The mission of the Regulatory Affairs Department is to gain approval from the various Institutional Review Boards and other applicable committees so that patients may be enrolled in investigational studies provided by the IDD. The Regulatory Affairs Department follows FDA and GCP guidelines for every study to ensure all federal and industry requirements are met. Computerized systems are accessible by all members of the organization so they have the most current information regarding studies at any given time. For sponsors, the department handles the processing of 1572's, financial disclosure forms, and laboratory certifications and normal ranges. Other responsibilities include adverse event reporting, protocol amendments, annual re-approvals, the study archives database, and annual progress reports to the NCI. In 2011, with the assistance of the IT Department, Regulatory Affairs went live with a website allowing representatives of the Sponsor and CRO remote access to essential regulatory documents.
For additional information, contact:
Ellen R. Jones, CCRP
Regulatory Affairs Manager
CTRC Institute for Drug Development
7979 Wurzbach Rd., Room Z447
San Antonio, TX 78229
Phone: (210) 450-5863