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Table of Contents


FAQ List

Is there boilerplate language for inclusion in grant proposals, manuscripts, and IRB applications?


Any grant proposal where REDCap usage is planned or publication where REDCap was used should include: 1) a short description of REDCap in the methods or other appropriate section in the body of the document, 2) an acknowledgment of grants that support REDCap at Washington University, and 3) citations for the publications related to REDCap and the REDCap Consortium.  This helps ensure that REDCap will continue to receive funding at both Washington University and Vanderbilt University.  Vanderbilt is where the base REDCap software was developed and continues to be maintained.  Example text for each is below.  The text for the methods section also is appropriate for IRB applications.  If you are obtaining sensitive data that will be stored in REDCap, you may need to provide a more thorough description of REDCap security.

Short description of REDCap in method sections of grant proposals, publications, and IRB applications

The examples below can be modified to match your project as long as the overall details of REDCap do not change. The general example should provide sufficient information for most grants and publications.  The example with additional technical and security details can be used for any proposal or publication but all the information is not always required if you are on a word or character count limit.  Please reach out to the REDCap Helpdesk with any questions regarding language in grants proposals, manuscripts or other relevant research outputs.

General Example:

"Data will be collected and stored on the Washington University instance of REDCap (Research Electronic Data Capture) which is maintained by the Institute for Informatics, Data Science, and Biostatistics (I2DB) Informatics Core Services (ICS).  Data stored in the WUSTL REDCap instance in Production Status are protected by multiple layers of security, running on Linux platforms configured for strict user permission policies. All database transactions (i.e. project updates, data entry, etc.) for projects in Productions Status are continually backed to facilitate PITR (point in time recovery) methods and are stored for approximately 30 days. Access to the data and various systems are protected by WUSTL Key and password authentication in accordance with our University’s HIPAA policy."

Example with Additional Technical and Security Details (often required for sensitive or controlled data):  

"Each REDCap consortium member institution hosts its own separate and independent REDCap server instance.  The Institute for Informatics, Data Science, and Biostatistics (I2DB) hosts the WUSTL REDCap instance and maintains servers where REDCap data and metadata are stored.  Data stored in the WUSTL REDCap instance in Production Status are protected by multiple layers of security, running on Linux platforms configured for strict user permission policies. Our REDCap database is hosted on scalable cloud based services hosted in the WUSM secure network. User access is provided via an external secure web server.  All web communication between the user web browser and the web server is SSL encrypted. Further protections are provided via strict Linux permission configurations on the servers themselves. All database transactions for projects in Productions Status are continually backed to facilitate PITR (point in time recovery) methods and are stored for approximately 30 days. Uploaded files are stored on secure cloud services and are only accessible via the WUSM secure network. Access to the data and various systems are protected by WUSTL Key and password authentication in accordance with our University’s HIPAA policy."


Grant Acknowledgements

The Washington University instance of REDCap receives funding support from the Siteman Cancer Center (SCC) and the Institute of Clinical and Translational Sciences (ICTS).  REDCap is considered a core service of both SCC and ICTS that require reporting of usage and impact at regular intervals.  Technical support, user policies, and training for REDCap is provided the Institute for Informatics, Data Science, and Biostatistics (I2DB) Informatics Core Services (ICS) and Bernard Becker Medical Library Data Management and Sharing Services.  To help ensure the continued funding of the Washington University instance of REDCap and REDCap support services, please use the text below in publications and other appropriate research outputs to acknowledge the grants that fund SCC and ICTS as well as support services provided by I2DB and Becker Library.

“The authors wish to acknowledge the Siteman Comprehensive Cancer Center and National Cancer Institute (NCI) Cancer Center Support Grant P30 CA091842, the Washington University Institute of Clinical and Translational Sciences Grant UL1TR002345 from the National Center for Advancing Translational Sciences (NCATS), and the I2DB and Becker Library REDCap Support teams for supporting the Washington University instance of REDCap (Research Electronic Data Capture). NCI and NCATS are part of the National Institutes of Health (NIH).“


Citations of REDCap and REDCap Consortium Publications

:

P.A. Harris, R. Thielke, R. Taylor, J. Payne, N. Gonzalez, J.G. Conde. Research Electronic Data Capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377-81. [doi: 10.1016/j.jbi.2008.08.010].

