This page covers requirements related to using REDCap.

NOTE: There is not a training pre-requisite to gain access to REDCap. Additionally, there is not a general orientation to REDCap or a general training for users other than those listed below for the project builder.


Model of Support Key

Standard Service for Research

Self Service for Research

Standard Service for Non-Research



Training for Project Builders

Training is provided for OHSU or eligible Portland VA personnel requesting and building projects. Training requirements are dependent on the project's support track.

  • Basics Training

    • Required for personnel building REDCap projects using the Standard Service and Supported Non-Research support tracks. 

  • Survey Training Class

    • Required for personnel building projects using Standard Service and Supported Non-Research support tracks to send out surveys and collect responses through REDCap.
    • Completing Basics training is pre-requisite.

  • E-Consent Training

    • Required for personnel using REDCap for e-consent.
    • Completing Survey training is a pre-requisite.

  • Training is for OHSU and OCTRI partner personnel, such as Portland VA building projects.

    • Training and support is not provided for other external collaborators to build projects in OHSU's REDCap


Visit Training & Learning Resources page for more information.



Accounts for Personnel using REDCap

The following is an overview the pertinent user requirements for personnel using OHSU's REDCap. Please find more details in the section on User Management and User Operations.

Only individual user accounts are allowed in REDCap. Per OHSU security directives, accounts cannot be shared and shared accounts cannot be added to projects.

Training is not required and there is not a general orientation to REDCap or training for users other than those listed above for the project builder.

  • OHSU Personnel

    • OHSU users log into REDCap and set up their accounts without intervention from the REDCap Team.
    • This is a manual process managed by the OHSU user.
      • OHSU personnel log into and use REDCap with their OHSU username.
      • The first time OHSU personnel log into REDCap, they will be prompted to set up their profile.
      • OHSU personnel are required to use REDCap with their OHSU email address.

  • External Users

    • Accounts for external collaborators are added to REDCap at the request of project/study team
      • There is a link to the form for requesting external users accounts on each project's User Rights page.
      • OCTRI partners & external collaborators are required to use REDCap with their institutional or organizational email address.
      • Accounts are created for the exclusive use of the external collaborator and sharing the account would be a violate OHSU security policies.

  • Accounts cannot be shared and shared accounts cannot be added to REDCap as users.

Training and support is not provided for external collaborators to build projects in OHSU's REDCap.


Visit Managing Users & User Operations page for more information.

Types of Data Collection Allowed

The following types of data collection are supported in OHSU's REDCap.

  • OHSU Research Studies

    • Investigator initiated research studies (that are not FDA regulated (21 CFR Part 11))
    • IRB or IACUC approval not required to create and build a project.
    • IRB or IACUC approval required to moved a project to production.
    • Exempt research projects determined by IRB, NOT the researcher.

  • OHSU Non-Research Projects

    • Non-research projects collecting any patient or patient data are required to submit to IRB for a determination of non-research.
    • Non-research projects collecting identifiers/PHI are required to submit additional documentation.
      • Clinical non-research data stored in REDCap cannot be used for medical decision making or appended to the patient's medical record.

  • Is a project research or not research?

    • Submit a request for determination to the IRB.


Project Point Person

Requirements

  • Build and/or manage the project build.
  • Adhere to help and support operations that correspond to the support track selected for the project.
  • Review the final set up and design of the project before moving the project to production.
  • Complete the following required trainings and forms for projects for each track type (see Model of Support Key):
Applicable TrackRequired and Trainings and Forms by Track

 

Basics training for Project Builders

 

Survey training (if your project includes survey functionality)

         

Self-directed e-consent training if you will be setting up your project for e-consent (including Information Sheets)

           

Builder Agreement form and/or Supplemental Intake form prior to starting build


Expectations

  • Disseminate REDCap operations and requirements, reviewed in training, with the rest of the project team.
  • Share pertinent information with the project team about the model of support.
  • Coordinate or carry out user management for the project.
  • Train the project team regarding data entry workflow and data entry activities for the project.
  • Manage change in production.
  • Arrange for a handoff of point person duties (see below), in the event a new point person takes over.
  • Be the point of contact for email help.
  • Be available to attend drop-in sessions, as needed, for in-person help.
  • Comply with all regulatory requirements and institutional security and privacy policies that apply to the data you plan to collect.

Transferring Point Person to Another User

It's not unusual for a project to transition between multiple point-persons over its lifespan. In the handoff from one point-person to the next, it's important that the study team be able to continue managing the project successfully. Here are some tips and considerations for making the transition as smooth as possible.

User Requirements 

Eligibility Requirements

  • OHSU or VA personnel
  • Must be a user on the project
  • Permissions enabled for User Rights on the project

Training Requirements

The new point-person will need to meet the Basics training requirement to assume point-person duties. If the project includes Survey functionality, the new point person will need to complete both Basics and Survey training before taking over the project. If the new point person has completed all required trainings, you may email redcap@ohsu.edu to request that the point person be changed.

Knowledge Transfer

Ideally, a one-on-one meeting between the departing builder and the person who will be taking over. A direct discussion can be a great way to pass knowledge of problem areas, or aspects of the project that require maintenance or just keeping an eye on. Of course, it's not always possible for this kind of discussion to take place. It becomes more important than ever to document the functionality of the project in a manual of operations (MOP). This could be in something as simple as a Word .doc saved in a location available to team members, or within the project itself using a Project Dashboard. The best time to assemble the MOP is when the build has been finalized, and the specifics about the build are fresh in mind. Any subsequent changes to the project should trigger an update to the MOP.

The knowledge transfer would cover:

  • What functionality the project uses:
    • For all projects:
      • How are records created or named?
      • Is the project longitudinal?
      • Are Alerts & Notifications used?
      • Etc.
    • For survey projects:
      • Are Automated Survey Invitations configured?
      • Is the Survey Queue utilized?
      • What Survey Settings are enabled?
      • Etc.
  • What the daily, weekly, or monthly operations of the project are.
  • Management operations like onboarding new team members.
    • What privileges or training would a new person need to begin working in the project?
    • Does the new user need a new role, or fit into an existing role?
  • Roadmap for the project.
    • Where is the project going?
      • It is in development and in need of further building?
      • Is it in production and need new functionality?

Revisit User Management

Although, user management might seem like a set-it-and-forget-it task, it is critical for protocol compliance, and a part of project maintenance for the life of the study. Any time someone leaves the study team is a good time to go into User Rights and audit project access. Any users listed who have left the team, or are no longer listed on the protocol should be removed. Assess if responsibilities have changed for team members still working on the project, and adjust rights accordingly. 

Sponsorship for External User Accounts

Additionally, if the the point person is sponsor for any external user accounts, he/she/ they should reach out to REDCap Team to transfer sponsorship to the new point person.