Funding Submissions

Compliance is not a standalone element of a grant or contract; compliance is integrated in the design, conduct, and oversight of a regulated nonclinical study (or series of studies). If the funding agency requires GLP compliance (or mentions GLP as a reference standard) and/or if the study satisfies the scope of the GLP regulations, or Animal Rule, and the sponsor intends to submit the data to the Agency for a regulatory decision, contact ORNcS for review prior to submission. Regulated studies require a combination of scientific expertise and independent regulatory oversight. A significant increase in personnel, time, and effort is required to assure compliance.

Additionally, sponsors may require elements of GLP to assure data quality and integrity and to enhance efficiency by more rapidly progressing products through the regulatory pipeline. Some sponsors may view the requirement as a risk-based business decision whereas others may include elements to enhance the rigor and reproducibility of the study(ies). Sponsors may also have received feedback from the FDA and prospectively included the requirement.  ORNcS can assist UTMB investigators during preliminary discussions with prospective sponsors to determine the necessity for, and appropriateness of, GLP quality system elements for their planned scope of work.

Per UTMB IHOP Policy 11.02.01 Institutional Office of Regulated Nonclinical Studies, “ORNcS is required to be involved in all studies regarding any material or mention of GLP standards…”

Contact Dr. David Beasley, Ms. Melissa Eitzen, or send a general email inquiry to for more information or to request a review.