Boilerplate Language for Including REDCap in Your Protocol
The protocol should describe how the study team will using the REDCap software. Some examples of the ways you might use REDCap include: data storage, data entry by study staff, survey distribution via email or text messaging, direct collection from participants and/or eConsent.
The protocol should explicitly state that OHSU’s instance of REDCap will be used (rather than a REDCap version at another institution). If the study is multi-site the data should be stored at the Central or Data Coordinating Center.
Example Boilerplate & Technical Information
Below is some example boilerplate and technical information that may be useful in the data security portion of a protocol. Note this language is not required.
Data for this project will be stored in OCTRI's installation of REDCap, a highly secure and robust web-based research data collection and management system.
Features of REDCap that protect participants' privacy and data security include:
- Physical Security: OCTRI's REDCap software is housed on servers located in ITG's Advanced Computing Center providing locked physical security
- Electronic Security: The REDCap servers are housed behind both the OHSU firewall and a second ACC firewall. All transmissions of data from the application are encrypted over HTTPS with the industry standard TLS 1.2/1.3 protocol (AES 256-bit encryption).
- Controlled User Access: REDCap employs a robust multi-level security system that enables researchers to easily implement "minimum necessary" data access for their research staff, including specification of data fields that are identifiers. This feature includes “single click” ability to provide completely deidentified (removing all identified data fields and shifting dates) for analysis or other purposes. User activities are logged to enable auditing of all data access. Access is integrated with OHSU's network such that users who are also OHSU employees are authenticated against their OHSU network credentials.
- Data Integrity: REDCap is jointly managed in accordance with OHSU Information Security Directives by ACC staff and members of OCTRI's Biomedical Informatics Program, ensuring fidelity of database configuration and back-ups. User activities are logged to enable auditing of all data changes.
eConsent using REDCap
If the project has eConsent in REDCap please refer the wiki page: 2 - Regulatory Considerations & Preparing to Use REDCap (e-consent).
Repositories with More than One IRB
Repositories in REDCap that are associated with multiple IRB's will need to contact email@example.com for a consultation. By default, REDCap is designed for capturing data for a single protocol. The purpose of the consultation is to discuss the projects needs and which features may be utilized to accommodate data associated with more than one protocol, as well as identify any challenges.
Transferring a REDCap Project between Protocols
Review the following information to re-purpose a project for a different protocol than the one it was requested and approved for.
REDCap Project in Production
To re-purpose a project that is in production (and collecting real data) for a different protocol than the one it was approved for:
- Make a copy of the project (without data).
- Complete OCTRI's Resource Request form to submit the additional documentation about the project request.
- To transfer data from the original project to the new project:
- Export data from the original project.
- Ensure the data you have exported and want to transfer to the new project are a part of your IRB approved protocol.
- Once the new project is moved to production, import the data.
REDCap Project in Development
To re-purpose a project in development for a different protocol than the one it was requested for, please contact firstname.lastname@example.org. We will need to make a determination about which of the following options apply to moving forward:
- REDCap Project Only Needed for New Protocol and Not Needed for Original Protocol it was Requested for:
- REDCap Project Needed for both the Protocol it was Requested for and a New Protocol
To re-purpose a project that has been marked as completed and taken offline for a new protocol, contact email@example.com. If there are plans for including this data in a repository or new REDCap project, or using this project as a template for a repository or other type of REDCap project, please let us know as soon as possible so we can coordinate with you on the next steps.