Additional Information

For any questions related to budgets and contracts, please reach out to a member of our study team for further information and resources.

Any software that is used for research must be reviewed by MUSC’s IT/IS department. There are currently significant delays with this process. If you have any study that involves the use of software or may require IT/IS review, please reach out to the study team as soon as possible to discuss timeframe and processes.

Studies that deal with the use of radiation are subject to review by MUSC’s radiation safety committee. Studies that are deemed appropriate for review by the radiation safety committee will automatically be referred to them by the IRB. A member of the team will reach out to discuss any study specific questions or concerns. Please reach out to a member of the research team with any questions.

Investigational drug services is a pharmacy at MUSC that specializes in the storage and dispensing of research medications. They can be utilized for research projects within the department. They do charge fees based on the type of medication and complexity of the study, so please reach out to a research team member to price out the fees and budget for the study appropriately.

MUSC has the Nexus lab, which is located on the 2^nd floor of the Clinical Sciences Building. They can be utilized for a number of research needs. The Nexus lab can be utilized to process, store, and ship lab samples used for research. Nexus also offers nursing services to assist with research projects, as well as other resources. If you would like to inquire about utilizing Nexus or if you would like to learn more about services offered, please reach out to a member of the research team.

The department does employ a statistician to assist with research studies. In order to utilize these services, they must be approved by the research team prior to study approval. Investigators will meet with the research team and statistician to determine an estimate on time to complete data analysis. This will be accounted for on the budget for any funded studies. For non-funded studies, the department will review time needed and make a decision on a case-by-case basis. Please note there are other options for biostatistical services, such as those offered by the South Carolina Clinical & Translational Institute (SCTR). Please reach out to the research team for more information.

If your study involves cancer or cancer patients, your study will need to be approved by the Hollings cancer center protocol review committee (PRC). This process should be initiated as soon as possible to avoid any delays with the study process. Prior to being assigned to a PRC meeting for review and approval, the study must first be pre-approved by a Hollings Cancer Center disease focus group (DFG).

In accordance with the HCC Protocol Review and Monitoring System, all cancer-related hypothesis-driven clinical research studies conducted at MUSC must first be reviewed by the respective Disease Focus Group for an initial assessment of value, fit, and prioritization within the existing trial portfolio.

DFGs:

• Phase I unit
• Breast
• Gastrointestinal
• Genitourinary
• Gynecological
• Head and neck
• Hematological malignancies
• Melanoma
• Neurological
• Pediatric
• Sarcoma
• Thoracic

Studies will then be reviewed by the HCC Protocol Review Committee (PRC) for scientific merit.

This may include studies that target cancer patients or studies enrolling non-cancer patients that include cancer-related objectives (e.g., cancer control trials, cancer diagnostic trials, epidemiological and behavioral studies and health services research).

Per the MUSC Institutional Review Board (IRB), any cancer-related trials will automatically be routed to the PRC. For any institutional trial that is subject to PRC review, approval must be obtained prior to IRB review. All other studies that are not institutional trials may undergo PRC and IRB review simultaneously. HCC PRC approval must be obtained and submitted in eIRB before IRB approval is released.

Protocol Review Committee - New Form (musc.edu)