Overview of Workflow
……..Why use REDCap?
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.
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 production-level database is possible in less than one day.
Easy – Intuitive user interface and work flow, readily available online training materials, and assistance from the Center for Health Insights (CHI) make it easy to get started.
Full customization – You are 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 R) 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, and more!
Study Design: Before beginning a REDCap project, you should 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 your study is a research project with human subjects, you likely need the documented approval of your Institutional Review Board. For more information, see the IRB-relevant sections of this guide.
Request New Project: In order to manage the volume of projects being hosted by our servers, you must submit a request to us via REDCap in order to begin a new project. The approval process generally takes less than 2 business days (48 hours).
Design Data Forms: In order to effectively collect and order your data, you must first design the data collection forms to do so. This step is the highlight feature of REDCap: immensely customizable, expandable, fluid data forms.
Testing: You should 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 your study enters Production Mode, you may 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 you enter production and find that you do need to modify an element of your data entry forms, you may 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 you may view and analyze data. You can initiate this mode if you want to ensure that no new data entry will occur, but you would still like to access all of your data easily.
Archived Mode: If you have completed data analysis, moved your project to indefinite hiatus, or simply decided you no longer wish to use it, you may move the project to archived status as an alternative to full deletion. You can un-archive your project at any time.
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. (See also: Development vs Production Modes.)
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. (You may label this differently in your project, but the ID must remain the first field in the first data form.)
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).
Before Requesting a Project
……..Signing in for the first time
The first time you log in to REDCap.umkc.edu, it will prompt you for your basic information in order to verify your account.
Once you submit this information, an e-mail will be sent to your UMKC account.
Click the link in that e-mail to verify your account, and you’ll be all set to use REDCap!
……..Things you should already know about your project
There are several things you should already know about your project before submitting a project creation request. The following items are intended to provide a starting ground for prior knowledge, but this will vary on a case-by-case basis. Some studies may have far more than this planned out already, while others may still be defining the basics.
- The end goal(s) of your research
- The specific data you are going to be capturing
- The type of study you are performing (longitudinal, cross-sectional, etc.)
- Who will comprise your research team
When you meet with us for your consultation, one of the points we will discuss is your IRB protocol. We recommend designing your data forms in REDCap before submitting your final IRB protocol for approval, so that you may include PDF versions with your IRB submission. Whether you are in the beginning or ending stages of IRB approval, we will likely be able to assist and support your project.
You will need IRB approval to conduct human research. Conducting human research without IRB approval will place the University out of compliance with Federal requirements that regulate research involving human subjects. This can result in Federal or IRB actions that will prevent you, your department/division, or the University from conducting research involving human subjects. It will also jeopardize the University’s human research certification with the Office for Human Research Protections (the FWA).
Data collected without IRB approval cannot be used in class research, theses, or dissertations, which may ultimately prevent students from fulfilling graduation requirements.
Thus, an IRB number will be required before we will be able to move your project to “Production” (official deployment) status. You may enter practice data for the express purpose of testing your data forms, but you absolutely may not collect real data for research involving human subjects until you have explicit IRB approval.
…….…..Do I need IRB approval?
NOTE: The Center for Health Insights will not make this determination for you. If in doubt, we recommend consulting your IRB. The following information may help you prepare for that conversation.
The Institutional Review Board (IRB) is an independent, academically-based committee constituted of medical, scientific, and non-scientific members whose responsibility is to ensure the safety, well-being, and the protection of the rights of human subjects who take part in research studies. The IRB reviews research in accordance with the Department of Health and Human Services (DHHS) and the US Food and Drug Administration (FDA) regulations.
If your study involves research using human subjects, you likely need IRB approval before you will be able to conduct the study. The federal definitions are as follows:
Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human subject: a living individual about whom an investigator (whether professional or student) conducting research obtains
Data through intervention or interaction with the individual, or
Identifiable private information.
A research protocol may qualify for exemption if it meets certain criteria. View the IRB exempt research categories section for the detailed federal list.
…….…..IRB exempt research categories
The following describes human subjects research that qualifies for exemption from IRB review based on the Federal Register Title 45 § 46.101. IRB exemption status cannot be self-determined. All exemption determinations are made by the Research Compliance Office. If you believe that your protocol qualifies for exemption, please contact your institution’s IRB for submission instructions and guidance.
Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:
(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
(5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
…….…..Obtaining IRB approval
If your research is based at UMKC or Truman, go here to learn how to apply:
If your research is based at Children’s Mercy Hospital, go here to learn how to apply:
If your research is based at St. Luke’s Hospital, go here for relevant application documents:
…….…..Citing REDCap in your IRB protocol
Below is the recommended REDCap documentation for the Data Management section of your IRB protocol:
“The Center for Health Insights of the University of Missouri–Kansas City (UMKC) will be used as a central location for data processing and management. Vanderbilt University, with collaboration from a consortium of institutional partners, has developed a software tool set and workflow methodology for electronic collection and management of research and clinical trial data. REDCap (Research Electronic Data Capture) data collection projects rely on a thorough study-specific data dictionary defined in an iterative self-documenting process by all members of the research team with planning assistance from the Center for Health Insights. The iterative development and testing process results in a well-planned data collection strategy for individual studies. REDCap servers are housed in a local data center at the University of Missouri–Kansas City and all web-based information transmission is encrypted. REDCap was developed specifically around HIPAA-Security guidelines. REDCap has been disseminated for use locally at other institutions and currently supports over 1000 academic/non-profit consortium partners on six continents and over 100,000 research end-users (www.project-redcap.org).”
Initial Project Set-Up
……..Requesting a project
Submitting the project request is very simple. You will need to provide a project title and purpose. You have five options for project purpose:
If this is your first project in REDCap, we recommend selecting “Practice / Just for fun.” This way, you can explore the various functions of REDCap and become acquainted with it before implementing a full project. See the Project types section for more details about the various project types. If you select the Practice option and later decide you would like to turn it into your official project, you may amend the project purpose on the main Project Setup page. Your project’s title can be changed at any point in Development.
Notice the “Start project from scratch or being with a template?” option. 95% of the time, you will want to begin your project empty (blank slate) so that you can design it to your exact specifications. However, there are many templates available that have forms designed already, which can be added to and modified to fit your project’s needs. This is not the only opportunity you will have to access these general forms: during the process of project design, you may also visit the Shared Library to add template forms to your project. See the Project templates and Shared Library sections for more details.
When your request is sent, this message will appear, and we will be able to approve your project so that you may begin. Project approvals will generally be granted within 1-2 business days (24-48 hours) of the request.
Once we approve your project, you will receive an e-mail similar to the one below confirming approval and providing a link to your new project. You can also access the project by simply logging into redcap.umkc.edu and clicking the “My Projects” tab.
[TIPS AND TRICKS]: If you’ve completed a consult with us about your study, we will be anticipating your project request, and it will get approved more quickly. In addition, any questions or concerns that we would have about your project will have already been discussed.
When you first create your project, you will be asked to select a project purpose. You have five options: Practice / Just for fun, Operational Support, Research, Quality Improvement, and Other.
If you choose Practice / Just for fun, you will not be prompted for any additional information. This type is, as the title suggests, intended for practice purposes: to become familiar with the features and learn about REDCap.
Operational Support projects are generally intended for the management and monitoring of a system or technical environment issues. This can include management of an organization, bug report tracking, project tracking, and more.
Quality Improvement projects include projects such as evaluation surveys and suggestion forms. These projects can help channel organizational goals and facilitate performance improvement.
If you select Other, you will be prompted to briefly describe the intention of your project. If we have further questions about your project type, we will contact you before approving your project.
Selecting Research will prompt many new fields:
Fill out as much as you can before submitting your project request. If you do not have all of the information at the time of your project request, do not worry about it – you can add these details later, as long as they are all completed before launching into Production phase. In fact, we recommend that you wait until after designing your REDCap forms to submit your study to the IRB: this way, you can convert your forms to PDF documents and include them with your IRB submission.
For other topics that might be considered “Project Types”, see:
- Longitudinal studies
- Survey-based studies
- Multiple treatment groups (Arms)
When requesting your project, you will generally want to select the “Create an empty project (blank slate)” option. This will allow you to customize your project to your exact specifications. However, if you would like to select a template to base your project upon, several are available.
The templates have varying numbers of data forms, each with a set of pre-specified fields. If you do decide to use a template, new forms/fields can still be added and existing forms/fields can be modified or deleted if you choose. The structure is still very flexible; this can just give you a base upon which to build your project.
If you create an empty project and later decide that you would like to use pre-designed forms, you may access the Shared Library to import forms that other REDCap users have uploaded. The Shared Library has many more options than the project templates. See the Shared Library section for more details.
……..“Development” versus “Production” modes
You will begin your project in Development mode. This means that you are still in the process of designing and testing your data collection instruments. Everything can be modified freely in Development mode. If you are conducting a research study, your IRB number is not required until you move into Production mode.
Once you feel ready to deploy your project, you may request to have your project placed into Production mode. At this point, you should have fully tested the workflow, data validation and branching logic: you should be certain that your data forms are finalized and fully functional. You should also have your IRB approval number, if applicable. If this was not added to your project when you initially created it, you may add it under “Modify project title, purpose, etc.” on your main project dashboard.
Moving your project to Production prior to collecting real study data ensures you are maintaining data accuracy and integrity. The post-production control process provides an additional check to ensure that data in your records is not modified, deleted, or overwritten unintentionally. In addition, it allows us to have a check point at which we require IRB numbers for validation; otherwise, we would have to require them at the time of project request.
See the Beyond Development Mode sections for details about other project modes available after moving into Production mode.