The following pages include several examples of arraying data in formats that make them easy to import and use in any software environment. Data submitted in these formats will expedite regulatory review.
Data Format Types
The General Format is suitable for many types of studies. It includes three related tables. The Individual table contains variables that appear only once, either because they are inherent to the individual unit, such as a subject's sex, or because they are measured only once, such as lesions at necropsy. The Repeated table contains repeated observations on each unit. Observations may be simple replicates, such as assays of replicate vials of a vaccine serial, or they may be sequential observations, such as daily blood cell counts over a two week period. The Variables table contains specific information about the variables presented in the other two tables. This type of information is sometimes called metadata. Download Template and Examples
These formats are suitable for data that are of the form 'positive out of total.' Two examples are given, an animal bioassay and a virus titration. The chief difference between the Bioassay Format and the Titration Format is whether or not a challenge back-titration is included. Most bioassay data sets are relatively simple, have a common data structure, and follow a standard protocol. For that reason, Bioassay Format and Titration Format are simpler than General Format, and a Variables table is usually not necessary. Instead, a simple Comments table may be used. Download Template and Examples
The data from ELISAs and other assays conducted on 96-well microtiter plates may be exported from spectrophotometers as arrayed on the plate. The ELISA Format follows this convention. Except for the Plate Info table, which provides basic information about each plate in the data set, the other tables are laid out as stacked 8×12 arrays. The OD table contains the optical densities, the Layout table indicates the contents of each well, and the Dilution table indicates the dilution of the material in each well.
Tables from different formats may be mixed when there is a need to capture different aspects of a data set. This example shows the use of two different formats for a single study. Download Template and Examples
Softmax Pro. How to export template and OD data directly from the software. An additional table is needed to capture plate-level meta data. Download Template and Examples
Last Modified: September 11, 2013