Regulatory requirements

OCTRI staff conducts brief regulatory reviews for all REDCap project requests involving human subjects research. Study teams must include language about their data management systems in the protocol.

IRB approval is not required to start building a project, but it is required to finalize the project setup (i.e. push to production) and collect real data.

• Human Subjects Research Studies: Regulatory Basics for REDCap Success! 
• Boilerplate REDCap language

Help and support

For research studies, the support model consists of two support tracks: 1) Supported Service, and 2) Self-Service. 

The Supported Service track is designed to offer the broadest use of and support for REDCap, by making available help from the REDCap team and use of the full REDCap feature set, in exchange for the persons building and managing a project completing the required training(s). This means builders of all levels can access the REDCap Team's expertise as they learn and grow their skills in the software, and study teams are not limited in determining what functionality will best meet the requirements for their data collection, monitoring and reporting. 

The Self-Service track is designed to streamline the process of setting up and managing a simple REDCap project by eliminating the REDCap training and testing requirement as conditions for getting started and launching a project to production, in exchange for limiting the use of REDCap to features and functionality that don't require the REDCap Team's assistance for implementation, guidance or review for utilization or ensuring compliance. In practical terms, this track is best suited for experienced builders setting up a simple project that they will also be managing over the course of the project’s lifespan. 

For both support tracks, learn more about our model of support. 

Costs and charges

For research projects, there is no cost for support and help activities for the core functionality that's covered in our Basics and Survey trainings. Currently, there is no cost for project hosting and data storage for the first year of a project's existence. There are charges for custom support, which is for additional help for builders and persons managing projects looking to accelerate their learning, to get advice in applying the concepts covered in trainings and in the wiki to the context of their study, or to get hands-on help or advice with complex problem solving and project set up activities. Charges are determined on a case-by-case basis per project and depends on the level of the support and scope of the work.

There are annual fees for accounts for external users for using some optional or peripheral modules/functionality.

Learn more about costs and charges.

Help and support

There is a single track of support for all non-research projects, the Supported Service track. The Supported Service support track for non-research is focused on making available use of standard “out-of-box" REDCap features and providing help with the core REDCap functionality that's covered in our Basics and Survey trainings. This approach puts into place support for non-research use of REDCap, and, at the same time, addresses the increasing constraints on resources to support an application that is evolving in complexity and a user base that is expanding in size. 

Learn more about our model of support. 

Costs and charges

There is an annual fee that covers project hosting, data storage, and email and drop-in help.  

There are also annual fees for accounts for external users. 

There are charges for custom support, which is for additional help for builders and persons managing projects looking to accelerate their learning, to get advice in applying the concepts covered in trainings and in the wiki to the context of their study, or to get hands-on help or advice with complex problem solving and project set up activities. Charges are determined on a case-by-case basis per project and depends on the level of the support and scope of the work. 

REDCap learning curve

The phrase "learning curve" is used colloquially. In this context, we are referring to the time and effort it takes to learn to use the software to build a project. We're also speaking about the learning curve in generalities, given that a variety of factors impact an individual's personal learning curve, such as familiarity with collecting research data, exposure to other data collection systems, and comfort learning new technology.

Our Basics and Survey trainings are intended to jumpstart the learning process by introducing builders to core and commonly used functionality, as well as established best practices for setting up a project. In general, we think of the REDCap learning curve as flat, meaning it's easy to get started, but is also long. This is because the builder will need to invest time in applying the materials we cover in training to the context of building a project for their study's requirements, and because REDCap is such a feature rich application that a builder may work on several projects before they need to learn how to use a particular feature.

Additionally, some features steepen the learning curve, and by this we mean some features are harder to learn. Examples include the functionality associated with setting up projects for sending out surveys, using REDCap for obtaining consent, and building projects for multi-site data collection.

