Welcome to Novant Health Heart and Vascular Institute's division of research, where patients are our primary focus.
The Novant Health Heart and Vascular Institute research group will only participate in clinical protocols that meet our standards for ethics, safety and scientific relevance, ultimately improving our ability to care for our patients.
CVI Research Services:
- Review clinical study information submissions and match sponsors with investigators
- Provide experienced coordinators
- Scientific and medical consulting
- Complete IRB and regulatory submissions
- Negotiate contracts and budgets
- Provide training for investigators and coordinators
- Manage financial aspects such as accounts payable and accounts receivable
- Ensure compliance with FDA and ICH guidelines
Our collaborative model allows us to:
- Share cardiovascular research studies across all providers
- Market services to attract new research opportunities
- Provide access to a large database of patients
- Share business strategies and ideas
- Ensure that each practice can maintain their autonomy and flexibility
Resources & Tools
Agencies
Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)
International Conference on Harmonisation
Office for Human Research Protections (OHRP)
Other Information
Department of Health and Human Services (HHS) Protection of Human Subjects Regulations 45 CFR 46
FDA Information Sheets
Belmont Report
Declaration of Helsinki
Nuremberg Code
Electronic Records 21 CFR 11 - FDA regulations on the use of electronic records and electronic signatures in the FDA approval process.
Training Resources
NIH Required Education in the Protection of Human Research Participants
CITI Training Program