{"id":885,"date":"2024-10-21T09:00:00","date_gmt":"2024-10-21T09:00:00","guid":{"rendered":"https:\/\/www.socra.org\/blog\/?p=885"},"modified":"2024-04-18T16:24:55","modified_gmt":"2024-04-18T16:24:55","slug":"redcap-project-building-a-tool-for-the-distribution-and-management-of-research-surveys-and-databases","status":"publish","type":"post","link":"https:\/\/www.socra.org\/blog\/redcap-project-building-a-tool-for-the-distribution-and-management-of-research-surveys-and-databases\/","title":{"rendered":"REDCap Project Building: A Tool for the Distribution and Management of Research Surveys and Databases"},"content":{"rendered":"\n
\"Picture<\/figure>
\n

Emily Navarreto, BS<\/p>\n\n\n\n

Clinical Research Coordinator<\/p>\n\n\n\n

Thomas Jefferson University<\/p>\n<\/div><\/div>\n\n\n\n

<\/p>\n\n\n\n

Abstract: <\/strong>REDCap is a secure web application that was designed for building and managing online surveys and databases. This article focuses on the many benefits of REDCap for collecting research data. Topics covered include how to build a project, survey distribution, exporting data securely, and analyzing results. The variety of projects that can be built on the platform and how to effectively manage both individual and mass data collection are highlighted.<\/em><\/p>\n\n\n\n\n\n\n\n

What is REDCap?<\/h5>\n\n\n\n

REDCap stands for Research Electronic Data Capture. Vanderbilt University created REDCap in 2004 for their own data entry and collection forms for clinical research. They found that REDCap was a great tool for collecting data and, in 2006, Vanderbilt University expanded REDCap into the REDCap Consortium.<\/p>\n\n\n\n

Through the REDCap Consortium, REDCap became available to other institutions. Currently, over 6,000 institutions in 145 countries utilize REDCap. Millions of individuals use REDCap and tens of thousands of articles have been written using data from REDCap.<\/p>\n\n\n\n

REDCap is a secure web-based application that is accessible on any web browser. It is highly accessible and does not require a virtual private network. Designed for secure data collection, REDCap is compliant with the Title 21 of the Code of Federal Regulations Part 11 Electronic Records; Electronic Signatures, the Federal Information Security Modernization Act, the General Data Protection Regulation, and the Health Insurance Portability and Accountability Act.<\/p>\n\n\n\n

Types of Projects<\/h5>\n\n\n\n

Several types of projects can be developed in REDCap. A traditional project is a blank slate. It can be used in a variety of ways, such as a data entry form. For example, a traditional project can be used to record subjects\u2019 vital signs or demographic data. A virtual informed consent form, with secure signature lines, is another example of a traditional project.<\/p>\n\n\n\n

A single survey project is used to develop and distribute a single survey to subjects. This can be a simple questionnaire that the research team has developed or a validated survey instrument, which can be downloaded from the REDCap library. Researchers can send a single survey to people using a public or private survey link.<\/p>\n\n\n\n

Other types of projects are longitudinal projects and longitudinal projects with scheduling. A longitudinal project is used for studies that are more abstract and do not have specific time points. For example, an intervention may be have the option of being used for three or six months. A longitudinal project allows for more flexibility when the surveys are sent out.<\/p>\n\n\n\n

For studies with concrete, defined time points, researchers can use a longitudinal project with scheduling. Surveys in a longitudinal project with scheduling are sent based on time points in the protocol and can be scheduled in advance. Longitudinal projects with scheduling are helpful for multi-site studies where surveys are sent out regularly.<\/p>\n\n\n\n

While REDCap was developed for clinical research, it can also be used for operational projects related to clinical research such as quality improvement, workflow, education, and administrative projects. REDCap can also be used for research outside of the clinical spectrum due to its flexible data collection features. An example of an operational project would be, creating a quality improvement plan to make study visits more efficient with features that would allow data entry to track changes over time.<\/p>\n\n\n\n

