The Clinical Research Facility at the Oral Health Research Institute traces its beginnings back more than four decades. The main purpose of the Facility is to provide the infrastructure to conduct high quality clinical research that is in compliance with GCP/ICH regulations and guidelines. This includes assisting our researchers in all aspects of study management and conduct such as:
Project Development (Pre-Award):
- Participating on study design
- Drafting and/or editing grant-related documents
- Reviewing of clinical procedures, logistics, timeline and resources involved
- Liaising with IU institutes, offices and departments, including the Office of Research Administration (ORA), Office of Clinical Research (OCR), CTSI, OnCore, Biostatistics and Health Data Science, and Investigational Drug Services (IDS)
- Reviewing/referring potential HIPAA and data sharing issues
- Creating study budget and budget justification
- Organizing study-site qualification visit
Project Management (Post-Award):
- Assigning a Study Coordinator/Project Manager
- Assisting in the identification/hiring and training of study personnel
- Create, Review, and Finalize study documents (MOP, CRF, Consenting, Investigator Notebook, etc.)
- Performing/supporting IRB submissions
- Organizing and implementing site initiation meetings
- Recruiting participants
- Screening and enrolling participants
- Conducting study visits
- Monitoring recruitment, retention and compliance according to the study protocol
- Monitoring data quality and compliance with GCP
- Performing study closeout activities
- Assisting with study budget/account management