Electronic data capture

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. 

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... 

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

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. 

In the future, data will increasingly be captured electronically. Image processing and developments in optical character recognition are already proving useful. Electronic data capture (using fax or pen-based methods) is used to collect data in some clinical trials. 

It is helpful to utilize electronic data capture when possible. Computer-assisted data entry, or electronic data capture, at the time of the subject s clinic visit or procedure makes the data entry process quicker and less susceptible to error. It also offers the chance to monitor data collection in a timely manner as the clinical trial progresses, which facilitates the opportunity to detect trends toward poor quality or unexpected data that may be the result of the investigator site failing to adhere to the protocol. Early detection and correction are much preferable to the alternative. 

Retention requirements for electronic records are discussed in Chapter 12. It is important to remember that electronic data capture can undermine data integrity. Image capture techniques may reproduce an original record very accurately, but if the original has insufficient dots per inch for clear reading, then the reproduction may not be usable. Electronic records are often not nearly as rugged and durable as their paper counterparts. The following factors may affect their life expectancy ... 

What type of measurement system will you use to gauge whether the process output is within spec limits Measurement systems can be as simple as a stopwatch or as complex as an electronic data-capture process. Keep in mind that the simplest solution is usually the best the goal is to provide an exemplary product or service, not to create elaborate measurements that delay delivery. 

The CRF is the document used to record all of the protocol-specified data to describe individual subject results. Many sponsors use standard modules to prepare the CRF and are increasingly using electronic data capture technology. 

Although superficially attractive, there has not been the widespread take up of technology that many have predicted for the past 15 years. The use of electronic data capture (EDC) remains in its infancy. There are many suppliers, and most companies have conducted studies with EDC. However, the difficulties in training investigators and ensuring consistent technological support 24 hours a day, 365 days a year, in many different countries remain formidable. Ss internet access improves, electronic diaries may become more widely use for some particular types of studies, such as asthma and diabetes, where patients are accustomed to keeping diaries in any event. 

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. 

The patient calls family physician s office and is instructed to come in that afternoon. She arrives at physician s office, activates personal health card (e.g., a smart card is activated by the patient s thumb print), hands it over to the receptionist the RFID microchip in the health card is activated by the reader at the physician s office and the electronic patient record is open. The patient is shown to the examination room a nurse takes vital signs captured via an electronic data capture system including voice dictation. The family physician sees her and orders an ECG (electrocardiogram) test. The patient sees the receptionist the receptionist finds the laboratories nearest to her home gives her the addresses of two nearest laboratories. The patient goes to the nearest diagnostic laboratory. The RFID microchip in the health card is activated by the reader at the laboratory ECG (electrocardiogram) is performed, blood is drawn (test location records ECG results, notifies physician of ECG completion), and the specimen is sent to a second location. The patient waits at home for a call from her family physician. The blood sample arrives at the second... 

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