Another example of an operational project related to clinical research that could be created in REDCap is to create a timeline to track the institutional review board process (review dates, submissions, approvals, and so forth). Documents can be uploaded in REDCap. Any operational project can be built in REDCap.<\/p>\n\n\n\n

How to Build a Project<\/h5>\n\n\n\n

After creating an account in REDCap, the user will have the option to, \u201cCreate a new REDCap project.\u201d This screen includes fields for the project title, owner, purpose, and notes. If the project is for a study, the project title would likely be the study name. If the project is operational, the project title would be related to the topic.<\/p>\n\n\n\n

Whoever creates the project is typically the project owner. The owner can be edited at any time. Often, an investigator is listed as the project owner.<\/p>\n\n\n\n

There are several options to choose for the purpose of a REDCap project, which include: research, operational, practice, and other. The functions within REDCap somewhat differ depending on the purpose that is chosen. The research and operational purposes have been discussed. Practice projects can be used, for example, to build projects that will be utilized in the future or to assist new users in learning how to use REDCap. If an individual creates a practice project, it can be changed later to a research or operational project.<\/p>\n\n\n\n

There are three project creation options:<\/p>\n\n\n\n

    \n
  • Empty project (blank slate)<\/li>\n\n\n\n
  • Upload a REDCap project via XML file (CDISC CDM format)<\/li>\n\n\n\n
  • Use a template (choose one below).<\/li>\n<\/ul>\n\n\n\n

    If clinical research professionals choose a template, options may include single surveys, classic databases, and e-consent (institution specific).<\/p>\n\n\n\n

    Once the project has been created, the dashboard will have a toolbar on the left hand side of the screen. The toolbar will be on every project page in REDCap. The toolbar includes \u201cMy Projects,\u201d \u201cREDCap messages,\u201d and then three sections: \u201cProject Home and Design,\u201d \u201cData Collection,\u201d and \u201cApplications.\u201d<\/p>\n\n\n\n

    Under \u201cMy Projects,\u201d clinical research professionals will be able to see any projects that they have already created and projects that have been shared with them. \u201cREDCap messages\u201d enables clinical research professionals to ask REDCap information technology questions. Clinical research professionals build the project under \u201cProject Home and Design\u201d tab in \u201cDesigner.\u201d \u201cProject Setup,\u201d under \u201cProject Home and Design,\u201d is on the right-hand side of the screen. This has more functions to build the project, with sections for: \u201cMain project settings,\u201d \u201cDesign your data collection instruments & enable your surveys,\u201d and \u201cDefine your events and designate instruments for them.\u201d After designing the project, it goes into production and can be used for secure data collection.<\/p>\n\n\n\n

    The \u201cData Collection\u201d tab has options such as \u201cSurvey Distribution Tools,\u201d \u201cRecords Status Dashboard,\u201d and \u201cAdd\/Edit Records.\u201d \u201cRecords Status Dashboard\u201d contains all of the data that has been collected. \u201cSurvey Distribution Tools\u201d is where surveys can be distributed to subjects. The \u201cApplications\u201d tab has many functions including adding new users and exporting data.<\/p>\n\n\n\n

    Under \u201cMain project settings\u201d in \u201cProject setup,\u201d clinical research professionals can modify the purpose and title of the project at any time. This is also where they can choose \u201cUse surveys in this project\u201d or \u201cUse longitudinal data collection with defined events.\u201d Instruments can also be designated for the events. An instrument can be designated for each event and the surveys can be sent out at that time or scheduled.<\/p>\n\n\n\n

    \u201cDesigner\u201d allows clinical research professionals to create a data entry form from scratch or choose a template.<\/p>\n\n\n\n

    Several options for fields include:<\/p>\n\n\n\n

      \n
    • Text Box<\/li>\n\n\n\n
    • Multiple choice<\/li>\n\n\n\n
    • Checkboxes<\/li>\n\n\n\n
    • Yes\/No<\/li>\n\n\n\n
    • True\/False<\/li>\n\n\n\n
    • Calculated Field<\/li>\n<\/ul>\n\n\n\n