Learning tips

• Complete our REDCap trainings
• Plan to learn as you build your project
• Read documentation in REDCap and on the wiki to try to answer your own questions
• Ask for help from a colleague or the REDCap Team

Building time

Data collection forms

When teams new to REDCap plan for the effort involved in building a REDCap project, they tend to focus, almost exclusively, on how long it will take to build out their data collection forms. While there is not a formula that can reliably calculate the total amount of time a project team will need to invest in form building, a key consideration to start with is that we approximate it takes between 1 to 5 minutes to create a single field.

Additional considerations

Besides planning time for building forms, which typically requires the largest investment of time, teams should plan time for other activities that are commonly involved in project building, such as:

• Setting up the data entry workflow
• Entering test data to validate all forms are functioning properly and are optimized for reducing errors and inconsistencies during data entry
• Exporting data and the codebook to review with the analyst
• Assigning users and testing that their permissions match up with their role on the study

Additionally, some building activities are more time intensive, like setting up forms to be surveys that can be sent to out to participants to complete on their own. This effort almost doubles the amount of building time the team should plan for.

Testing time

Building time also includes testing time. Testing is the other activity that usually requires a large investment in time, effort, and coordination, if all the stakeholders are involved in testing and vetting the project, which is highly recommended. The expectation is that before collecting real data, the project team will test all of the features the builder has set up to support data collection and project management. Testing is the only way to determine whether or not the project has been built in a way that it can collect the data required to answer the scientific question posed by the research or address the issue a team is trying to evaluate or track for non-research activities.

Best practices for success

Lastly, even if we don't have a formula to estimate the hours a team should plan to spend on project building, we do know there are certain activities or practices that can help mitigate the amount of time and level of effort a project build can take, such as:

• Finalized data collection requirements
• Designating a person to organize and manage the building activities
• Stakeholder engagement in creating the data collection plan, as well as testing and validating the project build
• Builder access to source documentation, such as a data dictionary or paper CRFs

Model of support

The model of support for REDCap was designed with two intentions in mind: 1) to work with research and non-research projects in a manner that is both sustainable and beneficial for an application that is evolving in complexity and a customer base growing in size, and 2) in consideration of REDCap’s intended use and OCTRI’s mission, both of which are focused on supporting research. 

At the center of the support model are the three unique support tracks. Each support track defines how a project team gets help from the REDCap Team and sets parameters around the kinds of features and functionality that are available for use in their project. 

Support Tracks 

• Supported Service for Research expands on the support OCTRI has been providing for REDCap since its adoption at OHSU. All research projects are opted into this track because Supported Service offers the broadest use of and help with the application in exchange for the person building and managing a project completing our required training(s), and the study team completing project testing before launching their project to production. 

• Self-Service for Research support track provides a pathway for an experienced builder to opt to set up and manage a simple project by eliminating the REDCap training requirement as a condition for getting started and the testing requirements as a condition for launching a project to production, in exchange for limiting the use of REDCap to features and functionality that don't require the REDCap Team's intervention for implementation, or guidance for utilization. 

PrincipaI investigator (or data steward for non-research projects)

• Designate a builder
  The number one key to success is designating the "right" person to be the builder/point person for the project and supporting the time investment they will need to:
  • Learn the software
  • Familiarize themselves with our operations
  • Build the project
  • Train the other team members on how the project is built to capture data

In our experience working with study teams since 2007, the "right" person is usually a study coordinator or research coordinator, who is motivated to learn new technology, can collaborate with stakeholders to gather requirements, and will be working on the study for its duration. Interns and students, who may only be assigned to a study team for 2 or 3 months, can help build a project, but are usually not the best match to take the lead on a project build.

• Engage stakeholders
  Identify the personnel who will be entering data and conducting analysis to collaborate with you and the project builder to:
  • Develop requirements for the project
  • Test and validate the project build
     
• Provide oversight for compliance
  The principal investigator (or data steward for non-research projects) is responsible for ensuring the use of REDCap is in compliance with 1) the protocol, 2) regulatory requirements, and 3) institutional security directives.

