The objective of the Regulatory Compliance and Informatics Core is to provide a responsive infrastructure of regulatory and data management expertise for the three Projects in this U19 application. In the current application, we improve on the ideas and experience of the first Regulatory Core established within the IP/CP U19 Program. This group was developed within the Microbicide Development Program (AI060614), and it was remarkably successful in instituting cross-institutional synchrony in regulatory issues, in reducing duplication efforts, developing the common data entry and analysis format, and establishing clear and rapid response channels for clinical trials. This is especially critical in this ambitious application with human subjects used in Project 1, animal experiments in Project 2, and multiple interactions with FDA and other institutions to meet timelines for the three exploratory trials in Project 3. There is strong rationale for the inclusion of co-Leaders for this Core from CONRAD (Dr. Henry Gabelnick - NB: CONRAD holds all licensing related to products in this application) and UCLA (Dr. Peter Anton will supervise the experienced regulatory team there.) CONRAD is uniquely qualified to be co-leader of this Core due to its vast experience with various regulatory agencies, especially FDA, as well as its licensing and exemplary regulatory affairs branch. UCLA will provide a critical, academically evolved regulatory group to complement and provide the hands-on, day-to-day management and support required for Projects. In addition, the Informatics portion of the Core will focus on implementing software that enforces compliance in the matters of privacy, integrity of research data and the identities of human participants. Saving costs is a motivation for combining two previous Cores into one;but more importantly, there is a natural synergy between these two enterprises, as we have successfully demonstrated in the previous U19 Program. By building on many of the innovations and services in place from the first U19, we can support the needs of the CHARM Program, realize significant savings, and leverage experience. Moreover, focusing Informatics efforts on regulatory compliance will enhance our expertise in data collection, management, and reporting, where we can ill-afford inefficiency and shortsightedness. .

Public Health Relevance

This Core is essential for regulatory guidance and education, and by working closely with Project Leaders and their teams, it will work to streamline regulatory management practices. It will assist with complex navigation of research compliance (including IRB and HIPAA), work on creating a system of effective Quality Assurance practices, and standardize the regulatory and data management approach across various research projects (basic science, animal, and human). In addition, the Informatics component will facilitate the flow of scientific information between and within Projects and Cores communication

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Program--Cooperative Agreements (U19)
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Special Emphasis Panel (ZAI1-BP-A (J1))
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Magee-Women's Research Institute and Foundation
United States
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McGowan, Ian (2014) The development of rectal microbicides for HIV prevention. Expert Opin Drug Deliv 11:69-82
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