FAQ
- Jonathan Kurka
Provided is a list of frequently asked questions from the Arizona State University REDCap users. Solutions to these questions are also available on the help_redcap Slack channel.
The Record Status Dashboard is a table listing all existing records/responses and their status for every data collection instrument (and if longitudinal, for every event).
If an instrument is not showing on the Record Status Dashboard…
Check the Data Viewing Rights within the User Rights module
Navigate to the User Rights module found under Applications in the left-side menu or in the Project Setup page.
Click on the username/role that is unable to view the instrument to edit its privileges
Edit the Data Viewing Rights accordingly
NOTE: when adding an instrument from Draft mode, the default setting is to make the new instrument not viewable within the User Rights for all users. This allows the project designer or user rights manager to assign the instrument accordingly.
The project’s User Rights module defines user-specific abilities, which include the ability to view specific instruments and their data and the ability to export specific instruments and their data. Data Viewing Rights pertain to a user's ability to view or edit data on pages in the project (e.g., data entry forms, reports). Users with 'No Access' Data Viewing Rights for a given instrument will not be able to view that instrument for any record, nor will they be able to view fields from that instrument on a report. Data Export Rights pertain to a user's ability to export data from the project, whether through the Data Exports page, API, Mobile App, or in PDFs of instruments containing record data.
Data Viewing Rights and Data Export Rights are completely separate and do not impact one another.
Navigate to the User Rights module from the left-side Applications menu or the Project Setup page.
Click on the ‘Username or users assigned to a role' for whom you want to review specific viewing or exporting rights.
Click ‘Edit user privileges'.
Make the changes to the exporting rights as needed.
“De-identified” means that all free-form text fields will be removed (e.g. unvalidated Text Box field or Notes Box field), as well as any date/time fields and field marked as identifiers. “Remove All Identifier Fields” means that only fields marked as identifiers will be removed.
To check which fields are marked (or might need to be marked) as identifiers, view the ‘Check For Identifiers’ page from within the Project Setup tab.
Note: for the HIPAA REDCap system, data export rights should only be allowed for the Primary Investigator of the project and should only include “De-identified” or “Remove All Identifier Fields”.
The Code of Federal Regulations, 21 CFR Part 11 indicates criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. If conducting e-Consent, please read through the criteria in the link. If your study needs to comply with the Code of Federal Regulations 21 CFR Part 11, it’s very important to contact the Research Data Management Office for a consultation.
REDCap’s e-Consent Framework is referred to as a 'framework' because enabling this option alone does not provide an e-Consent process but merely provides the general framework or mechanism to allow you to provide e-Consent to patients/subjects. As a survey administrator, you must still create your e-Consent survey and all the questions in it, including name, date of birth, and how you wish to capture the signature. This framework allows you to implement your e-Consent process by providing standardized tools (certification screen + automatic storage of consent form as a 'hard-copy' PDF) while still providing the ability to customize your survey how you wish.
This video found within any REDCap project’s e-Consent module provides initial guidance
Here are some key points to establish a compliant e-Consent process.
IMPORTANT: A template has been created with the following steps already completed plus a consent verification step.
Within your new project, a Project Dashboard named ‘E-CONSENT 2.0 Implementation’ outlines the process to complete the setup and implement this e-consent process. Your e-consent requirements may be different than what is set up in this project. Please verify your requirements with IRB and post to the help_redcap Slack channel if you have general implementation questions.
Steps to set up e-consenting using the e-Consent Framework (from a blank project)
Create a 'Consent' instrument with the following fields:
Consent Form (Descriptive Text field)
First Name - (Text Box field); indicate required
Last Name - (Text Box field); indicate required
The meaning associated with the ‘signature’ (e.g. a Yes/No question asking the participant if they consent to the procedures stated in the approved document) - indicate required.
Date Consented - (Text Box field): validate as a date; indicate required)
Employ the READONLY and TODAY action tags.
Signature field - indicate required
A signature field is optional. Compliance is dependent on participants providing items a-e above, then certifying the information (described below).
Enable the instrument as a survey.
Navigate to the Consent Form survey settings.
Under ‘Survey Customizations’, choose ‘Yes’ to allow participants to download a PDF of their responses at end of survey.
