Use of Research Electronic Data Capture (REDCap) in different phases of a COVID-19 randomized controlled trial: A practical example

Abstract Background: Randomized controlled trials (RCT) are considered the ideal design for evaluating the efficacy of interventions. However, conducting a successful RCT has technological and logistical challenges. Defects in randomization processes (e.g., allocation sequence concealment) and flawed masking could bias an RCT’s findings. Moreover, investigators need to address other logistics common to all study designs, such as study invitations, eligibility screening, consenting procedure, and data confidentiality protocols. Research Electronic Data Capture (REDCap) is a secure, browser-based web application widely used by researchers for survey data collection. REDCap offers unique features that can be used to conduct rigorous RCTs.Methods: In September and November 2020, we conducted a parallel group RCT among Indiana University Bloomington (IUB) undergraduate students regarding their seropositivity for Coronavirus Disease 2019 (COVID-19) antibodies. In the current report, we discuss how we used REDCap to conduct the different components of this RCT. We further share XML REDCap files and instructional videos that investigators can use when designing and conducting their RCTs.Results and Conclusions: We report on the different features that REDCap offers to complete various parts of a large RCT, including sending study invitations and recruitment, eligibility screening, consenting procedures, lab visit appointment and reminders, data collection and confidentiality, randomization, blinding of treatment arm assignment, returning test results, and follow-up surveys. REDCap offers powerful tools for longitudinal data collection and conduct of rigorous and successful RCTs.