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ticularly through preferred supplier and strategic alliance relationships, sponsors and CROs are capitalizing on shared capabilities to enhance these technologies [13]. |
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Over a decade ago, desktop computers were installed at clinical sites to be used as study management and data collection devices. That study sites were in the best position to monitor and transfer to an electronic format the data from their patients seemed clearly logical. The clinical site computers were linked to a central study computer for harvesting, reviewing, and integrating data. Clinical monitors were to review electronic data harvested from the study sites and to use site visits to verify source documents, query questionable data entries, and ensure compliance with regulatory requirements. This general approach to data collection and monitoring was named remote data entry (RDE). |
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The concept of RDE is sound but how and when to use it was initially not well understood. For each success there were failures. Some of the failures were so major that RDE is no longer used by many sponsors. Yet, the appeal of the idea that data can best be reviewed and validated at the source of collection and near the time of collection has, along with the availability of new technology, spawned new systems to manage data that are being collected from many distributed sites. |
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Powerful notebook computers, some with touch screens, are used as combination data collection instruments and data entry/validation processors. As data are entered at the site, the software checks the logic and consistency of the entry and reports the results of the electronic review almost immediately. The site can review the electronically checked data and make edits as appropriate. An electronic audit trail of all edits is maintained. Entered data and audit logs can be harvested remotely by the monitoring site for review and for integration with other study data. If there is a requirement to maintain a paper case-report form, a copy of the electronic form can be printed and filed. |
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An increasing number of CROs and sponsors are managing clinical trials by relying on images of case-report forms that have been transmitted from remote study sites to a central location. The images can be reviewed on a computer monitor and queries/comments can be added to the image. The annotated image can be transmitted back to the study site for review and clarification. This cycle can continue until the information sent by the site satisfies the requirements of a visual review. The initial, intermediate, and final transmitted images can be stored and are available for cataloging, linking to the clinical database, and further review. In addition, the clean and complete case report forms are available to be entered into an electronic database by a combination of traditional key data entry and electronic character recognition. As the data are entered into the clinical database and once entry is complete, they are subjected to electronic verification (logic and consistency checks). The |
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