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Electronic patient diaries are available in two primary formats. Patients can record information daily on a variety of small electronic devices. Data recorded on these devices can be read remotely from the clinic site and/or downloaded from the device when the patient visits the clinic. Alternatively, patients can use a telephone keypad to answer diary questions asked by an automated telephone system. Patients can call in to the system or be called. Daily harvesting and review of diary data provides a timely means of monitoring the progress of the study. |
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Databases containing information about quality of life and cost of care are sometimes assembled from data obtained outside the study clinic. Quality of life data are often collected daily and can be part of a daily diary that could be transmitted via an electronic device. Cost of care data may need to be collected from many different sources. Hospitals, clinics, and pharmacies usually have an electronic record of their charges and, in some studies managed by CROs, cost data have been transferred to the study database electronically. |
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Several CROs and sponsors have developed information systems that will allow study databases to be warehoused in a read-only environment for access by both internal and external users. Query tools can be made available through a menu when the data are viewed or data can be downloaded to local environments where existing, sometimes unique, tools are available for special purpose reviews. The data can be refreshed as often as new data are processed. Since data are warehoused, processing of new data and review of current data can proceed independently and unencumbered by read-only users (Figure 2). |
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D. International Databases: Integration of Data |
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Many CROs with an international presence are positioned to support sponsors with multipurpose international databases. An international database for a product could be used to support regulatory filings in different formats in different countries. The key to providing this flexibility is the coordination of the types of data that will be collected in the international studies. If the primary outcome and safety endpoints are all collected using the same or essentially similar definitions, then the success of the data integration is made much more likely. The same variable collected in multiple studies will be assigned a unique name in the integrated database. Laboratory values reported in different units will be converted or normalized according to their magnitude relative to their study-site-specific normal ranges. Safety, therapy, and other data that need to be dictionary coded, will be coded using the same dictionaries. |
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