Clinical Coordinating Center

• 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
• 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

Disclaimer: The Clinical Coordinating Center of the NHLBI Gene Therapy Resource Program does not and will not hold the IND or serve as Study Sponsor in any capacity. Further, when providing assistance to an NHLBI-approved investigator in the preparation of any regulatory or regulatory-related document(s), the responsibilities of the IND-Sponsor and/or the Principal Investigator of the study cannot be delegated or assigned in any way to the Clinical Coordinating Center.

Assistance with Food and Drug Administration (FDA)

• Assist in the preparation of INTERACT submissions in accordance with the Center for Biologics Evaluation and Research (CBER) SOPP 8214 entitled, 'INTERACT Meetings with Sponsors for Drugs and Biological Products'.
• Assist in the preparation of Pre-IND submissions in accordance with "Guidance for Industry - Formal Meetings Between FDA and Sponsors or Applicants"
• Assist in administrative preparation of IND submission in compliance with 21CFR312
• Assist with submission of serious and unexpected adverse events that occurred in the course of the trial
• Assist in submission of IND annual report for FDA review

Assistance with NHLBI Requirements

• Assist with submission of final, approved clinical protocol to NHLBI
• Assist with submission of serious and unexpected adverse events that occurred in the course of the trial to NHLBI
• Assist with NHLBI-required study reports for clinical trials funded by the GTRP

Assistance with Institutional Biosafety Committee (IBC)

• Assist in securing IBC for sites without a standing IBC
• Assist with registration of the IBC with NIH-Office of Science Policy (OSP)
• Assist in compiling documents required for IBC review including relevant communications from the FDA and NHLBI
• Assist in responding to IBC comments, modifications and recommendations
• Assist with submission of annual reports of studies for IBC review

Assistance with Institutional Review Board (IRB)

• Assist in compiling documents required for IRB review including relevant communications from the FDA and NHLBI
• Assist with submission of serious and unexpected adverse events that occurred in the course of a clinical trial
• Assist with submission of annual reports of studies for IRB review

Assistance with Data and Safety Monitoring Board (DSMB)

• Assist in compiling documents required for DSMB review
• Assist with submission of serious and unexpected adverse events that occurred in the course of the trial

GTRP Clinical Trial Funding Assistance Administered by the CCC

Registered investigators may submit a Request for Service Application (RSA) for Clinical Trials Funding Assistance through the NHLBI Gene Therapy Resource Program (GTRP). NHLBI’s Gene Therapy Group reviews such RSAs and determines the amount of funding that can be provided through the program, if any, and any contingencies relevant to the particular study and RSA. The CCC acts as the contractual agent for this component of the program and manages the disbursement of funds. Further, the CCC provides support to the GTRP in the oversight of study/investigator compliance with regulatory requirements and any study-specific contingencies related to funds disbursement.

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:

For Phase I or II Clinical Trial Funding Assistance the applicant must:

• Be an NHLBI investigator
• Provide the clinical protocol for which funding is sought
• Provide an implementation plan for recruitment and enrollment of research participants
• Provide documentation of any secured financial support for the clinical trial

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:

• Description of the study related to the service request
• Level of available funding for the study
• Regulatory status of the study

Additionally, for Regulatory Assistance:

• Specifics about the regulatory support needed
• Timeline for the assistance

Additionally, for Clinical Trial Funding Assistance:

• Co-investigator information
• A detailed protocol budget

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