Developing an Electronic Data Capture System for Study Enrollment and Surveys using REDCapCloud.com within the US Air Force

Introduction: REDCapCloud.com is a data science platform designed for regulatory-grade usage which affords virtual consenting and electronic data capture utilizing branching logic to create customizable study workflow processes. REDCapCloud.com was selected to facilitate enrollment and data collection for a large-scale genomics study on resilience-related risk/protective factors in military personnel. Objective: Utilizing an Institutional Review Board (IRB)-approved protocol for our proof-of-concept scenario, we created a REDCapCloud.com-designed study to simulate and test the ability to: 1) Identify participants which meet the study's inclusion criteria; 2) Allow study participants to schedule a virtual consent call and sign consent and HIPPA documents; 3) Email consented study participants their signed electronic consent and HIPPA forms; 4) Deliver 15 web-based surveys and collect responses, and 5) Request their mailing address if study participants consented to provide a saliva sample for DNA analysis. Methods: We performed a hybrid moderated and unmoderated workflow study to assess the platform’s capability to pre-screen individuals, conduct virtual informed consent, and collect survey data. Results: REDCapCloud.com correctly screened mock study participants meeting inclusion criteria, successfully scheduled virtual consent, and effectively collected consent/HIPAA signatures and emailed participants password-protected forms. Programmed branching logic successfully triggered the sequential delivery of 15 instruments for data capture and collected shipping addresses for DNA analysis. Conclusion: REDCapCloud.com is a highly functional platform capable of expediting study screening, enrollment, virtual consent, and data capture in a graphical user interface for data entry with a validation component to check user data and a de-identification component to make data less identifiable.