NHEXAS PHASE I REGION 5 STUDY--STANDARD OPERATING PROCEDURE FOR PREPARATION OF A PROTOCOL (NHX/SOP-100-003)

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Abstract

This procedure describes the preparation of protocols as part of the quality assurance program for the Region 5 NHEXAS study. In general, protocols describe the objectives, methods, and procedures used to conduct a study or experiment. A protocol may include some detailed information specific to a program area, but typically a protocol is prepared as an overview and guide, rather than a set of step-by-step instructions. For the Region 5 NHEXAS Study, protocols provided an overview of complex operations. The protocol format was sufficiently flexible to accommodate a variety of information types or developing methodologies. This procedure provides example components of a protocol. Keywords: standard operating procedure; protocol; quality assurance program.

The National Human Exposure Assessment Survey (NHEXAS) is a federal interagency research effort coordinated by the Environmental Protection Agency (EPA), Office of Research and Development (ORD). Phase I consists of demonstration/scoping studies using probability-based sampling designs. The Region 5 study was conducted in EPA's Region 5 (Ohio, Michigan, Illinois, Indiana, Wisconsin, and Minnesota), and included personal exposure, residential concentration, and biomarker measurements of metals and VOCs. The study was conducted by the Research Triangle Institute (RTI) and the Environmental and Occupational Health Sciences Institute (EOHSI). The scope and design of the study are detailed in the following article: E. Pellizzari et al., Population-Based Exposure Measurements in EPA Region 5: A Phase I Field Study in Support of the National Human Exposure Assessment Survey. Journal of Exposure Analysis and Environmental Epidemiology, Vol. 5, No. 3, 1995, pp. 327-358.

NOTE: The U.S. Environmental Protection Agency (EPA), through its Office of Research and Development (ORD), partially funded and collaborated in the research described here. Mention of trade names or commercial products does not constitute endorsement or recommendation by EPA for use. This SOP is part of the Quality Systems Implementation Plan (QSIP) that was reviewed by the EPA and approved for use in this demonstration/scoping study. This SOP was used in the study and is provided for documentation purposes. It does not reflect EPA methods and should not be construed as such. The methods were generated by the consortium to be used for the NHEXAS pilot study.


Citation

Region 5 Study Consortium. NHEXAS PHASE I REGION 5 STUDY--STANDARD OPERATING PROCEDURE FOR PREPARATION OF A PROTOCOL (NHX/SOP-100-003). U.S. Environmental Protection Agency, Washington, D.C., 1995.

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