      There are also options to include signatures for e-consents and to upload files such as videos or photos. The top of each field on the data entry form has a pencil for editing and an \u201cx\u201d for deleting a field. Fields can also be copied and moved around. The stop sign marks the completion of the data entry form based on the respondent\u2019s answers.<\/p>\n\n\n\n

      Once data is entered, it is stored in the \u201cRecords Status Dashboard,\u201d which can be accessed in the toolbar. Individuals can use the dashboard to view their own data entries, individual subjects or all subjects in a study. In the individual subject view, you will see each data collection instrument, the amount of data that has been collected, whether the instruments have been completed, and events such as the screening process, study visits, and doses of the study drug. The dashboard is color coded for easy understanding of the status:<\/p>\n\n\n\n

        \n
      • \u201cIncomplete: Red<\/li>\n\n\n\n
      • Unverified: Yellow<\/li>\n\n\n\n
      • Complete: Green<\/li>\n\n\n\n
      • Incomplete, no data saved: Gray<\/li>\n\n\n\n
      • Partial survey response: Yellow<\/li>\n\n\n\n
      • Completed survey response: Green.<\/li>\n<\/ul>\n\n\n\n

        The process for building a survey or questionnaire is very similar to the process for building data entry forms. A simple \u201cenabling\u201d of the form as a survey will allow for the survey distribution features to be activated. Individuals can either input their own instruments or use validated surveys and forms from the REDCap Library. The necessary citations and permissions are included in the REDCap library. If clinical research professionals input a new instrument by hand, they must ensure that the proper licensing and citations have been included, if it is required.<\/p>\n\n\n\n

        Subjects can complete surveys or questionnaires online through links that a clinical research professional sends them remotely, online in-person during study visits, or by hand during study visits. Clinical research professionals can use single survey links at any time, or, in a longitudinal study, subject specific links where subjects will take the survey at different time points.<\/p>\n\n\n\n

        During study visits, subjects can complete surveys or questionnaires in-person using the clinical research site\u2019s account. They do not need to utilize their own REDCap account. Responses generate individual record IDs, which can be identified or de-identified depending on the survey purpose. As mentioned, clinical research professionals can also print surveys or questionnaires for subjects to complete by hand. Everything that is created in \u201cDesigner\u201d can be downloaded as a PDF.<\/p>\n\n\n\n

        Clinical research professionals can distribute a survey or questionnaire publicly or to specific subjects. \u201cSurvey Distribution Tools\u201d in the toolbar has options for \u201cPublic Survey Link,\u201d \u201cParticipant List,\u201d and \u201cSurvey Invitation Log.\u201d \u201cPublic Survey Link\u201d is not automatically subject-specific; clinical research professionals can send the same link to everyone. The link can be sent out by email or it can be copied into a social media post or advertisement. There is also an option for using reCAPTCHA, which ensures that robots do not answer the survey. Using a \u201cPublic Survey Link\u201d is easy. The survey can always include an option to have the respondent input their email or name so the response can be matched to the respondent. It is important to remember in this case that no unauthorized user is able to access a respondent’s personal information (can be reviewed in user rights).<\/p>\n\n\n\n

        Subject-specific distribution increases retention by clinical research professionals to email a specific link to specific subjects at scheduled distribution times. This is especially helpful for sending surveys for longitudinal studies. Clinical research professionals compose an email for the survey in REDCap and can distribute it immediately or at a specific time. This feature has an option for reminders if the subject has not completed the survey by a certain date. Reminders can be set for once a week, every day, or another time period. Clinical research professionals can send multiple surveys at the same time by putting them all into a \u201cqueue.\u201d Once the respondent has completed the first survey from the link sent to them, the next survey would appear.<\/p>\n\n\n\n

        As mentioned, The REDCap Library is a repository for data collection instruments that have been uploaded and reviewed by the REDCap Library Oversight Committee. As of September 2022, REDCap had more than 2,000 validated data collection instruments. Clinical research professionals can download data collection instruments as an Excel, CSV, or Zip file and then add them into their project.<\/p>\n\n\n\n

        Recruitment and Outreach <\/h5>\n\n\n\n

        While REDCap is very helpful for collecting data and distributing surveys, it is also an excellent tool to assist in the recruitment of subjects. Clinical research professionals can use the public survey link option to attach information or surveys into advertisements to market their studies through social media, email lists, and so forth. Clinical research professionals can use public surveys to collect screening information and gauge potential interest in studies.<\/p>\n\n\n\n

        Using REDCap for recruitment and outreach enables clinical research professionals to reach many people at one time. The \u201cRecord Status Database\u201d allows for responses to be easily seen and analyzed.<\/p>\n\n\n\n

        User Rights<\/h5>\n\n\n\n

        When creating a project in REDCap, the individual who creates the project and the principal investigator, if assigned, are users. Other users can be added to a project in the \u201cUser Rights\u201d tab in the toolbar. Anyone who has a REDCap account at your institution can be added to a project. Custom rights can be assigned for individual users. For example, medical students and interns can be added with view-only<\/p>\n\n\n\n

        rights. If a specific role is commonly used, such as coordinators, those rights can be saved under the role and be quickly assigned to future hires. People will have different rights, depending on the project.<\/p>\n\n\n\n

        Managing Data and Additional Features<\/h5>\n\n\n\n

        Once all of the data has been collected, it can download data by authorized users in a variety of formats, including Excel or certain statistical software such as R Statistical Software or Stata Statistical Software. REDCap also has its own automatic statistical analysis option. This is great for general data analysis, such as measuring blood pressure. For more specific statistical analysis, having the ability to download the data and use other statistical software is very beneficial.<\/p>\n\n\n\n

        Data can be downloaded with or without protected health information. Users can download the entire dataset for the project or choose specific data, for example, demographic data only or data from the first study visit.<\/p>\n\n\n\n

        Additional REDCap features include a mobile application, multiple language options, a project dashboard, and logging. The mobile application provides quick access to REDCap for users and can be used without Internet access. It is secure and complies with the same regulations as the desktop version. Data in the mobile application can be easily transferred to the desktop version.<\/p>\n\n\n\n

        Multiple languages are available in REDCap, making it easy to translate information for subjects. The project dashboard serves as a news board for each project. It can be made available to subjects as well as to REDCap users. Clinical research professionals can upload articles, posters, abstracts, and other files to the project dashboard.<\/p>\n\n\n\n

        Logging enables clinical research professionals and monitors to log the use of REDCap on each project by users, subjects, and potential subjects. Every time a user logs into REDCap, edits something, or a subject responds to a survey, REDCap logs this, while time stamping and coding the activity. This feature enables clinical research professionals to identify when errors or non-compliance occur.<\/p>\n\n\n\n

        Conclusion<\/h5>\n\n\n\n

        REDCap is an efficient tool for collecting data for clinical research purposes. Since more than 6,000 institutions utilize REDCap, clinical research professionals likely have REDCap at their fingertips. If not, REDCap is available free of charge for non-profit organizations. For-profits can utilize REDCap Cloud, which offers fee-based hosting.<\/p>\n\n\n\n

        REDCap is not open source and requires the use of a standard simple licensing agreement. Also, it is not available for individual use. Training videos, FAQs, and more are available on REDCap\u2019s website. Upon request, REDCap staff at Vanderbilt University can provide training sessions for IT departments or research teams. Considering the ease and accessibility of REDCap for clinical research and beyond, it is safe to say that many can benefit from its use.<\/p>\n","protected":false},"excerpt":{"rendered":"

        Several types of projects can be developed in REDCap. A traditional project is a blank slate. It can be used in a variety of ways, such as a data entry form. For example, a traditional project can be used to record subjects\u2019 vital signs or demographic data. 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