PA Harris, R Taylor, BL Minor, V Elliott, M Fernandez, L O’Neal, L McLeod, G Delacqua, F Delacqua, J Kirby, SN Duda, REDCap Consortium,The REDCap consortium: Building an international community of software partnersJ Biomed Inform. 2019 May 9 [doi: 10.1016/j.jbi.2019.103208]



2.0 User Account Issues

2.1 - I have a REDCap account. Why don’t I have access to any databases?

You only have access to databases that you create and other databases to which you have been given access.  If there is a database that you need to use, contact the PI or REDCap Project Administrator with your REDCap user name.  

2.2 - I’ve switched departments. Do I need a different REDCap account?

No, you can use your existing REDCap account on any database to which you have access.

2.3 - Can non-Washington University personnel get REDCap accounts?

Yes, provided they are collaborating on a Washington University project or a project of a WU affiliate. Users from external sites must receive a Guest WUSTL Key and Password.  In order for an external collaborator to receive a guest WUSTL Key, a Wash U "Sponsor" will need to complete the WUSTL Key Guest Account Request Form.  This form needs to be completed for EVERY external collaborator, not one form per site.  The "Sponsor" can be the project Principal Investigator (PI) or Project Administrator (PA).

2.4 - I am having issues with my log in credentials (WUSTL Key and Password).  Can REDCap Support help?

Access to your REDCap account is authenticated with your WUSTL Key and Password which is managed by WashU IT.  Please refer to WU IT's WUSTL Connect Guides in order to troubleshoot issues with your WUSTL Key and password.

3.0 Study Development

3.01 - REDCap Best Practices for Data Collection of Clinical Trials

(See linked page)

3.02 - What are the steps for creating a REDCap database for my research?

First, log in to REDCap with your WUSTL Key and password. Next, view the relevant video tutorials to learn about database creation, variable types, branching logic, item validation, and other REDCap features. (The videos can be viewed without an account.)  After you receive your account, create preliminary versions of your forms on the Demo server*, test them, and refine them.  When you are satisfied that your forms are ready to use, apply for a REDCap project account if you do not already have one.  When the project account has been created, move the database to the Production server and do more testing, this time with real data.  Put the database into production status when appropriate.  At this point you have the option of retaining the existing data or erasing it.

*Note: Users with database-creation privileges on the Production server, whether based on the current project or a previous one, have the option of creating and developing their project on the Production server rather than the Demo server. This saves the step of moving the project from the Demo to the Production server. Developing the project on the Production server is especially helpful when the project is a longitudinal one or involves surveys. Both of these require customization that must be done on the Production server.

3.34 - Do Quality Improvement Projects need IRB approval?

HRPO's recommendation is for Quality Improvement project researchers to contact Mitchell Shawn Saulisbury-Robertson who is the Expedited Review Manager and request a determination on what approval is needed for their data collection. Determinations are made on a case by case basis. 

Name: Mitchell Saulisbury-Robertson

Address: Campus Box 8089

Phone: (314) 747-7022 

Title: HRPO Expedited Review Manager

Department: Human Research Protection Office

Email: m.saulisbury-robertson@wustl.edu

3.05 - Who can create projects on REDCap?

Anyone with a WUSTL Key and Password that has logged into REDCap can create projects.  By default, projects are in development mode when created.

3.06 - How do I move to Production Status?

Go to Project Setup, scroll to the bottom of the page, select Move to Production.  If your project is not in Research or Operational Support, you will be asked to switch the status. You will be required to upload your IRB approval or waiver letter.

3.08 - When should I put my database into Production Status?

Databases can only be put into production status on the Production server. Production status is not available on the Demo server.

Please do not rush to put the database into production status. Do sufficient testing to assure yourself that the database is ready for use. Test it yourself and have colleagues test it by making up and entering data. When you’ve got it running smoothly, move it to the Production server if it isn’t already there (a REDCap project account is needed for this.) If there are any made-up records in the database you can delete them and start entering real data. (There is an Erase All Data button on the Other Functionality page.) This is the true test of whether or not the database is ready for production. If the database passes your tests you can put it into production status, retaining the data that have been entered. If the database requires changes, you can make them and retain the existing data if appropriate or delete the data if it needs to be re-entered. After the database is in production status, changes may need to be approved by a REDCap Administrator before they take effect.

If you find you’ve put the database into production status too soon, you can ask the REDCap Administrators to move it back to development status. You can put it back into production when it’s ready.

