OPTIMAL eCRF DESIGN, USER FRIENDLY INTERFACE AND PROPER TRAINING: QUINTESSENTIAL FOR HIGH QUALITY DATA IN REAL WORLD EVIDENCE (RWE) STUDIES
Journal Title: International Journal of Medical Research & Health Sciences (IJMRHS) - Year 2015, Vol 4, Issue 3
Abstract
Background: The success of a Real World Evidence (RWE) study lies in collecting and processing high quality data. Data in RWE study can be collected in a paper format as in a Case Report Form (CRF) or electronically in the format of electronic Case Report Form (eCRF). For a multi-country/multi-centric study, eCRF can offer advantages over the conventional paper CRF for collection of data. An approach which is a combination of optimal eCRF design, user friendly interface and proper training can facilitate in collection of high quality data. Aim: The aim of this article is to highlight the significance of optimal eCRF design, user friendly interface and proper training in RWE studies. Conclusion: Implementation of EDC system with eCRF can be advantageous for a multi-country/multi-centric RWE studies, as it facilities real time monitoring, which can yield adequate data of high quality. Implementation of eCRF can be cost and time effective.
Authors and Affiliations
RiturajMohanty| M.B.B.S, Associate Project Manager, Focus scientific research center (FSRC), part of phamax AG, #19 KMJ Ascend, 17th C Main, 1st Cross, 5th Block, Koramangala, Bengaluru, Karnataka, India – 560095, Corresponding author email: rituraj.mohanty@fs-researchcenter.com , ArunGowda| M.B.B.S, Director, Focus scientific research center (FSRC), part of phamax AG, #19 KMJ Ascend, 17th C Main, 1st Cross, 5th Block, Koramangala, Bengaluru, Karnataka, India – 560095, AnupNair| M.Sc, Clinical Research Associate, Focus scientific research center (FSRC), part of phamax AG, #19 KMJ Ascend, 17th C Main, 1st Cross, 5th Block, Koramangala, Bengaluru, Karnataka, India – 560095, AnilSharma| M.Sc, Clinical Research Consultant, Focus scientific research center (FSRC), part of phamax AG, #19 KMJ Ascend, 17th C Main, 1st Cross, 5th Block, Koramangala, Bengaluru, Karnataka, India – 560095, UttamBarick| M.Sc, Clinical Research Consultant, Focus scientific research center (FSRC), part of phamax AG, #19 KMJ Ascend, 17th C Main, 1st Cross, 5th Block, Koramangala, Bengaluru, Karnataka, India – 560095
Keywords
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- DOI 10.5958/2319 - 5886.2015.00129.0
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