• Mission Statement
  
• Executive Committee
  
• Standing Committees
  
• Institutional Principle Investigators
  
• Institution of Studies
  
• For More Information
  
• Bibliography
  

Mission Statement

The Pediatric Critical Care Study Group is an organization comprising tertiary Pediatric Intensive Care Units with an interest in and commitment to multi-institutional clinical research in Pediatric Critical Care.

The purpose of the PCCSG is to provide an organizational infrastructure to facilitate the conduct of these projects, including resources to assist in project design, protocol development, and data collection and analysis. In addition, while not providing funding directly to individual projects, the PCCSG will have access to resources and will provide assistance to project principal investigators in the seeking of financial support.

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Executive Committee

Composition. The primary governing body for the PCCSG will be the Executive Committee. Members of this committee will include four ex-officio members and 8 at-large members. The ex-officio members will include the designated representative from the National Institute for Child Health and Human Development, the Chairpersons of the Protocol Review Committee, the Finances Committee, and the Patient Registry Project Committee.

The at-large members will be elected by a plurality vote of the institutional principal investigators, following candidate nomination by the PI's. These members will serve terms of four years, with elections held each year for two of the at-large positions.

To be eligible for nomination to the Executive Committee requires that the individual a) be a current institutional PI, a charter member of the Executive Committee, or an individual selected by other Comrnittee members for his or her proven and exceptional skills in clinical research; and b) have demonstrated interest in and commitment to clinical research.

Responsibilities. The Executive Cornmittee is responsible for the general oversight of all PCCSG operations and activities. These responsibilities include:

• the creation and revision as necessary of written policies and procedures, and the determination of institutional membership criteria;
• oversight of the Patient Registry Project, including the collection of and access to all data collected therein;
• final approval of all research project protocol proposals;
• approval of all funding source solicitation;
• approval of all fund expenditures.

Meetings. The Executive Committee will meet two times per year. These meetings will be scheduled to coincide with major national meetings, such as the Society of Critical Care Medicine meeting and the Pediatric Critical Care Colloquium. Other meetings may be called as necessary by the Chairman.

Executive Committee Chairman. The Chairman of the Executive Committee will be a current or past member of the Executive Committee, will serve as the PI for the PCCSG as a whole, and will serve a term of five years. He will be nominated and elected by majority vote of members of the Committee. The institution of the Chairman will serve as the home base of the PCCSG during that individual's term.

The Chairman will be responsible for the following:

• general administrative oversight of the PCCSG
• leadership of the Executive Committee;
• managing PCCSG office staff;
• oversight of the distribution of protocols and related information;
• regular and ongoing communication with institutional PI' s;
• maintenance of membership information through a database in a manner which includes mechanisms for guaranteeing institutional and subject anonymity.

The PCCSG shall assist in the providing of adequate support to the Chairman for the fulfillment of these responsibilities, including clerical support, access to legal consultation, and access to a grant-writing consultant.

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Standing Committees

• Protocol Review Committee
• Patient Registry Project Committee
• Finances Committee

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Institutional Principle Investigators

Each PCCSG participating institution will have one individual designated as its Principal Investigator. This individual will be chosen by mechanisms determined by each institution without involvement of the PCCSG per se.

Each institutional PI will be responsible for the following:

• decisions about that institution's participation or non-participation in each PCCSG approved study;
• total oversight of all data collection for individual studies and accountability for data integrlty;
• assurance of compliance with all intra-institutional policies and procedures, including the securing of Institutional Review Board approval;
• timely provision of collected data for individual projects to approved data collection site;
• oversight of Patient Registry Project data collection, and monthly (or as otherwise specified by Patient Registry Project Committee) provision of data to central data storage site.

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Institution of Studies

Brief Project Description. An investigator who wishes to submit a proposal for consideration by the PCCSG must first submit in writing a brief project description to the Executive Committee Chairman. This description not more than three pages in length, should follow standard format: Background/Introductory Remarks; Statement of Study Aims; Statement of Hypothesis to be Tested; Description of Materials and Mlethods to be used, including a description of the subjects involved in the study; and a Description of Anticipated Analytical Methods (statistics).

The project description should be accompanied by a cover letter from the investigator describing 1) general merit of the study; 2) reasons that multi-institutional design is required; and 3) assessment of the feasibility and logistical difficulty for the participating institutions, including as estimate of time commitment required.

The brief project description is then forwarded to the Chairman of the Protocol Review Committee who critique the proposal and recommend a disposition to the Executive Committee. If the project proposal is denied, the Executive Committee Chairman and/or the Protocol Review Committee Chairman will communicate in writing this decision to the author of the proposal. If the project is approved, the author is contacted and provided information about requirements for the detailed proposal draft.

Detailed Proposal Draft. Once completed, the detailed project proposal draft is reviewed by the Protocol Review Committee (see description of Protocol Review Committee responsibilities). This committee ascertains local IRB approval and recommends any needed protocol revisions to the project's author through the PR Committee Chairman. Upon acceptance of revisions by the Project PI (proposal author) and final approval of the project by the Protocol Review Committee, PCCSG member institutions will be solicited for participation by the Executive Committee Chairman.

The Executive Committee Chairman will also be responsible for securement from Institutional PI's their IRB approval statements, Participation Intent Forrns, and other project-dependent materials, and for maintaining these documents.

Executive Committee

Greg Stidham, Memphis, TN. Chair
Jeff Blumer, Cleveland, OH
Michael Dean, Salt Lake City, UT
Tom Green, Chicago, IL
James Royall, Iowa City, IA
Curt Steinhart, Augusta, GA
Carl Weigle, Milwaukee, WI
Tim Yeh, Oakland, CA
Arno Zaritsky, Norfolk, VA
Frank Moler, Ann Arbor, MI. Protocol Committee Chair
Steven Pon, New York, NY. Patient Registry Project Chair

For more information regarding the PCCSG or protocol submissions, contact:
Greg Stidham
Chairman, PCCSG
LeBonheur Children's Hospital
848 Adams Avenue
Memphis, TN 38103

Phone: 901-572-3132
Fax: 901-572-5198
Email: fishley@aol.com