Committees

Executive Committee

The Executive Committee ensures the CSRC is in concert with its charter mission. In addition, it oversees all committee activities and reviews each committee’s recommendations. The Executive Committee holds final decision making responsibility for all CSRC activities and processes. It also has final responsibility for providing all in-kind and fiscal resources, or strategies and support for obtaining such resources, needed to facilitate each committee’s activities on behalf of the CSRC. The Executive Committee determines replacements for CSRC leadership roles if need be.

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Membership Committee

The Membership Committee is the primary center of activity that sustains the vitality of the CSRC by recruiting new members and ensuring members have opportunities to participate and contribute to the organization at every level. The committee is responsible for determining membership statuses of new applicants according to stipulations outlined in the membership charter.

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Inter-Organizational Partnership Liaison Committee

The Inter-Organizational Partnership Liaison Committee serves as the CSRC's "single point of contact" for partner organizations and facilitates jointly sponsored meetings and publications. Although partner organizations are not members of the CSRC, they share the neutrality and patient-centered goals of the consortium.

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Scientific Oversight Committee (SOC)

The SOC is the primary intellectual repository for solicitation, review, and ongoing oversight of all scientific projects and programs, making recommendations on each directly to the Executive Committee. The SOC develops and facilitates research teams specifically dedicated to each approved research program.

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Scientific Programs Committee

The Scientific Programs Committee organizes and provides logistical support for all CSRC-sponsored public meetings. Although this committee is separate from the SOC and other committees, it works in an integrated fashion to ensure appropriate topics are raised to the Executive Committee for consideration from various CSRC groups. This committee reviews proposals for annual meetings, think tanks, and other public forums, specifically focusing on meetings that will likely catalyze other sustained efforts such as white papers and research projects. In addition, the Scientific Programs Committee assists in forming specific working groups as needed to provide direction, guidance, administrative support, communications, and involvement with other facets of CSRC.

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White Papers and Publications Committee

The White Papers and Publications Committee orchestrates and provides logistical support for all CSRC-sponsored publications. Although this committee is separate from other committees, it is intended to work in an integrated fashion to ensure that appropriate topics are raised to the SOC for consideration from the various CSRC groups. Committee members review proposals for white papers and similar publications, focusing on topics that either emerge from or will likely catalyze other sustained efforts, such as research projects, public meetings, and programs. The White Papers and Publications Committee assists in forming specific writing and reviewer groups as needed to provide direction, guidance, administrative support, communications, and involvement with other facets of CSRC. Committee membership consists of at least industry, academia, and regulators. It reports through the SOC.

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ECG Database Committee

ECG data in the ECG warehouse are owned by specific entities. Most typically these are pharmaceutical company sponsors that submit ECGs in the course of drug development or post-market surveillance. In other scenarios, they can be research organizations (public or private) that collaborate with CSRC for shared common scientific goals.

Release of ECG data to CSRC for additional analysis represents a collaborative effort of scientific goodwill on the part of the data owners. Within the CSRC, the ECG Database Committee covers all technical sides related to project proposals (before their submission) and subsequent data analysis (after the projects have been executed). The Scientific Oversight Committee (SOC) evaluates proposals for use of the released ECG data and fosters collaboration within the research community. Individual research protocols cleared by the SOC are then approved by the Executive Committee.

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Organization

Executive Committee Scientific Oversight Committee Membership Committee Public & Educational Programs Committee ECG Database Committee Partnership Liaison Committee White Papers & Publications Committee

 

Committee Tasks and Responsibilities:

Executive Committee:

  • Ensure that all activities are commensurate with the CSRC mission through oversight of all committee activities
  • Ensure development of operational infrastructure in order to orchestrate and facilitate CSRC activities and committees
  • Form ad hoc advisory groups or committees as needed

Scientific Oversight Committee (SOC):

  • Solicit and review scientific project proposals.
  • Recommend project proposals to the Executive Committee for final approval.
  • Form and support Project Teams specific to implementation of approved projects
  • Provide ongoing oversight and facilitation of Project Team activities, timelines and deliverables
  • Support and facilitate leadership and activities of the White Paper and Publications committee

Membership Committee:

  • Develop and maintain CSRC informational materials for potential new members
  • Solicit, and provide support and outreach for potential members
  • Evaluate applications for CSRC membership and present proposals to the Executive Committee
  • Determine level of membership (Sustaining/Principal/Associate)
  • Provide information on and facilitate new members opportunities within the CSRC
  • Periodic review of membership composition and participation

Public & Educational Programs Committee:

  • Identify and prioritize topical themes for think-tank/incubator meetings and Annual Meeting
  • Ensure the Annual CSRC meeting
  • Develop meeting planning teams for each specific meeting
  • Provide oversight and facilitate the activities of each specific Meeting Planning Team
  • Define the composition of each specific Meeting Planning Teams

