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Investigator-initiated studies are managed by the same regulations that apply to the sponsor initiated studies. As an investigator, regardless of the study type, whether it is a chart review or a formal clinical trial, you will be responsible for the proper and safe conduct of your study from initiation until the completion of the study project. It is your sole responsibility to ensure compliance with the federal and state laws, codes of ethics and good clinical practices.
The OCR provides research support to the investigator to facilitate the overall process of a clinical research study. We recommend you follow these steps in order to facilitate the submission and approval process.
Research Question: Is Drug A better than Drug B?
Basic Hypothesis: We hypothesize that Drug A is better than Drug B
Improved Hypothesis: In pediatric populations aged 10-17 years, we hypothesize that Drug A will extend the remission period by at least an additional 5 years over that experienced by patients utilizing Drug B.
Notes: Be sure to address the specific population (pediatric population aged 10-17), quantify the outcome variable (remission period) and be precise about what you are testing (increased remission period that’s at least 5 years longer).
The goal of the literature review is to determine what research has been conducted on your topic of interest and how has it been conducted. This information is necessary because:
Discuss your research question with knowledgeable peers, department chair, mentor, and the biostatistician.
Consider the steps necessary to conduct your study for example, type and phase of the clinical trial, budget, informed consent, sites, resource constraints of both personnel and facilities, study duration.
Draft a Final Protocol for departmental ethical and scientific review. Review should be done in the following order
While drafting a protocol follow the Guidelines for Designing a Clinical Study Protocol.
It may be helpful to use a template when writing your protocol. Click here for a Chart Review protocol template. Click here for a Clinical Trial protocol template.
IRB application and your USF Division of Sponsored Research (DSR) submission can be done simultaneously in order to expedite the process. The DSR submission consists of the Internal Form with the following support documents attached electronically via the File Attachments functionality built into the web-based Research Online Internal Form system:
The Internal Form must be fully executed at the time of proposal submission to the sponsor. Contact your DSR Sponsored Research Administrator for assistance.
The USF IRB application is found at this website: USF eIRB Sign On
Investigator initiated studies are not eligible for WIRB submission for USF investigators. Once the IRB Approval letter is received, forward a copy to your DSR Sponsored Research Administrator for their files.
Start the study.