Data capture

Ronald D. Montgomei y Manager, Data Capture Services... 

Beverly Jendrowski, Frances L. Monroe Data Capture Specialists... 

While most of the microprocessor-based instruments are limited to a single input channel, in some cases, a second channel is incorporated in the analyzer. However, this second channel generally is limited to input from a tachometer, or a once-per-revolution input signal. This second channel cannot be used for vibration-data capture. 

There has been a push for direct data collection (DDC) as an alternative to remote data capture (RDC). In this approach most of the required clinical data are acquired directly from existing patient record systems such as MRI machines, ECG, EEG, TTM, laboratories, and other measurement equipment. This approach eliminates the need for paper transcription and reentry to another system. It promises error-free and resource-efficient data capture, which allows early locking of the database and therefore potentially earlier product launch [30]. 

Most e-Clinical software consists of integrated suites of applications that support the clinical research process, including various ways of data entry that include in-house data entry, remote data capture, batch data load, and scan forms. These suites enable customers to quickly and easily design studies, capture clinical data, and automate workflow. Some e-clinical software systems are also Internet based. 

Spink C. Electronic Data Capture (EDC) as a means for e-clinical trial success. IBM Global Services, Pharmaceutical Clinical Development 2002. http // www8.ibm.eom/services/pdf/IBM Consulting Pharmaceutical clinical development.pdf... 

Hyde AW, Amersham N. The changing face of electronic data capture from remote data entry to direct data capture. Drug Inform J 1998 32 1089-1092 0092-8615/98. 

Within the pharmaceutical industry we have progressed from the point where computers in the laboratory were rarely present or used beyond spreadsheet calculations. Now computers are ubiquitous in pharmaceutical research and development laboratories, and nearly everyone has at least one used in some way to aid in his or her role. It should come as no surprise that the development of hardware and software over the last 30 years has expanded the scope of computer use to virtually all stages of pharmaceutical research and development (data analysis, data capture, monitoring and decision making). Although there are many excellent books published that are focused on in-depth discussions of computer-aided drug design, bioinformatics, or other related individual topics, none has addressed this broader utilization of... 

Often where direct data capture systems are employed in the analytical laboratory, an additional bar code or sequential labelling system may be incorporated and could be added to this system to ensure complete union with the analytical laboratory receiving the samples. 

Automated electronic data capture systems have become increasingly important in the laboratory. They have improved the ease of manipulation and reporting of chromatography data. A regulatory requirement is that these systems must generate a permanent audit trail of the parameters employed in the collection and analysis of those data. 

The electronic data capture systems that have become commonplace in the research and analytical laboratory allow rapid and efficient acquisition, manipulation, and reporting of vast amounts of scientific data. In addition, they have provided a means to generate a permanent audit trail which describes the conditions under which a... 

Over the years, many instruments have been developed for and used in the scientific laboratory. Today, the computer is used as a major tool in the scientific laboratory for the capture, manipulation, transfer, and storage of data. Consequently, the concern for data quality has shifted from the instruments that are used in the generation of the data to these electronic systems, often neglecting the fact that the data are only as accurate as the instrument measurements. For instance, many electronic systems can be used in chromatography analysis, from the electronic log book where the test substance inventory is kept, throughout data capture in the instrument, to the digitized electronic signal that is the raw data on the computer network. For crop residue samples, the... 

In addition to observing the procedure being performed during the conduct of in-process inspections of chemistry analyses, the data collection practices and the data capture system should be inspected. The QA auditor should review the protocol and applicable SOPs for data collection practices and the procedure prior to conducting the in-process inspection. 

Migrating only the raw data - the characters, numbers, bits, and bytes - forward is not enough to ensure usability. The meta data and the context for the application or database must also be migrated forward. Meta data are the code to the machine-stored bits and bytes. Meta data are the data about the data. They describe the data in the database. The meta data documentation describes the method of data capture, the application used to access the data, security rules for the tables and columns, and other descriptive and procedural information. For derived or calculated data, the algorithm or protocol that was used must be known. The documentation then becomes something else that must be preserved. Without the meta data, the reader will only see a series of alphabetic characters. Without the entire described context associated with the data, the data have no meaning. 

Possible deviations from laboratory SOPs on data systems, lack of SOPs for the use and generation of electronic data capture... 

Assessing the resources available for method development should also be done before beginning a project. The resources available include not only HPLCs, detectors, and columns, but also tools for sample preparation, data capture and analysis software, trained analysts, and especially samples representative of the ultimate analyte matrix. Also, it should be considered whether a fast, secondary method of analysis can be used to optimize sample preparation steps. Often, a simple colorimetric or fluorimetric assay, without separation, can be used for this purpose. A preliminary estimate of the required assay throughput will help to guide selection of methods. 

Depending on the size and complexity of the clinical trial, queries sent to sites can easily number into the thousands. Because the cost of reconciling these queries quickly rises, it is important to be judicious in creating them. It is worth noting that electronic data capture (EDC) systems reduce the number of queries needed, because the entry screens are often programmed so that errant data cannot be entered. 

By personal data we mean (a) the details you provide us via our forms, e.g. your email address, all ordering and billing information, such as postal addresses and payment details, and (b) all data captured in authentication and tracking logs. 

Anaesthetized studies conducted using data capture systems to record six lead ECG (I, II, III, aV, and aVf), left ventricular pressure variables, arterial blood pressure and respiratory measurement of arterial blood flow in selected vascular beds, cardiac output and arterial blood gas measurement. ECG intervals are measured from the lead II ECG and Q-T interval can be corrected for heart rate using Bazett s, Friderecia s or Van De Water s formulas. 

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