Normal ranges, laboratory data

A laboratory shift table is a tabular display that can show you how a population s laboratory data change, or shift, over time. Often you want to see what happens to the patients lab values after therapeutic intervention. Did certain lab parameters drop below or above normal range Are there laboratory tests that have become of clinical concern A shift table can provide this information at a glance. Although the example that follows is focused on laboratory data, a shift table can be used to show the movement of any categorical data over time. 

The following is a table specification for a laboratory normal range shift table. In order to create this table, you need to have a laboratory data set where the lab values have been flagged as normal, low, or high. The highlighted items in the table shell are parameters that change for the laboratory data in the study. 

A further advancement comes from inter-laboratory comparison of two standards having different isotopic composition that can be used for a normalization procedure correcting for all proportional errors due to mass spechomehy and to sample preparation. Ideally, the two standard samples should have isotope raUos as different as possible, but still within the range of natural variations. There are, however, some problems connected with data normalization, which are still under debate. For example, the CO2 equilibration of waters and the acid extraction of CO2 from carbonates are indirect analytical procedures, involving temperature-dependent fractionation factors (whose values are not beyond experimental uncertainties) with respect to the original samples and which might be re-evaluated on the normalized scale. 

Normal values/ranges for laboratory data -dated and signed by laboratory/investigator including updates... 

References ranges and sources of error The trends in data or individual abnormal values are only interpretable if the reference values are known and the test is reliable. Reference ranges usually refer to the mean value and two standard deviations on either side of the mean. Thus 95% of a sample population who are free of disease will fall inside this range, with 2.5% above and 2.5% below. The sponsor should know the source of subjects who provide this normal range, and most laboratories periodically update their ranges of reference values to reflect the population they serve. Reliability indicates that the test is consistent over time and a reliable test correlates highly with successive measures. 

It is common practice to employ outside laboratories to perform testing for safety and efficacy measures in clinical trials. Along with the results, these laboratories will also provide the units and normal ranges for the tests performed. Since the laboratories are typically utilized by many patients in a study or even across studies, it is practical for the units and ranges to be received and entered once in the system and then linked internally to the patient data to which they apply. This principle of centrally storing values that can be shared across the system is also desirable for maintaining the conversion factors used in deriving lab results into standardized units. 

To develop a data management plan pertinent to the project, a checklist of the project material is necessary to enhance the planning. The items to be collected include the protocol, annotated case report forms (CRFs), literature, log-in and tracking forms, file structures, coding rules, CRF review conventions, query handling procedure, required edit checklist, central laboratory address/file format, laboratory normal ranges, clinically... 

A subsection on Clinical Laboratory Evaluations is to describe changes in patterns of laboratory tests with drug candidate use. As mentioned earlier, marked laboratory abnormalities and those that led to a substantial intervention are to be reported in the subsection on SAEs. The appropriate evaluations of laboratory values will usually be determined by the results observed and should include comparison of the treatment and control groups. Normal laboratory ranges, given in standard international units, should be provided for each analyte measured. A brief overview of the major changes in laboratory data (e.g., hematology, clinical chemistry, urinalysis, and other data as appropriate) at each time (e.g., at each clinical visit) over the course of the studies should include information on... 

UI concentration will follow throughout their pregnancy. Trimester-specific data determined by lA and tandem mass spectrometry are now available and can facilitate comparisons across different laboratories and populations. The availability of the normal ranges of TH concentrations throughout pregnancy allows individualized thyroxine therapy, as well as iodine supplementation when necessary. 

Chuang-Stein C (2001) Some issues concerning the normalization of laboratory data based on reference ranges. Drug Information Journal 35 153-156. 

Based on the above equilibria, the concentration of HOCl in the normal pH range varies inversely with the total concentration of cyanurate. Increased concentration of cyanuric acid, therefore, should decrease the biocidal effectiveness of FAC. This has been confirmed by laboratory studies in buffered distilled water which showed 99% kill times of S.faecalis at 20°C increasing linearly with increasing cyanuric acid concentration at constant av. Cl at pH 7 and 9 (45). Other studies in distilled water have found a similar effect of cyanuric acid on kill times of bacteria (46—48). Calculations based on the data from Ref. 45 show that the kill times are highly correlated to the HOCl concentration and poorly to the concentration of the various chloroisocyanurates, indicating that HOCl is the active bactericide in stabilized pools (49). 

A data plot, as displayed in Fig. 4-15, may then constitute a useful support for the simple selection of candidate CSPs that should be available in a laboratory. For purposes of comparison, luminance data were scaled by normalizing the data in the range [0,100] by means of the following equation ... 

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