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Regulatory Knowledge & Support (RKS)

The Regulatory Knowledge and Support (RKS) team at the SUCCESS Center is happy to assist investigators and study teams with a variety of regulatory needs. To request regulatory assistance of any kind we ask you to please submit a SPARCRequest. Instructions and screen shots are included below. Services offered through our RKS group that can be requested in SPARCRequest include the following:

  • Human Subjects Regulatory Consultation: Provide assistance with any part of the Human Subjects research process such as eIRB submissions, document development, FDA or IBC submissions, study documentation, or GCP. *Please note, mentors must participate in regulatory consultations requested by their students.
  • Protocol Writing Assistance: Provide assistance with the development of a research plan focusing on the development of quality study objectives and methods. Priority will be given to faculty and fellows. Trainees will be expected to include their mentors in the consultation process.
  • Basic Science/Animal Regulatory Consultation: Provide assistance with regulatory aspects of the Translational research process including IACUC or IBC submission consultation.
  • Clinicaltrials.gov Consultation: Provide assistance with study registry, results reporting, or determining registry requirements for a particular study.

If you have basic eIRB system troubleshooting questions, please refer to the eIRB Consolidated User Guide and other system materials on the MUSC eIRB page. Once you have reviewed the materials, if you are still having trouble, please feel free to submit a request for a “Human Subjects Regulatory Consultation” through the SPARCRequest system.

Instructions for Submitting a SPARCRequest

To schedule a free consult we ask that you submit a request in SPARCRequest. If the study already exists in SPARCRequest you will want to go to your SPARCRequest dashboard, select the study, click “modify request” and add the service indicated. If the study does not already exist in SPARC, you will start at the SPARC catalog page. Once you have added the service and hit “Continue” you will be prompted to enter your username and password (which is just your NetID and password). You will then be asked if this request is for a “new research study or project”. You will select “yes,” indicating that this study does not currently exist in SPARCRequest and you will then be prompted to create the study by completing the required fields, hitting “Save and continue” as you move through a series of steps. Once all of the steps have been completed and you have “Submitted” the service request, you will be contacted by a member of our regulatory core within one business day to schedule your consultation. Please feel free to contact the SUCCESS Center at 843-792-8300 if you have trouble navigating the system.

Screenshot showing how to submit a SPARCRequest

Contact

Leslie Bell

Leslie Bell

Regulatory Lead
843-792-0451 bella@musc.edu

Toni Mauney

Toni Mauney

Regulatory Coordinator
843-792-2449 allet@musc.edu