Research Services
The Office of Clinical Research (OCR)
St. Joseph Medical Center
St. Clare Building, Second Floor
7601 Osler Drive
Baltimore, MD 21204-7582
E-mail address: ocr@catholichealth.net
Director: Carol Natale, 410.427.2031
The OCR is liaison among investigators, St. Joseph Medical Center administration and study sponsors. It is the primary office responsible for the regulatory and finacial aspects of clinical research, and advocates for the process of research at St. Joseph. Its staff provides for the facilitation of safe and ethical clinical research projects from initiation through close out, including but not limited to:
- Oversight of St. Joseph compliance with federal laws and regulations and any related Institutional policies for human research subjects' protection
- Assessment of study procedures and study visits to develop study budgets
- Contract review and negotiation
- Protocol review by Scientific Review Committee (SRC) for scientific, ethical and operational impact of a study on St. Joseph
- IRB regulatory oversight through the Western Institutional Review Board (WIRB)
- Assure that informed consent process is provided to research participants
- Monitor human subjects training requirements
- Ensure billing compliance for clinical trials
- Conduct compliance audits of clinical trials
- Maintain applicable research records
St. Joseph Medical Center and the Western Institutional Board are designated under the Institution’s Assurance and agree to comply with the Federal Policy for the Protection of Human Subjects (http://www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm) when engaged in federally-conducted or -supported human subjects’ research to which the FWA applies, as well as with any clinical research conducted at or by St. Joseph employees or agents.
The St. Joseph Medical Center’s Federal Wide Assurance number is: FWA00002226
When a St. Joseph research investigator participates in a cooperative research project, the protocol must be reviewed and approved by the Western Institutional Review Board for St. Joseph as well as the IRB designated by each participating investigator or research site.
Please let us know how we can assist you in identifying, initiating and completing your clinical research studies at St. Joseph Medical Center.
