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

• Study Specific Audits: Post-approval study review designed to support research compliance through assessment and education. Studies are randomly selected for routine reviews.
• Programmatic Audits: Designed to evaluate processes in place across research at the organization by looking at a larger sample of studies but with a specific focus area, including:
  • Alternative Forms of Consent 
  • ClinicalTrials.gov
  • Clinical Trial Billing Reviews
  • Conflict of Interest
  • Investigational Pharmacy Reviews
  • Material Transfer Agreements
  • Non-English Speaking Participants

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, clarify study procedures, study start-up materials, review roles and responsibilities of each staff member, identify regulations and policies pertinent to the study, as well as provide material and tools to facilitate adherence for each new study (e.g. source document templates).
• Research Education Series: A collaboration between Corporate Compliance and the Human Research Protection Program (HRPP) to bring practical education and disseminate process updates. The series generally runs on a monthly basis covering topics relevant to the research community.

Tools & Helpful Resources