The St.Vincent Research and Regulatory Affairs Department serves as a centralized resource for researchers (physician, nurses, residents and others) throughout the St.Vincent Health System. Specific areas of consultation/assistance are:
Research protocol design
Protocol design often is the first step in investigator initiated research and we assist investigators with an idea for a research project by helping develop a research hypothesis, a reliable study design, and an appropriate research protocol.
Expert statistical consultation is available through our office, including protocol development, statistical methodology, and data management and analysis.
Research Budgeting and Billing Compliance
We assist with study budget development and coverage analysis/billing grid preparation.
Institutional Review Board (IRB) Submission
After investigators design their projects, they will need to complete an IRB application to ensure compliance with federal, state, and organizational human subject protection regulations and policies. In addition to the initial application, investigators may need to complete amendments, continuing reviews, and final reports. Our staff is available to provide expert advice prior to IRB submission to ensure the smooth and timely processing through the IRB system.
All legally binding contractual documents for clinical research, including, but not limited to, Confidential Disclosure Agreements (CDA) and Clinical Trial Agreements (CTA) must be reviewed and negotiated through an attorney designated by the St.Vincent Contract Management Office. The purpose of such negotiations is to ensure that study subjects, investigators, and St.Vincent are legally protected. All CDAs and CTAs received from sponsors should be submitted through the Research and Regulatory Affairs Department using the Clinical Study Intake Form, and our staff will facilitate the processing of these agreements through the St.Vincent Contract Management system.
Good Clinical Practice (GCP) & Research Compliance Support
Once the study has begun, our clinical research compliance program is available to help ensure clinical research performance excellence, as well as regulatory compliance. The services offered by the clinical research compliance program include:
- Internal IRB/GCP auditing: During an internal auditing visit, our staff review regulatory documentation and subject files, including consent forms. All internal auditing visits include an exit interview and a written report, both of which address all auditing observations, corrective actions, and quality improvement recommendations.
- Preparation for external audits: Our clinical research compliance staff has the knowledge, expertise, and experience to assist you when you need to prepare for audits by the FDA, NIH, sponsors, or other external agencies. Upon receipt of an audit notification, contact our office to request an on-site review of all study files. This internal pre-audit provides you with the opportunity to identify deficiencies and take necessary corrective actions before an external audit commences.
- GCP toolkit: To assist investigators with study documentation, the clinical research compliance staff can provide logs, templates, and compliance checklists.
Contact us at email@example.com or 317.338.2194 to access any of the services described above.
Other Research Support Services
In addition to the services available within the Research and Regulatory Affairs Department, our staff can also facilitate access to resources in other areas of St.Vincent Health.
Investigational pharmacy service is available to help ensure patient safety through adherence to protocol-specific drug treatment and monitoring parameters. Compliance with regulatory requirements for clinical drug trials is maintained through appropriate data collection and monitoring. An experienced investigational pharmacist provides expertise on drug study set-up and procedures from start-up to completion of the clinical trial.
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