Regulatory Knowledge & 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.
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.
We are pleased to announce our new affiliation with the Western Institutional Review Board (WIRB). Through this collaboration, CTSC Investigators will be able to streamline study start up activities for new clinical trials through the Clinical Research and Regulatory Support Units as 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 which has maintained full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) since 2003. It includes six committees of dedicated, specific professionals to review and provide guidance for new and ongoing research studies. Each committee meets twice a week, guaranteeing prompt attention to each study submission, however, not compromising on a high quality, thorough review.
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 Gwendolyn Azar.
Federal Regulatory Support
Federal Regulatory Support serves as a centralized resource and provides assistance in: Education and training with sponsor-investigator IND or IDE applications. This includes personal consultation and helpful templates through online modules on a range of topics related to FDA regulated studies.
Research Initiation Start-Up Evaluation (RISE)
R.I.S.E. is a program with tools to assist investigators in developing Good Clinical Practice. The program is ideal for NEW clinical research investigators, as well as seasoned clinical research investigators who are interested in improving their knowledge on this topic. The program will introduce investigators to tools that will assist them in the design, conduct, performance, recording, analyses & reporting of their clinical trials/ research projects.