Uniform Reporting Format

The submission must be formatted in a manner that is consistent with the requirements of the regulatory agency that will review the submission. The dossier may include 20 or more individual clinical trial reports. They should be uniform in format to assist the reader to assimilate evidence readily and to compare it between trials. The whole dossier should be one of accuracy, consistency and meticulous cross-referencing. Once again, the effort to reach these objectives must be made in the early planning stages. 

A logical extension of the uniform global testing protocols is a imiform data reporting format. Standardization of the format for reporting data is deemed essential to facilitate the much desired apples-to-apples comparison among thousands of materials available from different suppliers around the world. Part 2 of the ISO material standards for each material attempts to address this issue by employing a uniform data template selected from Table 2 in ISO 10350-1 standard for comparable data. 

Effect of Rock Permeability. The effect of rock permeability has been investigated by comparison of mobility measurements made with Baker dolomite and Berea sandstone. Mobility measurements carried out with Rock Creek sandstone (from the Big Injun formation in Roane County, W.Va) is also reported. Rock Creek sandstone has a permeability of 14.8 md. A direct comparison was made with Berea sandstone and Baker dolomite measured with 0.1% AEGS. As mentioned in an earlier section, the permeability of Baker dolomite (a quarried carbonate rock of rather uniform texture with microscopic vugs distributed throughout) was 6.09 md, and of Berea sandstone was 305 md. The single phase permeabilities were measured with 1% brine solution. 

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