Raw data definitions

Defining the types of data, for example, meta-data, raw data, definition of data media and formats, and transfer to long-term archivable formats (paper), various PDF formats (see Box PDF) as well as generic formats of chromatographic raw data (NetCDF)... 

When you start working across the Internet, the chromatography data system becomes an open system and the FDA rule requires controls. Using FDA s definition of electronic records, the laboratory chromatography data system generates electronic records. Based upon the definition, laboratories will need to consider more than just the raw data tiles. One must also include the method tiles, mn sequence tiles, and the integration parameters used for the data analysis. The need for a comprehensive audit trail is a critical component of the FDA regulations. The audit trail is an electronic record and is subject to the same controls. 

The definitions are for those words and phrases that the reader encounters in the regulations. Examples include quality assurance unit, raw data, reference substance, sponsor, study, study director, test substance, test system, testing facility. See Box 7.4 for these definitions. 

The operational definition of raw data for the laboratory, especially as they relate to the automated data collection systems used, must be documented by the laboratory and made known to employees. 

The definition of raw data under GLP is more expansive than in non-GLP work. It includes correspondence, notes, phone records, and any document that relates to the interpretation or evaluation of the data. No raw data can be destroyed under any circumstances. 

Starting in about 1978, the Research Directors Committee of the Association began to address the subject. The membership of the committee was polled regarding their views on data retention. This was largely stimulated by proposed EPA guidelines on this matter. I won t attempt to suitmarize the results of that survey, but emerging from it was a consensus definition on the term "raw data," and a consensus statement on retention of saitples. The definition of "raw data" which the industry preferred was as follows ... 

The words "contribute significantly" and "for purposes of registration were key, and represented an important change in the definition vis-a-vis what was proposed by EPA. It was felt that the inclusion of these words would be a more reasonable definition because it reduced the scope of raw data retention to the very type which was needed for validation and which could be reasonably expected to be retained. 

The definition of "raw data" should be clearly understood. It may include items that on gross inspection may appear strange, but raw data are the product of your efforts and must be handled in conformance with the GLPs. 

This paper is concerned with the definition and documentation of primary raw data, or in other words, raw data directly associated with a study. Items such as standard operating procedures, methods, personnel qualifications and training records can be considered secondary raw data. Thus, even though these items are also archived, they are not considered explicitly here. But since they are just other examples of paper and/or electronic records, the same archival methods can be used. 

Most definitions of raw data concentrate on paper and/or electronic records. A good, concise definition is found in the FIFRA Good Laboratory Practice document (1) " Raw data means... 

The types and amounts of raw data generated will be illustrated by following a planned field crop residue program from its definition (protocol) stage to the final report. The archival/documentation needs will then be similarly illustrated. 

Laboratory records will definitely be reviewed and verified by the investigator ). The records of most interest during the PAI are the ones containing the raw data used to establish both specifications, and expiry dates,... 

Final Caution. The Student t distribution is to be used when the numerical value to which it attaches is a mean of a definite number of direct observations or is a numerical result calculated from such a mean by a procedure that introduces no uncertainties comparable in magnitude to the random errors of the direct observations. This is notihe case for the specific rotation [a]j discussed above. The uncertainty contribution to the final result that is due to random errors in the raw data on optical rotations Oy is not large compared to the contributions due to the estimated uncertainties in the other variables (particularly Vand Z) that are required for calculating the final result The number of degrees of... 

If raw data are transcribed to a computer database, neither the electronically stored data nor the paper printout can substitute for the original. Information entered into the computer by direct data capture offers two options, however. The laboratory may elect to treat the electronically recorded information or a hard copy printout of the information as raw data. If the hard copy is retained, the magnetic media can be discarded or reused. If a laboratory elects to treat the magnetic media as raw data, it must retain an ability to display the data in readable form for the entire period during which that information is required to be retained. (See 58.195 for a definition of required retention periods.) If a change in computer systems would entail the loss of the... 

Raw data (i) working definition used within the laboratory and (ii) restricted access to the raw data archive and the uncorrupted restoration of the data from the archive are prime considerations. 

Three manifold flow conditions were chosen with Reynold s numbers of 1800, 6000, and 10500. The first Is definitely laminar, the latter Is turbulent and the mid range corresponds to the mid-range of the PMS counter s flow rate capabilities. The pumping speed In the PMS Instrument was chosen so that the linear velocity In the tubing and In the sampling probe were equal, resulting In Isokinetic or pseudo-isokinetic sampling conditions. The raw data are presented In Table III and the calculated count ratios In Table IV,... 

The second task involves defining the boundaries within which the model was derived and can be expected, without further motivation, to be an adequate description of the data. Within these bounds the model can replace the raw data (after all, the model is supposed to capture all salient features of the data), which will be useful when presenting the knowledge summarized by the developed model to nonpharmacometricians. The definition of these bounds can be based on the inclu-sion/exclusion criteria of the study or the realized covariate distribution. In the latter case, some of the exploratory plots from the before-analysis phase are useful. 

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