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Developing resources and services that investigators can use to facilitate and speed the regulatory approval processes at both the Federal and Local levels. These include; 1) Guidance documents and submission templates for the various types of regulatory submissions, 2) Integrating the activities of the Clinical Core with Federal and local regulatory groups in order to establish effective means of communication, 3) Annual Clinical Core reports to regulatory groups that investigators an reference in their own submissions (FDA Drug Master Files, IRB/IBC reports) and 4) Quality Control/Quality Assurance consulting services for clinical investigators who will use UNC Clinical Core products for further manufacturing.

Gene Therapy Associations

Gene Therapy Centers