Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial.

ABSTRACT:

Background

Regulations, study design complexity and amounts of collected and shared data in clinical trials render efficient data handling procedures inevitable. Recent research suggests that electronic data capture can be key in this context but evidence is insufficient. This randomized controlled parallel group study tested the hypothesis that time efficiency is superior when electronic (eCRF) instead of paper case report forms (pCRF) are used for data collection. We additionally investigated predictors of time saving effects and data integrity.

Methods

This study was conducted on top of a clinical weight loss trial performed at a clinical research facility over six months. All study nurses and patients participating in the clinical trial were eligible to participate and r

SUBMITTER: Fleischmann R 

PROVIDER: S-EPMC5709849 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature