Remote 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. 

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. 

The terms electronic data capture (EDC) and remote data collection (RDC) are generally used as synonymous in describing the technology-based collection of clinical trial data from physicians participating as investigators in a clinical trial. These are web-based (online), client server (off-line), or hybrid (combined on-line/off-line) software applications. And there are implications to be considered when choosing an on-line, off-line and/or hybrid solution. However, ING Barrings differentiates RDC from EDC. 

These issues restrict the use of remote sensing devices to areas in engineering where the accuracy of the information generated is secondary to the speed of data capture. However, as research and laser development in optical technology continue, the accuracy of the commercially available non-contact scanning device is... 

The capture, processing, and retention of data should be carefully dehned and managed. The ICH GCP Guidelines, which recognize that clinical trial data can take many forms (paper, optical, electronic), indicate that the Sponsor has specific responsibihties regarding the handling of electronic data and the use of remote electronic clinical trial data systems (subsection 5.5.3). Snch responsibilities include ... 

Fume hoods are intended to be used to house activities that should not be done on an open bench because of the potential hazard which the activities represent, usually the generation of noxious fumes. The ability of fume hoods to capture and retain fumes generated within them is especially vulnerable to air movement, either due to traffic or other factors such as the location of air system ducts, windows, doors, or fans. Clearly, they should be located, as in the standard laboratory module, in a remote portion of the laboratory selected for low traffic and minimal air movement. Other fume generating apparatus, such as Kjeldahl units, should also be placed in out of the way places where errant air motion will not result in dispersion of the fumes generated into more heavily occupied areas of the room. A point that needs to be considered is the work habits of laboratory employees. Data on the possible health effects of long-term exposures to the vapors from most laboratory chemicals is relatively scant, although there are beginning to... 

Wearable device technology must have the capability to sense and capture both patient-movement data and physiological data, communicate the data to a remote center, and extract relevant inferences through data analysis. Advances in sensor technology, microelectronics, telecommunication, GPS tracking system, and data analysis are now making this possible. 

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