Researchers & Coordinators

The St. Vincent Investigator Manual defines the educational requirements for the conduct of human subject research as follows:

• Investigators and staff conducting human subject research must complete either the online Collaborative Institutional Training Initiative (CITI) human subjects online training program.
• The CITI site can be accessed at www.citiprogram.org
• Training is valid for a three-year period, after which time the training must be repeated.

The St. Vincent IRB will not approve a request for a new or continuing research study until all members of the Research Team have met the education requirements.

All Research Team members (individuals who conduct research involving human subjects, or who assist in the performance of such research activities) where that research will be performed at or under the auspices of any St.Vincent system hospital or subsidiary ministry (Ministry) must complete this training.  The term "research involving human subjects" includes any research-related procedure conducted at the Ministry or any Ministry-controlled facility.

For the purposes of the educational requirement, a human subject means a living individual about whom a person conducting research obtains 1) data through intervention or interaction with that individual; or, 2) information that is both private and identifiable.

CITI is a web-based human research protections training program created by the Collaborative Institutional Training Initiative. Individuals affiliated with St.Vincent can access the CITI program at www.citiprogram.org

Existing CITI Users: Use your CITI username and password to access the system. 

NOTE: If you have already registered with CITI, even if that registration was with an organization other than St.Vincent, you do not need to re-register.  Just use the username and password you had from your prior registration to access the system.  Once you have logged onto the CITI system, you will have the option of changing your institutional affiliation.  To do so, click the option for "Affiliate with another institution", and choose Ascension as your Participating Institution.

New CITI Users: At the main CITI login page, click the New Users "Register Here," and choose Ascension as your Participating Institution.  Complete the remainder of the registration steps as instructed on the CITI page, and click the "Submit" button.  NOTE:  CME/CEU credits can be obtained for your CITI coursework, but St.Vincent does not currently provide the funding for obtaining these credits

Yes. All students, residents, and fellows who are investigators, co-investigators, or members of a Research Team must complete the mandatory education.

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.

We assist with study budget development and coverage analysis/billing grid preparation.

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  Office of Research and Clinical Trials using the Clinical Study Intake Form, and our staff will facilitate the processing of these agreements through the St. Vincent Contract Management system.

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.

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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