Regulatory Knowledge and Support

The mission of the CTSC Regulatory Support Unit is to support the investigator community in developing regulatory and clinical strategies and fulfilling regulatory requirements for clinical research programs along the continuum of clinical, translational, and community research.

The Regulatory Knowledge & Support Unit supports this mission through a centralized service portal within the CTSC and through collaboration with the UNM HSC Human Research Protections Office (HRPO), and can assist the investigator and research team in all stages of research from conceptualization to implementation of a clinical research endeavor.

Research Participant Advocacy

The Research Participant Advocate (RPA) helps to ensure the safety of research participants who enroll in studies conducted through the Clinical and Translational Sciences Center. The RPA works closely with the Human Research Protections Office (HRPO) to promote and facilitate safe and ethical conduct of human research and to provide consultation to research teams.

Research Submission Support (ClickIRB)

CTSC Regulatory Support service is available to prepare initial submission of your IRB application for the new studies to the local IRB.  Investigators that are interested for the use of this service, please complete the Request for Resources Form and submit to the CTSC Research Concierge.

WIRB Partnership

Through collaboration with the Western Institutional Review Board (WIRB), CTSC Investigators will be able to streamline study start up activities for new clinical trials through the Clinical Research and Regulatory Support Services well as initiate studies in a prompt and efficient manner.

To qualify for this service, you must:

  • Obtain Departmental Review and Approval
  • Provide a fully industry sponsored Phase II, III, or IV clinical trial
  • Utilize our CTSC Regulatory Support Service in addition to other CTSC Resources

WIRB is an independent IRB that has maintained full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) since 2003. If you are interested in exploring the possibility of using WIRB in conjunction with our Regulatory Management and/or Study Coordinator services, please complete the Request for Resources Form and submit to CTSC Research Concierge.

Additional Regulatory Support Resources

Clinical Trials Requirements

Regulatory Submission Templates