Information for Investigators

Investigator Information

The Our Lady of the Lake Office of Research provides the following services for investigators engaged in clinical research:

Study identification
Contract and budget negotiation
Financial billing compliance
Preparation and submission of all regulatory documents
Study implementation within the hospital and/or physician practice
Investigator and staff training
Study coordination for all clinical procedures, including patient recruitment and study visits
Data management
Archival of study-related materials after study close out

How to Become an Investigator

Who can be a principal investigator?

Only individuals who are employed by Our Lady of the Lake or who have privileges at Our Lady of the Lake can serve as a principal investigator (PI) on a research study
Medical students, residents, and other trainees are not eligible to act as a PI on a research study; however, these trainees may serve as co-Investigators or other research personnel on a research study

What training is required to be an investigator?

Our Lady of the Lake employees, affiliated/contract employees or trainees, or volunteers:

All investigators and other research personnel must complete Collaborative Institutional Review Board Training Initiative (CITI) training
CITI training is available at www.CITIprogram.org
Our Lady of the Lake employees, affiliated/contract employees or trainees, or volunteers must affiliate with Franciscan Missionaries of Our Lady Health System (FMOLHS). The Office of Research also accepts CITI training from outside organizations when research personnel are students are employees of those organizations
CITI certification is valid for 3 years

Research Approval Process

All studies that involve FMOLHS patients, personnel, or facilities must be reviewed by the OLOL Office of Research before they may begin. Feasibility review should occur prior to IRB submission
Feasibility submissions are completed in IRB Manager (franu.my.irbmanager.com). Click here to submit a new research feasibility application
The following materials must be submitted for feasibility review:

Protocol
Consent (if applicable)
CVs and CITI training for all study personnel and professional licensure (when applicable)

All studies are reviewed for scientific and clinical merit, regulatory compliance, and compliance with ethical and religious directives. Studies may also be reviewed by other impacted departments, including pharmacy and nursing, when applicable
Once a study is approved for feasibility, the researcher will receive an Endorsement Letter from the OLOL Office of Research that should be included in the IRB application

Templates and Forms

Forms:

Templates: