General Introduction
REDCap (Research Electronic Data Capture) is a web-based application developed by Vanderbilt University to capture data for clinical research and create databases and projects and was first released in the year 2004. REDCap (with the latest version 11.0.3 released in May 2021) is widely used in academic research institutions with more than 2400 6400 institutional collaborators in over 115 150 countries and serves more than 590,000 2.5 million end-users and more than 450,000 1.7 million ongoing research studies on this platform (updated on 11th Jan 202218th April 2023).
Reasons to use REDCap
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Secure – Full user authentication (log-on/password), customizable user rights restrictions, real-time data validation, centralized & secure data storage, data de-identification options, and a full audit trail. Inbuilt, it is Health Insurance Portability and Accountability Act (HIPAA)–compliant, highly secure, and intuitive to use.
Web-based – Enter data or build your database from anywhere in the world over a secure web connection with authentication and data logging.
Fast – Quick project start-up. Clinical report forms can be implemented without the need for a programmer. Concept to the production-level database is possible in less than one day.
Easy – Intuitive user interface and workflow, readily available online training materials
Fully customizable – In total control of shaping your database.
Autonomous utilization – Research groups have complete autonomy and control to add new users and set several levels of specific user rights.
Data export – Seamless data downloads to common statistical packages (including SPSS, SAS, Stata, and to the .csv (comma separated values) format, the most common import and export format for spreadsheets and databases.
Data import – Data import capability through Microsoft Excel
Advanced features – File uploading, auto–validation, branching logic, calculated fields, signature, Dynamic Query (SQL), and more!
Offers unique features that can be used to conduct rigorous RCTs.
Project workflow in REDCap:
Diagrammatic Representation of Project workflow:
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Steps to Create New Project
Study Design: Before beginning a REDCap project, formulate a general study design. Ex: Who or what are you planning to study? What kind of data are you measuring? Will your study be cross-sectional or longitudinal? Have you discussed your study design with a statistician?
IRB Approval: If a study is a research project with human subjects or involving Protected Health Information (PHI), it is likely to need the documented approval of the Institutional Review Board. All research projects with PHI data should go through IRB. On the other hand, projects focused on Quality will not require IRB approval but are strongly advised to contact IRB and get confirmation.
Request New Project: Send an email to the institution which holds the REDCap server to request a new REDCap account.
Design Data Forms: In order to effectively collect and order study data, first design the data collection forms to do so. This step is the highlight feature of REDCap: immensely customizable, expandable, fluid data forms.
Testing: Test data collection forms to verify all needed data are collected correctly before committing to production mode. If possible, designate one person to perform the build and another to perform the testing.
Deployment: Once the study enters Production Mode, need to enter, review, and analyze real data. In Production Mode, it is more difficult and risky to make major changes to your data entry forms, which is why thorough testing is strongly encouraged.
Draft Mode: If enter to production and find that project does need to modify an element of data entry forms, need to enter Draft Mode and submit changes to be approved by a REDCap Administrator. Data activities can continue during this mode.
Inactive Mode: No data entry or update may take place in this mode, although may view and analyze data.
Archived Mode: If completed data analysis, moved the project to indefinite hiatus, or simply decided not to use it, may move the project to archived status as an alternative to full deletion. Archived projects incur fees as well which depend on institutions' rules. Can un-archive project at any time.
Delete Project: After completion of the project, it is highly recommended to delete the project. It is recommended to download the project data dictionary along with its data and save it safely in safe places like Box or OneDrive. After this step, delete the project from REDCap. In case if need to restore the project at a later point in time, can import the data dictionary with or without data.
REDCap Important Terms
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Arms: groups of events. You may want to employ multiple arms when using different treatment groups (control, experimental) or conducting a multi-site study, for instance.
Branching Logic: may be employed when fields/questions need to be hidden for data entry under certain conditions. For instance, you may want to hide the question “How many hours per week do you watch TV?” until a “Yes” answer is checked for a previous question, “Do you watch TV?”
Data Access Groups: restrict viewing of data within a database, for instance in a double-blind or multi-site study.
Data Collection Instrument: a form created to capture data. This term is essentially interchangeable with “data entry form.”
Data Dictionary: a specifically formatted .csv spreadsheet containing the metadata used to construct data collection instruments and fields.
“Development” vs. “Production” Modes: study status modes. In Development Mode, you are still working through the design of your data forms and testing them with mock data; you may make any changes to the forms at any time. In Production Mode, you have deployed your forms and you are collecting real data; changes to your forms are more difficult to implement once you have launched into Production Mode.
Event: used in longitudinal designs. An event is a scheduled (or unscheduled) occurrence during which data is captured using your REDCap data instruments (forms).
Field: a singular data entry, such as age or height.
Form Status: status of the record’s data form completeness, denoted with a color; red – incomplete; yellow – unverified; green – complete.
Logging: the audit trail of modification occurrences in the project.
Record: the set of information for a unique participant or subject. Each record is composed of a number of fields (pieces of data), which can be spread across multiple forms (instruments) per record.
Record ID: a unique key that can identify each record in the database.
User Rights: the customized privileges that research team members have in terms of data form modification, data entry, and data access. P.I.s may create “Roles” for groups of team members to ensure consistency in specified user rights.
Variable Name: the name of the variable that is stored in the REDCap database (not visible during data entry).
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