Clinical Operations supports human subjects research, providing resources to support clinical (human and veterinary), translational, and One Medicine research.
The Clinical and Translational Regulatory Support office assists clinical (human, veterinary, and translational) researchers who are engaged in studies that will be part of a clinical development program.
The OVPR Quality Assurance office (QA) supports and ensures established quality standards in science are met, particularly for research and manufacturing activities that are regulated by federal law.
The Translational Informatics Support office provides tools to assist in managing data for studies involving human subjects research, veterinary clinical research, and Good Practices (GxP) research, and tools for managing biobank repositories.
Clinical Operations Support
Clinical Operations supports human subjects research, providing resources to support clinical (human and veterinary), translational, and One Medicine research. The office promotes consistency with national standards and best practices.
Services include:
- Advice and guidance on study and protocol development.
- Assistance with management of external contract research organizations (CROs)
- The CSU veterinary Clinical Review Board (CRB), in collaboration with the Institutional Animal Care and Use Committee (IACUC), conducts the review and approval process for projects that involve the use of client-owned animals in research, teaching, and testing. The CRB supports quality and ethical conduct of research through the peer review process and educational opportunities.
- Support for ClinicalTrials.gov registration – request registration for a clinical trial
- Note: If an outside party is responsible for registering and maintaining the study record with ClinicalTrials.gov, it is the responsibility of CSU Principal Investigators (CSU PI’s) to maintain a record of the ClinicalTrials.gov registration NCT number.
- For information regarding who is responsible for registering and reporting results, and which studies require ClinicalTrials.gov registration, visit ClinicalTrials.gov. Clinical trials that are required to be registered with ClinicalTrials.gov with timely reporting of results include:
- Applicable clinical trials (ACTs) are required by law to be registered with ClinicalTrials.gov – visit ClinicalTrials.gov’s Checklist and Elaboration for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT).
- Clinical trials funded by NIH are required to be registered with ClinicalTrials.gov – visit the decision tool on the NIH Grants & Funding website containing the NIH definition of a clinical trial that must be registered with ClinicalTrials.gov
- Clinical trials for which trial information will be published in an ICMJE journal.
- for general questions about Clincial Operations
- support services for study participant payment
- for support services for study participant payment
- to learn additional information about ClinicalTrials.gov registration
Email Dr. Tracy Webb or Dawn Duval about
- CSU veterinary Clinical Review Board (CRB)
Quality Assurance Support and Good Practices (GxP)
The OVPR Quality Assurance office (QA) supports and ensures established quality standards in science are met, particularly for research and manufacturing activities that are regulated by federal law. QA engages with teams across CSU that follow Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and Good Clinical Practice (GCP).
Clinical and Translational Regulatory Support
The Clinical and Translational Regulatory Support office assists clinical (human, veterinary, and translational) researchers who are engaged in studies that will be part of a clinical development program and require oversight from a regulatory agency, such as the FDA, USDA, and EPA. The Clinical and Translational Regulatory Support office interacts with the regulatory agency and promotes consistency with national standards and best practices. For more information, contact Dr. Tracy Webb.
Translational Informatics Support
The Translational Informatics Support office provides tools to assist in managing data for studies involving human subjects research, veterinary clinical research, and Good Practices (GxP) research, and tools for managing biobank repositories. The office promotes consistency with national standards and best practices.
- Implementation of secure, compliant web applications for human clinical and veterinary clinical studies – including HIPAA compliant systems such as REDCap – for more information, contact John Hayes. FDA provides guidance on requirements for computerized systems used in human clinical trials.
- Implementation of secure, compliant web applications for GxP studies – for more information, contact John Hayes.
- Setting up data dashboards for reporting aggregated data – for more information, contact John Hayes or Cory Hudson.
- Strategies for data analytics, ETL (Extract, Transform, and Load), and data integration across disparate data sources (spreadsheets, relational databases, REDCap, etc.) – for more information,contact John Hayes or Cory Hudson.
- Implementation and management of biobank repositories using LabKey’s Sample Manager, a cloud-based sample management software providing complete sample tracking, freezer management, lab workflow management, and compliance features – for more information,contact Cory Hudson.
- Use of Computers in Research