Boilerplate language for REDCap Grants
The Ohio State University (OSU) Research Informatics Services (RIS) core, housed within the Department of Biomedical Informatics (BMI) with major support from the Center for Clinical and Translational Science (CCTS), will be utilized as a central provider for this project’s Electronic Data Capture (EDC) support. The OSU RIS core utilizes REDCap (Research Electronic Data Capture) as its primary EDC platform which will be adopted for this project. REDCap has been developed by Vanderbilt University, with collaboration from a consortium of institutional partners (including OSU), as a software toolset and workflow methodology for electronic collection and management of research and clinical trial data. The REDCap platform is a secure, web-based application flexible enough to be used for a variety of types of research, provides an intuitive interface for users to enter data, and enforces real time validation rules (with automated data type and range checks) at the time of entry. This platform provides an intuitive data manipulation interface, custom reporting capabilities, audit trail functionality, and real-time data monitoring/querying of participant records. REDCap has multiple data export options to common statistical packages (SPSS, SAS, Stata, R/S-Plus).
REDCap data collection projects rely on a study-specific data dictionary defined in an iterative self-documenting process .The project specific data dictionary is defined by the research team with assistance from RIS staff. As part of the data dictionary development process, individual fields can be denoted as identifiers. When exporting a de-identified dataset, these variables are omitted. Additionally, the data export tool allows for the shifting/removal of dates. REDCap supports electronic signatures by positively identifying the user through a unique username and password combination. The provisioning of accounts for system authentication is integrated with the OSU Wexner Medical Center (OSUWMC) LDAP authentication service for studies containing protected health information (PHI) and is secured behind the OSUWMC firewall. The provisioning of authorization (e.g. access to specific projects, user rights within the project, etc.) for all projects is managed by RIS staff in conjunction with the project Primary Investigator (PI).
Based on the EDC requirements outlined for this project the RIS staff have recommended REDCap as an appropriate and desirable tool. Members of the RIS team will facilitate the creation and support of a project-specific database utilizing the REDCap data collection platform. OSU, through the CCTS, is an institutional partner of the REDCap consortium, which will allow the project to access and utilize this software application via the OSU hosted installation. The informatics support for the project will include access to, configuration of, and support for the REDCap web-based research data collection platform. Support will also be available for REDCap data collection instrument design as well as data Extract/Transform/Load (ETL) processes on an as requested basis. In addition, RIS maintains expertise in a variety of informatics domains including software design and engineering, data integration, and data security. If unanticipated informatics needs arise during project execution RIS can be utilized as a support resource. Based on the scope of work for this project it is anticipated that these services will require approximately $xx,xxx of informatics consultation/implementation effort over the course of the project. The overall expertise and technologies offered by the RIS Core are ideally suited to collaboratively support this projects needs.
Boilerplate language for REDCap Buck-IRB Applications
This study will utilize REDCap (Research Electronic Data Capture), a software toolset and workflow methodology for electronic collection and management of clinical and research data, to collect and store data. The Ohio State Center for Clinical and Translational Science (CCTS) Research Informatics Services will be used as a central location for data processing and management. REDCap provides a secure, web-based application that provides an intuitive data manipulation interface, custom reporting capabilities, audit trail functionality, real-time data monitoring/querying of participant records, and variations of data exporting/importing. REDCap is hosted by OSUWMC IT in the Ackerman Datacenter (640 Ackerman Road; Room 345)
(Only use if the study requires a PHI database)
REDCap instance is located on an internal OSUWMC network. Remote access to this network can be obtained over an encrypted VPN tunnel (AnyConnect). This VPN uses Protocol: DTLS and Cipher: RSA_AES_128_SHA1. Background checks are performed on all staff that are on the network or obtaining VPN access.
(Only use if the study requires a Non-PHI Database)
REDCap instance is located outside of the OSUWMC network. Non-PHI Redcap is accessible from any internet connection. No encrypted VPN tunnel is required.
REDCap supports electronic signatures by positively identifying the user through a unique username and password combination. The provisioning of accounts and user access to specific database(s) is integrated with the OSUWMC LDAP authentication service for studies containing protected health information (PHI), the provisioning of access and specific user rights for all studies and review of content are managed by CCTS staff.
Boilerplate language for Human Subjects Research Studies Using Electronic Consent in REDCap
The participant consent encounter will be conducted using a REDCap-based electronic consent form. The consent form has been developed in REDCap, a secure, web-based, HIPAA-compliant, data collection platform with a user management system allowing project owners to grant and control varying levels of access to data collection instruments and data (e.g. read only, de-identified-only data views) for other users. Potential participants will participate in the consent process by (select method):
- Being approached in-person at The Ohio State University and accessing the REDCap survey via iPad or other portable electronic device and/or
- Self-initiated access of consent forms on personal portable electronic devices using posted QR codes or web-links on study posters, brochures, or websites. Self-initiated accessing of consent forms may occur at The Ohio State University campus or at home.
During the in-person consent process, consent will be obtained by a member of the study team.
For self-initiated consent, contact information will be provided (email and phone) for prospective participants to contact a member of the study team with questions, prior to consent.
Participant signatures will be obtained using a (select method: typed name and electronic signature via mouse). Upon completion of the consent encounter, participants will be provided with a copy of the consent document by (select method: printing a pdf copy of the consent form, providing participants with a business card/brochure with the web link to the appropriate version of the consent, provide home address for mailing of a hard copy of the consent).