The CRSC must approve all research projects being conducted at Seton facilities prior to initiation of the study. This is in addition to IRB approval. The role of the CRSC is to ensure alignment of research projects with the mission and resources of the institution. Approval by the CRSC does not constitute IRB approval. Therefore, approval by both entities is necessary before any study can begin. The CRSC submission process can begin in parallel when submitting to the Seton IRB. If using external IRB – as permitted by Seton – please submit to CRSC AFTER obtaining IRB approval.
The CRSC is responsible for reviewing the clinical, administrative, financial, operational, and ethical issues related to a research study. This includes – but is not limited to – the following, as applicable:
- Centers for Medicare and Medicaid Services (CMS) Approval
- Product Approval Team (PAT) Approval
- Impact on non-research staff and/or departments (Study Feasibility)
- Data transmission, collection, & use
- IS security – data transmission & software/hardware implementation
Preparation for CRSC submission should begin once the researcher has identified/developed a study protocol. For more information about CRSC preparation, please see the budget development/study feasibility and contracting process. Once the study budget and study feasibility have been completed, please review and complete the Clinical Research Steering Committee Submission Form. Please note that your submission will not be processed for review until all required documents have been submitted and the form is completely filled out. If you have any questions about the CRSC submission and review process, please call 512-324-7991, option 2.
Budget Development/Study Feasibility
Any study that involves research specific procedures or impacts individuals or departments separate from the researcher will need to be reviewed for cost and operational impact on Seton. It is important to do this well in advance of submission to the CRSC as your submission will not be considered viable until the budget has been finalized and study feasibility has been completed. To initiate this process, please contact our clinical trials specialist at 512-324-7991, option 3.
The following list includes examples of studies that will require a contract:
- Non-Seton employed Investigators or Study Team Personnel
- Data Sharing
- Intellectual Property
- Investigational Drugs or Devices
- Funded Studies or Studies with a Budget
- Studies where Seton is a participating site with an outside institution
To determine if your study will require a contact and to facilitate the process, please contact our Contracts Manager at 512-324-7991, option 4.
Direct Contact Information:
Estrellita Doolin – Research Contracts Manager
e-mail: firstname.lastname@example.org; Phone: 512-324-7000 ext. 77305
Myriam S. Windham – Clinical Trials Specialist
e-mail: msWindham@seton.org; Phone: 324-7000 ext. 77330
Rena Summers – Clinical Research Manager
e-mail: rlSummers@seton.org; Phone: 324-7000 ext. 88310
|CRSC Submission Form||Download Word doc|
|CRCS FAQ||Download Word doc|
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|Lab Attachment||Download Word doc|
Patient Load Form
|Pharmacy Attachment||Download Word doc|
Study Feasibility Template