International Journal of Medical Research & Health Sciences

  • Year: 2015
  • Volume: 4
  • Issue: 3

Optimal eCRF design, user friendly interface and proper training: quintessential for high quality data in Real World Evidence (RWE) studies

  • Author:
  • Rituraj Mohanty1,, Arun Gowda2, Anup Nair3, Anil Sharma4, Uttam Barick4
  • Total Page Count: 5
  • Page Number: 675 to 679

1M.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

2M.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

3M.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

4M.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

Abstract

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.

The aim of this article is to highlight the significance of optimal eCRF design, user friendly interface and proper training in RWE studies.

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.

Keywords

Electronic Case Report Form (eCRF), Electronic Data Capture (EDC), Patient Registry, Real World Evidence (RWE), Stakeholders