REDCap

>> REDCap access is not automatic.<< There are steps that must be completed before access is granted. 

There are two roles within REDCap: 1.) Project Owner & 2.) REDCap User

• A REDCap Project Owner is the requestor of a new project.  This individual will be the "owner" of the project and is the primary contact who is responsible for the administration and design of the project and those accessing it.  While the PI is ultimately responsible for the project and its data, in most cases the Project Owner is not the PI.  Only one Project Owner is allowed per project.
  
  
• A REDCap User is a study team member who is accessing a project in which permissions are granted by the Project Owner.  A study team member can include affiliates from other institutions who are listed as external team members on the NU IRB.  Affiliate NetIDs can be obtained by NUIT if the Project Owner (or their admin) requests it on the Affiliate's behalf. 

Our support model is simple, we train the Project Owner so that they are prepared to administer permissions and support the users in which they are going to grant access to their existing project(s).  All new REDCap access permissions begin with the Project Owner. The Project Owner must distribute the REDCap User Agreement to the new user in order to initiate the access permission workflow.  Once the new user signs the REDCap User Agreement they will receive a notification with the next steps for REDCap access. In order to prevent delay, Project Owners MUST distribute the User Agreement as contacting REDCap Support will only delay the access rights.

When a user signs the REDCap User Agreement to initially gain access, they are automatically granted REDCap SSL VPN permission.  REDCap SSL VPN permission is needed if you are accessing REDCap remotely by logging into the SSL VPN link at www.vpn.northwestern.edu.  Notifications are sent out approximately one month prior to expiration.  If you need this permission renewed and are NOT the Project Owner, you will need to have your Project Owner send REDCap Support an email to request an extension (you do not need to email NUIT or FSMIT).  

If you have downloaded the REDCap NU Global or Native VPNs to access NU systems remotely, then this permission is not really needed as you are accessing REDCap while on the NU Network via the NU VPN.  If you log onto REDCap directly after logging into the NU Global or Native VPN you can let this permission for the SSL VPN expire.  

There are a few things to consider when logging into REDCap.  

1. REDCap can only be accessed while on the NU Network.  The direct REDCap link only works if you are already on the NU Network.  If you are attempting access remotely, you must be logged into the NU Global/Native VPN or the SSL VPN in order to access.  The SSL VPN link is www.vpn.northwestern.edu.  Please remember, SSL VPN permissions expire annually.  If you are attempting access via the SSL VPN but do not see the REDCap link you likely let it expire.  Contact REDCap Support for renewal of the REDCap SSL VPN permission.  
2. REDCap uses your NU NetID via LDAP for access. If you forgot your password or need to reset it, please do so via NUIT and NOT the REDCap page.  The REDCap "Reset Password" feature does not work. 
3. Only Project Owners can grant access to a specific project.   Once you have signed the REDCap User Agreement, you will be granted access to the system only.  Project Owners must add users to their specific project.  Please do not contact REDCap Support for project specific access.  Contact the Project Owner directly. 

Only Project Owners can request new projects to be created for them.  You will learn about all the duties of a Project Owner and system usage requirements in the REDCap New Project Owner Training Session.  This training is completed on-line and will take approximately one (1) hour to complete.  If you are interested in becoming a REDCap Project Owner, send your request to REDCap Support via email.  

REDCap Project Owners must be NU/NM/Shirley Ryan/Lurie Children's staff and FSM Affiliated. 

Only those who have completed the REDCap New Project Owner Training can request projects to be created for them.  You will not see the "Create Project" option in REDCap as only REDCap Support Admins have this permission.

If you have completed the REDCap User Agreement and the New Project Owner training, you can request a  new project by filling out the REDCap project request form.  REDCap Support will create the project for you.  Requests are generally completed within one business day of the request submission. 

A webinar recently took place on this topic and includes many details that are beneficial when considering the use of REDCap for eConsent.  Learn the benefits of the eConsent Framework and Study Tracker push while obtaining some important tips and steps for setup.  The webinar session is only available after logging in with your NU NetID and while on the VPN.  The video is ~40 minutes in length. 

You may access the video here.

In order to utilize REDCap for eConsent for FDA studies you must adhere to 21 CFR Part 11 compliance requirements. 

1. The Project Owner (requestor of the project) must have completed the required training specific to 21 CFR Part 11 Compliance in addition to the REDCap New Project Owner Training (if they are new to REDCap). 
2. The Project Owner must have signed the attestation form.  This form is part of the training and is required in order to be able to request projects for this purpose. 
3. Follow the workflow described in the training and incorporate the requirements into the approved compliant workflow template found in this eConsent: 21 CFR Part 11 Compliance Framework for FDA Studies document. 

Once Steps 1 & 2 above are completed, the Project Owner will be able to request a new project with the approved template.  REDCap Support will create the project for you with the template already uploaded for you to begin updating to reflect your study's NU IRB approved language.