Increase your grant’s “Innovation” and “Approach” scores by including Studytrax as a proven well-established data collection tool that provides the following benefitsdesigned to: 1) engages engage and retains retain subjects through using a dynamic, interactive portal, and 2) integrates integrate the analytical / dissemination phase directly within the application (which also eliminates reporting headaches such as progress reports).
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The purpose of the study database is to track subject participant enrollment, capture data elements in a series of short, well-designed forms all available on-line via a secure web portal, and facilitate the transfer of data into statistical packages for analysis. The database application, called Studytrax, uses MS SQL Server as the back end relational database. The program can support one or more research studies, is presently being used at dozens of major academic research centers to support numerous NIH funded projects and is available commercially ( http://www.studytrax.com/ ). The HIPAA privacy rules and HIPAA security rules mandate that covered entities have in place appropriate policies and procedures to protect the confidentiality and security of protected health information. In compliance with these regulations, the database security features of Studytrax target multiple levels including the data element (e.g., restricted access to fields), user (e.g., password authentication access), application (e.g., role-based access to features, access audit trails), and hosting services (e.g., firewall, secure sockets layer). Taken together, these features ensure access control, audit control, data integrity, user authentication, and transmission security. The research project(s) will be set up in Studytrax to ensure exported datasets are de-identified as defined in the HIPAA privacy regulation [45 C.F.R. §164.514 (b)(2)]. A 21 CFR Part 11 compliance document is available upon request from the creators of the software, a company called ScienceTRAX, LLC.
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Historically, electronic data capture (EDC) systems have focused on accurate execution of the research protocol and data storage. As a result, participants interacting with these systems experience nothing more than the burden of data entry. Leveraging principles from the Patient Health Engagement Model (PHE-model; Barello et al, 2015; Graffigna et al. 2016; Graffigna et al. 2017), Studytrax is an innovative EDC system with an internet-based portal that is designed to engage and retain subjects participants in the research process. The core feature set includes the following:
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Participants will enroll themselves via an email or website containing a “Participate“ link/button. When clicked, forms containing screening questions without identifying fields will be presented for completion. Upon save, an automated screening ID will be generated and data from the screening form will be transferred via an encrypted connection so as to ensure screening information can NOT be tracked back to participants. Those that pass screening criteria will be asked for participation consent. Those choosing to give consent will have an option to create an account for the study web portal which communicates with Studytrax servers using Restful web services over an encrypted Secure Sockets Layer (SSL).
(C) If only staff will create accounts:
Research staff will create and manage participants accounts for the study portal. Participants will validate their accounts and have control over their account information (e.g., password). The study portal communicates with Studytrax servers using Restful web services over an encrypted Secure Sockets Layer (SSL)
As Applicable, add the text below for Reward Points:
The number of reward points earned for completing each form and/or study visit will be assigned in Studytrax. The study portal communicates with the Studytrax servers using Restful web services over an encrypted Secure Sockets Layer (SSL). Participants exchange reward points for gift cards in the study portal using a Studytrax partner's Service (RaaS) Application Programming Interface (API). All communication with gift card partners is over SSL using HTTP Basic Authentication. All transactions involving reward points and gift cards are logged both in Studytrax and the gift card partner’s site.
Application Hosting and Security Description
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