ECG Database Committee:

  • Identify and prioritize potential research projects and uses for the CSRC ECG Warehouse data
  • Identify and solicit potential data that could be added to the CSRC ECG Warehouse
  • Ensure fair access to the CSRC ECG Warehouse data, including methods for obtaining data
  • Ensure statistical analysis requests can be fulfilled based on staff and budget
  • Recommend project proposals to the SOC/Executive Committee for final approval
  • Provide ongoing oversight and facilitation of research projects, including timelines and deliverables

Partnership Liaison Committee:

  • Focus on interactions with external organizations and identify a “single point of contact” liaison within each organization
  • Encourage participation by organizations in CSRC sponsored activities including our Annual Meeting, and discuss
    if/when/how CSCR can participate in organizations’ Annual Meetings

White Paper & Publications Committee:

  • Develop and support writing and reviewer groups, which will draft white papers in challenging areas describing
    what is known, unknown, and proposing paths forward to address such knowledge gaps

Research Teams:

  • SOC-approved research project conduct & reporting

Scientific Rationale

Safety is a critical component of medical product development and approval. In particular, cardiac safety has received intense focus with several high-profile issues, including market withdrawals. These concerns have stimulated debate over the best way to measure efficacy while ensuring the protection of the public health. At the center of this debate is the balance between efficacy and safety. Importantly, rapid advances in therapeutic medical product development have yet to reach full potential, in part due to limitations in our ability to understand and quantitate therapeutic balance.

Unfortunately, the evaluative sciences surrounding medical product approval have not kept pace with our fundamental understanding of disease. Societal investment in research and development to improve the approval process lacks in contrast to the large public and private investment in basic research and specific product advances. To improve the ability of regulatory agencies to promote and protect the public health, there needs to be a fundamental investment in the evaluative sciences. Specifically, the scientific basis of our understanding of medical product safety needs to be enhanced and integrated with refined measurements of efficacy. An investment in the evaluative sciences will provide more precise, scientifically-based information, enabling healthcare professionals and patients to appropriately assess risks and benefits.

The FDA's Critical Path Initiative (CPI) addresses many of these issues by establishing greater collaboration among regulators, academics, physicians, and scientists from industry. The spirit of this collaboration creates opportunities by sharing existing knowledge and data that will facilitate the process of enhancing, refining, and ultimately improving the process used to evaluate new medical products. A central tenet to CPI is focusing on the evaluative science of the approval process, including both efficacy and safety measures.

One of the CSRC's core principles is to bring together key constituencies to focus on cardiac safety issues during the new medical product development process. Utilizing the principles of CPI, CSRC will focus on improving the evaluative sciences, specifically in relation to cardiac safety.

Mission and Program Objectives

Mission

To advance scientific knowledge on cardiac safety for new and existing medical products by building a collaborative environment based upon the principles of the FDA’s Critical Path Initiative as well as other public health priorities.

Key Objectives

  1. To facilitate focused pragmatic research that will inform regulatory processes with regard to cardiac safety
  2. To develop expert consensus around common nomenclature, standards, and key definitions, and to draft white papers in challenging areas, describing what is known and unknown, and proposing paths forward to address such knowledge gaps
  3. To develop knowledge and strategies intended to improve the evaluative sciences in relation to cardiac safety and product development
  4. To coordinate think tanks, scientific meetings, and public forums for open discussion and updates on topics in cardiovascular safety pertaining to drug and device development
  5. To establish infrastructure and operational processes with the following components:
    • Transparent processes that promote dialogue, cross-sector interaction, and problem solving
    • Inclusion of broader public or patient groups in the process as appropriate
    • Input from all primary stakeholders (e.g., FDA, industry, academia, NIH)
    • Involvement from all consortium contributors (i.e., private partners who help fund the consortium's activities) in the decision-making and project development process
    • Resources and expertise from multiple public and private partners
    • Open and efficient method for submitting potential projects and their objective evaluation
    • Facilitation and, where appropriate, orchestration of mechanisms for continuance of ongoing cardiac safety research programs
    • Utilization of previously conducted and ongoing clinical studies, research infrastructure, and databases
    • Preservation of proprietary interests

About Us

The Cardiac Safety Research Consortium (CSRC) was launched in 2006 through an MOU with Duke University to support research into the evaluation of cardiac safety of medical products. CSRC supports research by engaging stakeholders from industry, academia, and government to share data and expertise. Outputs of the CSRC include research projects utilizing waveform data released by the FDA ECG warehouse, think tank programs, and consensus white papers.

 

Our Core Values