GENE THERAPY RESOURCE PROGRAM (GTRP) Header
GENE THERAPY RESOURCE PROGRAM (GTRP) Header
HIGHLIGHTS
RSA Submissions are Accepted on a Continuous Basis

» Instructions for Submitting
  an RSA

» RSA Review Process
INFORMATION CENTER

» Regulatory Guidelines

» GTRP Presentations at the
  ASGT Meeting May 28, 2008

» NHLBI Home

CLINICAL COORDINATING CENTER Header

Principal Investigator:  Micheal Gilbreath, Ph.D.
Project Coordinator:  Susan B. Sepelak, M.S., M.S.M.

Introduction

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
Regulatory Support
Funding Administration

Submit Documents to the CCC

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.
GTRP Clinical Coordinating Center
8757 Georgia Avenue
10th Floor
Silver Spring, MD 20910

FAQs

Who can apply for these GTRP resources?

For all types of RSAs

  • The scientific research in gene therapy that is the subject of the RSA must be consistent with the NHLBI Mission (http://www.nhlbi.nih.gov/about/org/mission.htm).
  • The submitting investigator must be registered and approved as described under
    “Who Can Submit an RSA?”
  • RSA approval and implementation is contingent upon availability of funds in the GTRP. 
  • Services provided through an approved RSA are at no cost to the investigator.
  • The various types of RSAs are independent of one another.  An applicant Investigator may submit any type of RSA for a qualified gene therapy research project regardless of past or future utilization of GTRP resources for the project.

In addition,

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.

What is the mechanism for obtaining these GTRP resources?

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.

What type of information will the approved applicant investigator need to provide on 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


About SSS

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Contact the CCC: CCCemail
Investigator Registration | Request for Service Application | Core Laboratories | Scientific Review Board | Steering Committee | NHLBI Gene Therapy Group