Results of a Data Imaging Pilot Project
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Drug Infurmuriun Juumal. Vol. 31. pp. 193-196. 1997 Printed in the USA. All rights reserved.
RESULTS OF A DATA IMAGING PILOT PROJECT MARIEE. LAWSON,RN, BSN, PHILIPM. BROWN,MD, JD, AND LINDASHOSTAK Pharmaceutical Research Associates, Charlottesville. Virginia
This paper presents the results of a case report form imaging pilot project. Pharmaceutical Research Associates embarked upon this project in order to provide clients with valueadded through increased efficiency and reduced costs. Although the new technology did not perj%ormas well as expected in this pilot project, data imaging will eventually play a key role in enabling contract research organizations to provide clients with valueadded. Key Words: Data imaging; Clinical trials; Contract research organizations
RESULTS OF A DATA IMAGING PILOT PROJECT
THE
OF DATA is One Of the most critical aspects of clinical trial conduct. Competition in the contract research organization (CRO) industry is continually increasing. In an attempt to enhance one’s business opportunities and create a value-added approach to client organizations, CROs are continually evaluating and evolving their existing processes to increase efficiencies. One manner in which to potentially reduce costs and increase quality is to enhance the data Remanagement process. search Associates (PRA) attempted to accomP1ish this through the Of case report form (CRF) imaging. In an attempt to institute the imaging pilot project, a multi-functional task team was assembled to represent the project*This group members Of the ’Oftware merit* information and project management, and data management groups. address: Marie E,Lawson, RN, BSN, ceutical Research Associates, 2400 Old Ivy Road, Charlottesville. VA 22903.
The intent was to involve the end users and the support staff from the outset so that the system which was developed could be both functional and supported within the current operational structure. It was also important to keep the group small, focused, and manageable. The established goals were to: Reduce the need for physical storage of CRFs, 0 Preserve the integrity of the CRFs, and 0 Increase accessibility of the CRFs to multifunctional simultaneously~ 0
Reducing CRF storage space was &sirable because office work space was at a premium. In the current system, space was being inefficiently used for storage of CRFs. Localized storage also placed restrictions on Some departments which needed to these forms on a regular basis. It was also anticipated that the imaging process would address the issues of safety and integrity of the CRFs. Theoretically, it would no longer be necessary to retrieve and use the actual CRFs in the entry, verification, clinical review, and Of the data, thus quality or reducing the need for access to the physi-
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Marie E. Lawson, Philip M. Brown, and Linda Shostak
cal or hard copy of the CRFs. CRF images would be easily and simultaneously accessed by all functional areas via the compute
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