In the spring of 1995, Dr. Harold Varmus convened a panel to review the status of clinical research in the United States and to make recommendations to the Advisory Committee and to the Director of the NIH about how to ensure its effective continuance. The panel made several recommendations that addressed: (A) Data concerning clinical research and methods of reviewing clinical research, (B) Training and support for clinical investigators and (C) The scope of GCRCs and the Clinical Center. One topic not addressed by the panel was the data generated by the General Clinical Research Centers (GCRCs) and its impact on each of these areas. While the GCRCs provide advanced information technology to investigators and support staff, the technology is not currently being used to effectively combine clinical, laboratory and statistical data for use within and between Centers. This proposal requests support for five annual GCRC informatics meetings. The objectives of these meetings will be: 1) To demonstrate, reinforce, enhance and stimulate informatics technology which is and/or will be utilized at the Centers; 2) To define a set of guidelines for the collection and management of clinical, laboratory and analytical data generated at each Center; 3) To identify technologies that will allow the secure and confidential storage, access and transmission of data within and between Centers; 4) To provide informatics education and training for GCRC systems managers and biostatisticians; 5) To encourage multicenter research and the sharing of Center resources through the use of informatics technologies and practices. These meetings will encourage dialogue within the GCRC community, that will promote the effective exchange of ideas, provide new opportunities for the use of informatics technologies in patient-oriented research initiatives and enhance the overall effectiveness of the GCRC Program. To ensure that these objectives are accomplished, a Steering Committee is proposed. This committee, which will be composed of representatives of the national GCRC network and the NIH, will communicate using electronic mail and will meet quarterly via conference calls. The committee will include the Meeting Chairperson, who will be selected each year by the Executive Board of the Association of GCRC Systems Managers (AGSM), a representative of the AGSM, a representative of the Association of GCRC Statisticians (AGS), a representative of the GCRC Program Directors Association, a representative from the NIH GCRC Program staff, and a representative from Meetings Plus, the conference organizer (this individual will be responsible for scheduling the conference calls). Each two-day meeting will be held at a site determined by the Meeting Chairperson at a time that does not conflict with the annual GCRC Program meeting. It is anticipated that attendance will be 150 individuals (two persons from each GCRC Center).
