly basis. Clinical Trial Billing Review – Focused study audits to prevent, address, and correct any billing issues. Education New Investigator or Research Staff Orientation – Provides an overview of the research program, research policies and available resources. One-on-one or Small Group Consultation/Education – Upon request, provides additional training, education, or assistance regarding best practice on various research topics. Study Initiation Visits – Conducts study initiation meetings with investigators and associated research staff to ensure the following: correct understanding of the protocol, study procedures, study start-up materials, and roles and responsibilities of each staff member; identify regulations and policies pertinent to the study; provide material and tools to facilitate adherence for each new study (e.g. source document templates). Research Education Series – A collaboration with Corporate Compliance, the Human Research Protection Program (HRPP), Office of Grants & Sponsored Programs, Clinical Trials Unit, and Department of Research to provide monthly presentations (internal-only link; must be connected to Connecticut Children’s network to view) on topics relevant to the research community. Have ideas or suggestions on topics you would like to see? Contact Julie Holub, Research Compliance Manager, via email or at 860-837-6273. Transportation of Biological Specimens for Research Studies – Are you transporting biological specimens for your research study? Here’s what you need to know: Mandatory training in Cornerstone is required prior to transporting specimens. To complete the training, simply log into Cornerstone, type “biological” in the search field, and “launch” the training module. Be sure to print your Certificate of Completion and file it in your study regulatory binder. Use the Biological Specimen Chain of Custody Form for Connecticut Children’s Research Studies to document the transportation of specimens including quantity and description of specimens, study information, and contact information for both transporting and receiving parties. Questions? Please email Julie Holub, Research Compliance Manager. Tools & Helpful Resources Regulatory/Source Doc Templates Consent & HIPAA Tracking Log Consent Form Discussion (Non-Treatment Study) Demographics Eligibility Criteria Note-to-File Research Staff Delegation & Training Log Study Progress Note Subject Screening & Enrollment Log Subject Compensation (Cash) Receipt Subject Compensation (Gift Card) Receipt Subject Compensation Log Self-Monitoring Tools Clinical Research Study Self-Monitoring Tool (Non-Drug Study) Have a question? Please contact the Research Compliance Manager at 860.837.5994 or via email.