FAQs here are related to the SOM CRSO initiative and not specific to COVID-19 response or operations.

1. Why are you creating the SOM CRSO?

The CRSO is being developed in order to advance the research mission of the SOM by reducing administrative burden, enhancing research compliance, and enabling greater efficiency, collaboration, financial productivity, and growth of our clinical research portfolio.

2. Will having another research administrative office slow down existing research processes?

The CRSO will work to identify and overcome administrative obstacles that currently exist, as well to streamline processes and operationalize strategic solutions such that research projects can be initiated and executed more efficiently.

3. Will the CRSO require me to change my current operational methods?

The CRSO will establish some standards and guidelines that are needed to harmonize research practices across the SOM to improve efficiency and compliance, as well as to enable improved tracking and reporting. The CRSO will not aim to disrupt workflows or processes that meet these needs, that are specific to unique therapeutic areas or interventions, or that would in any way hinder research productivity.

4. I have some research projects that are not really “clinical,” but do involve human subjects. Will the CRSO support that portfolio of projects as well?

Yes, the scope of the CRSO will include all human subjects research studies conducted within the School of Medicine.

5. Can the CRSO manage my entire research project for me?

The CRSO will not serve as a research project management office or data coordinating center. But the office will help investigators identify appropriate resources to directly support their research needs. Those resources may be within the PI’s own department, within other research support offices, such as NC TraCS, or potential external resources we can help to make available.

6. What are the potential benefits of having the CRSO for a seasoned investigator? What about a junior investigator? What about research staff?

The CRSO will serve as a “one-stop shop” for all SOM research personnel to help navigate all aspects of clinical research at UNC. The CRSO will promote transparency in research operations and empower teams to effectively evaluate their own research portfolios. The CRSO will be responsive to the evolving needs of the clinical research community within the SOM, continually working to identify and overcome obstacles. The CRSO will standardize research processes to promote consistency and compliance, as well as develop and disseminate tools and resources to bolster effective research practices. The CRSO will also support development, training, and retention of the clinical research workforce. In short, the CRSO aims to help all research personnel to achieve their research goals more efficiently.

7. My team really needs more clear and routine training opportunities. Will the CRSO help with that?

Yes, the CRSO will work with UNC research administrative offices, SOM subject matter experts, and additional professional resources to offer competency-focused training and development opportunities to empower clinical research personnel.

8. Can the CRSO offer administrative financial management of my contracts and grants?

The CRSO will not directly administer financial management of research accounts, but the office will establish and disseminate standardized processes and tools, accompanied by training and direct support, to bolster research teams’ financial management of clinical research projects.

9. How does the CRSO relate to other administrative research offices at UNC?

The CRSO will not replace or duplicate efforts of any existing research offices. The CRSO will collaborate with existing offices to define standardized processes and establish clear guidelines to support SOM research personnel in clinical research activities. For example, the CRSO cannot provide an IRB approval or serve as a review board, but will provide resources, training, and tools to promote efficiency and best practices among study teams developing and submitting IRB applications.

 

If you have additional questions you would like to see added to the FAQ list, please contact us by email at crso@med.unc.edu.