Specific Responsibilities of the CCC

• Development of program policies and bylaws
• Development of systems including processes and forms for receipt, review, disposition, and tracking of investigator initiated Request for Services Applications (RSAs)
• Development and maintenance of Standard Operating Procedures and associated forms and checklists
• Development and maintenance of the GTRP database and website
• Planning, preparation, logistical support and conduct of Steering Committee meetings, subcommittee and working group meetings, and scientific meetings organized by the GTRP
• Support for NHLBI Data Safety Monitoring Board (DSMB) members reviewing GTRP funded studies
• Preparation of meeting minutes for Steering Committee, DSMB (open session), ad hoc program meetings, scientific meetings
• Assistance in the development and placement of GTRP promotional materials
• Regulatory compliance management support regarding laboratory accreditation, licensing, certification
• Regulatory compliance management support regarding investigator submitted RSAs and the required associated documentation
• Regulatory support to investigators in preparing Investigational New Drug applications, in securing an Institutional Bioethics Committee
• Regulatory support to investigators in the interpretation and application of guidelines and processes for interaction with the Food and Drug Administration and other regulatory bodies
• Regulatory support to investigators in report preparation for DSMB and other required meetings