Builder and/or point person

• Invest in learning
  Trainings are intended to jumpstart the learning process and review operations for using REDCap at OHSU. The larger part of learning happens as builders apply the materials covered in training to the context of setting up a project to meet their study's requirements and identify when they may need additional training or instruction to learn about using advanced or optional features.
   
• Transform requirements into REDCap solutions
  Requirements define what data is being collected, when and how the data will be collected, and what kinds of reports the study team needs for data monitoring and data analysis. REDCap solutions refer to specific features and functionality for collecting data and managing the data collection workflow. For example, a feature as simple as a validation rule is a solution for reducing data entry errors and inconsistencies by restricting the type of data a user can enter in a text input field.

• Embrace point person responsibilities
  Every REDCap project is required to have an OHSU point person, typically the builder, to manage the following activities for the team:
  • Provide guidance and expertise to the other members of the team regarding how the project is set up
  • Be the first point of contact for trouble shooting issues and answering questions about operations
  • Reach out to the REDCap Team to get answers or when additional support is needed

Data analyst

• Help develop requirements
  Collaborate with the PI, the builder, and the data entry person to ensure that requirements take into account not only what data needs to be collected for analysis, but how the data needs to be collected for analysis. For example, are there coding requirements for categorial data?
   
• Learn REDCap from an analyst's point of view
  • REDCap exports longitudinal and repeating data in a long format.
  • REDCap has export options for commonly used stats packages, such as SPSS, Stata, SAS, etc.
  • REDCap has tools the study team can use to help with data cleaning, including record locking, missing data codes, data quality rules, and a data resolution workflow.
     
• Validate the build
  Before the project is moved to production, coordinate with the builder to review the codebook or data dictionary, and coordinate with data entry personnel to ensure there is test data that can be exported and reviewed.

Data entry

• Help develop requirements
  Collaborate with the PI, the builder, and the data analyst to ensure that requirements promote data collection strategies that are optimized for both increasing efficiencies, as well reducing inconsistencies and errors in entering data.
   
• Learn REDCap data entry tools
  • Create and edit a record
  • Record status dashboard
  • Form status
     
• Test the data entry workflow
  Before the project is moved to production, coordinate with the builder to enter test data and provide feedback.

OCTRI REDCap Basics Training for Project Builders

Our Basics Training for Project Builders eLearning course will introduce you to the key OCTRI operations and the core REDCap functionality that is foundational for all REDCap projects. No matter what kind of project you'll be building or what kind of data you'll be collecting, our training will help you get a strong start.

• This eLearning course is designed for individuals who are building or modifying REDCap projects (i.e. project builders/point persons).
• This eLearning course is not designed for individuals who are performing data entry, data analysis, or data management for a REDCap project.

Register for the REDCap Basics Training for Project Builders eLearning. 

OCTRI REDCap Survey Training Sessions

Our Survey Training will introduce you to the key OCTRI operations and the core REDCap survey functionality that is foundational for all survey projects. No matter what kind of survey project you'll be building or what kind of surveys you'll be sending out and collecting, our training will help you get a strong start.

• This survey training is designed for individuals who are building or modifying REDCap projects that will be sending out surveys to participants and collecting their responses.
• Completing Basics training is a prerequisite for registering for a survey training session.

Register for a Survey Training Session. 

OCTRI REDCap Drop-in Sessions

Drop-in sessions are for the point persons building and managing projects using the Supported Service for Research or Supported Service for Non-Research support track. Drop-in sessions are to get in-person help with: 1) problem solving related to the core functionality that's covered in our Basics and Survey training, 2) guidance regarding survey setup, survey distribution, and pre-production survey reviews, 3) tips for getting started with advanced features, and 4) guidance and help for making production changes. 

OHSU Resources

• Basics Training for Project Builders
• Survey Training (Basics training required)
• Instructions for using REDCap for E-Consent
• REDCap wiki

Resources in REDCap (log in required)

• REDCap FAQ
• Videos in REDCap