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UNC SRC is a group of clinical and biological researchers from various disciplines including pulmonology, pediatrics, women’s health, genetics/omics, psychiatry and endocrinology. They are selected based on their expertise in designing and executing studies in their areas of practice.

The committee is affiliated with the UNC Office of Clinical trials and the Office of the Vice Chancellor for Research and works closely with the UNC IRB.

The mission of the committee is to improve clinical research at the University of North Carolina at Chapel Hill.


What does the UNC SRC do?

The committee evaluates the scientific merit and integrity of each study.

In order to complete this evaluation, the SRC reviews the master protocol documents (MPD) for studies and considers the alignment between study design, target sample size, specific aims, recruitment method, outcome measures, study procedures, data collection/quality assurance, safety monitoring, and aim-specific statistical analysis plan. The SRC then provides feedback to the study’s key personnel.

These comments are intended to help investigators identify the study’s potential scientific, statistical and logistical issues during the study planning process. The goal is for the SRC’s input to help investigators to create detailed protocols that can serve as a clear reference document once the study is under way.

In addition, the SRC’s input is used during the IRB approval process.


What is the difference between the UNC SRC and the UNC IRB?

The missions of the UNC IRB and UNC SRC complement each other and do intersect at times, but each have very different duties. It’s important to understand the difference between them.

The SRC reviews study protocols and evaluates the scientific merit and importance of the study, study design, feasibility, statistical analysis plan and data management plan. The SRC also makes sure that the study has clearly stated aims and measurable outcomes. In addition, the SRC keeps GCP, FDA and UNC Research regulatory and policy requirements in mind during the protocol evaluation process.

Once the SRC has determined that the protocol is ready to move forward, the investigator submits the approved protocol, along with the SRC’s comments, to the IRB as part of the IRB application packet. Once the IRB application is submitted, the IRB evaluates the study for ethical concerns such as risk/benefit ratio for participants, consideration of participants’ rights and welfare, and ethical conduct of investigators and the study team (i.e. conflict of interest). Like the SRC, the IRB also keeps state, federal and UNC regulations and policies in mind during their evaluation process.

SRC

  • Scientific Merit & Importance
  • Feasibility
  • Clearly Stated Aims
  • Relevant Outcome Measures
  • Appropriate Data Management & Safety Monitoring Plans
  • Statistical Integrity
  • Adherence to GCP, FDA, & UNC Research Requirements

IRB

  • Subjects╩╝ Rights & Welfare
  • Ethical Conduct in Research
  • Appropriate Background & Training of Research Personnel
  • Transparency Regarding Risks and Benefits of Participation
  • Equal Opportunity & Parity
  • Adherence to Federal & State laws, OHRP & UNC Policies


How does SRC review help me as an investigator?

Having a comprehensive protocol with clearly stated outcomes can also help studies stay compliant with NIH ClinicalTrials.gov policies regarding registration and outcome reporting.


When does the SRC meet?

The SRC meets weekly. Protocols submitted via the SRC Portal will be evaluated within two weeks from submission date.