Enable the e-Consent Framework within the Online Designer
Read through the e-Consent Framework description at the top of the page, including the ‘Read More’ section.
Enable the framework for the ‘Consent Form’ survey
Within the e-Consent settings, indicate the First Name, Last Name, and signature (if added) fields.
Add other necessary information as required by IRB
Leave the ‘Allow e-Consent responses to be edited by users?’ checkbox unchecked.
The ‘Consent Form’ instrument must be opened as a survey to activate the process of verifying the consent fields, saving a PDF of the signed consent, and allowing the participant to download the signed version. Here are two ways the instrument can be opened as a survey:
Survey Link: this link can be sent to the participant manually (see next option) or using an ASI
Click ‘Open survey’ in the ‘Survey options’ within the Consent instrument for that record.
Additional information or processes may be required to complete consent. These include verification by study staff, a witness signature, or verifying the participant’s identity. For additional guidance on setting up e-Consents, including requirements to comply with federal and/or funding agency regulations, please post to the help_redcap Slack channel or contact the Research Data Management Office.
Ensure the instrument is enabled as a survey (themes only apply to surveys, not forms)
Navigate to the Survey Settings for that instrument
Scroll down to the ‘Survey Design Options’ and choose a ‘Default’ survey theme or click on ‘Customize’
To customize, alter the colors as desired for each item available.
Click ‘Save custom theme’
This custom theme is now associated with your username and will be available to you on all projects you have ‘Project Design and Setup’ rights to.
The System Documentation & Configurations document specifies the account expirations for both the Enterprise and ESR REDCap systems. The following processes identify how users can extend their accounts.
The primary recommendation to extend an expiring account or reactive an account that has been suspended due to expiration or inactivity is to submit a ticket to ServiceNow. ServiceNow tickets can only be submitted by ASU faculty, staff, and student workers. If the REDCap account belongs to a student, then the ASU personnel supervising the student account will need to submit the ServiceNow ticket.
A secondary process to extend or unsuspend accounts involves navigating to your sponsor dashboard. Note, this is only available for REDCap users that have sponsees assigned to them. If an account has no sponsor, please submit a ticket to ServiceNow for renew/unsuspend requests.
From the My Projects page, navigate to the Sponsor Dashboard.
Select the users whose accounts need extended. Click on the ‘Extend account expiration’ button at the bottom of the page.
Submit the request to the system. The request will be processed as soon as possible.
To create an XML backup, navigate to the Other Functionality
Under ‘Copy or Backup Project’, choose the XML file that you would like to download
If exporting the data also, a window will appear that allows you to specify the type of data to export. Note, if you choose to export any files included in File Upload fields or signatures, the XML file will grow and there may be issues completing the download.
Per the prompt shown in REDCap, deleting records is permanent
If you proceed to delete record(s) and discover this was an error, it is possible to recreate the data in a new record. The project Logging module lists all changes made to the project, including data exports, data changes, and the creation or deletion of users. Using the filtering options, you can find record-specific changes, such as when data is entered for that record. Using this information, you can create a new record and re-enter the data.
NOTE: if recreating data that was completed by participant surveys, the Record Status Dashboard status icon will still reflect how the recreated data is being saved, not how the deleted data was entered. Additionally, survey timestamps can be noted from the Logging module, but cannot be added or edited for the recreated data. If this metadata is needed, it will have to be exported from the Logging module (a CSV file is available) and merged with the exported data file.
If the Logging module is not available in your project, please check your User Rights or contact the project designer, user rights manager, or faculty researcher regarding the issue.
First, check to make sure event referencing is also accurate, if your project contains defined events. Since defined events create additional rows (instead of columns) of data, referencing a variable (i.e. column) also requires defining the row (i.e. event name). For more information, review the instructions found within REDCap.
If event referencing is accurate or not needed, check the source code of the text or temporarily disable a rich text editor. For example, the picture below is accurately referencing a variable in the project that does not contain defined events. To emphasize the text it has been changed to red using the rich text editor.
This example will not work due to HTML formatting that has been added to unbold and change the color to red. Check the source code by clicking the '< >' symbol or uncheck the rich text editor.
Note the formatting that has been added (highlighted below).
Accurate referencing must have the variable, event, or Smart variable referenced within square brackets without extra formatting. Altering the text to the below allows the piping to function with the desired formatting.
