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 Principal Investigator: Susan B. Sepelak, M.S., M.S.M. The Gene Therapy Resource Program’s (GTRP) Clinical Coordinating Center (CCC) at Social & Scientific Systems, Silver Spring, Maryland provides management and logistical support to the NHLBI Gene Therapy Group in program operation. This includes providing support for all activities related to the development, implementation, and maintenance of the program’s operational infrastructure. The Principal Investigator of the CCC serves as a member of the GTRP Steering Committee. CCC staff members meet frequently with the NHLBI Gene Therapy Group regarding program policies, procedures, and activities. Registered investigators may contact the CCC for assistance in answering a regulatory question by sending an email inquiry to CCCemail. The CCC provides regulatory support for larger efforts via the Request for Services Application (RSA) process. In addition, the CCC administers the disbursement of funds for clinical trial support as approved by the NHLBI Gene Therapy Group through the RSA process. Responsibilities When mailing forms or other documents to the GTRP Clinical Coordinating Center be sure to reference the related RSA number or study title. Please use the following address: Social & Scientific Systems, Inc. For Phase I or II Clinical Trial Funding Assistance the applicant must:
For Regulatory Support the applicant must be, or have been, an NHLBI grantee. However, the gene therapy project for which the regulatory assistance is requested does not have to be part of an NHLBI grant. A Request for Service Application (RSA) is the mechanism for applying for GTRP resources. Investigators must register on-line and be approved by the NHLBI Gene Therapy Group in order to access the Request for Service Application. All applicant investigators will need to provide:
Additionally, for Regulatory Assistance:
Additionally, for Clinical Trial Funding Assistance:
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