3.10 - Where are the video tutorials located?

The latest versions of the tutorials can be found at the Video Tab within Resources on the REDCap Consortium website.

3.11 - Aside from the video tutorials, what REDCap educational materials are available?

Once you have your account you can read the REDCap Help & FAQ page.  There is a tab to it on most REDCap screens.  There are resources available within this PDF: REDCap. The REDCap pdf WUSTL REDCap Training and Support.pdf has links to several REDCap User Group presentations and resources.

There is also a free online training course developed by Vanderbilt and offered through Coursera (course:Clinical Data Management)

3.12 - What is the difference between the Demo server and the Production server?

The Demo server is used for getting acquainted with REDCap features and, optionally, creating and testing databases that will later be used for data entry on the Production server. Databases on the Demo server are not authorized for data collection. While the Production server can also be used for creating and testing databases, its main distinction is that databases can be put into production status and used to collect real data.

3.13 - How can I add a new choice to an existing radio or dropdown item without changing previously entered data?

It’s important to know that the choices in radio and dropdown items are displayed in the order in which they are found in the data dictionary. This isn’t necessarily numeric order.

Suppose you have a radio item with the choices:

      • 1,Adams
      • 2,Grant
      • 3,Jones
      • 4,Smith

and later want to add another choice, Clark, and also to keep the choices in alphabetical order. This is the way NOT to make the changes:

      • 1,Adams
      • 2,Clark
      • 3,Grant
      • 4,Jones
      • 5,Smith

If these changes are approved, existing data for Grant, Jones, and Smith will be corrupted. Records that were entered as Grant will belong to Clark, those that were entered as Jones will belong to Grant, and so on.

The new choice can be added without changing existing data in this way:

      • 1,Adams
      • 5,Clark
      • 2,Grant
      • 3,Jones
      • 4,Smith

The choices will still appear in alphabetical order and existing data will not be changed.

3.14 - How can I edit and format the text within my project?

Text formatting can be added to certain elements in your project using CSS styles and HTML tags.  
Examples include: 

 Field labels
 Section headings and descriptive text fields
 Survey welcome and thank-you messages
 Survey invitation emails

Basic HTML & CSS Formatting in REDCap

3.15 - How do I setup Twilio to send SMS text messages and voice calls?

REDCap has the capability to utilize a third party SMS and voice call service called Twilio for sending survey invitations via SMS text messages and also for having respondents take surveys via a voice call or SMS.  With this feature enabled, you can invite a participant to take a survey by sending them an SMS message or by calling them on their phone.  The participants can then take your surveys, either as a voice call survey or as an SMS message conversation.  The survey data would then be collected in REDCap directly from their phone without having to use the website.  
SETUP & CONFIGURATION:  Before you begin the setup steps below, you must:
1. Register and setup up your own Twilio account at www.twilio.com
2. Fund your account with some money using the Billing page in Twilio (since there is a cost for each phone call made and for each SMS message sent and
3. Purchase a phone number to be used for this REDCap project (see the Numbers page in Twilio).  Each project must have its own number.
Once you have a phone number setup in Twilio for your project, you will need to send an email to the REDCap administrator (redcap_helpdesk@wustl.edu) with the following information:

1. Twilio Phone Number
2. Twilio Auth Token
3. Twilio Account SID

(see the API Credentials section on the Twilio main Account Settings page)

Note: Please ensure you have DISABLED Twilio's 'Request Inspector' for this account:
A Twilio feature named Request Inspector causes all activity to be logged in detail and stored on Twilio's servers. For the highest level of privacy, it MUST BE DISABLED in your Twilio account in order to be able to utilize the Twilio services in REDCap. You will find this setting on the Configure page under 'Programmable Voice'

Once your receive a confirmation email back from your REDCap administrator that your project is connected to your Twilio account, you can then configure how you want to use Twilio in your project. In general, not much is different between administering a survey normally in REDCap than when using Twilio SMS/voice calls except that you additionally choose how your survey invitations are delivered. The following choices are available:

1. Initiate survey as voice call
2. Initiate survey as SMS conversation
3. Send survey invitation with survey link via SMS
4. Send survey invitation via SMS to take survey as voice call (respondent makes call)
5. Send survey invitation via SMS to take survey as voice call (respondent receives call when replying via SMS).
Any or all of these invitation delivery methods can be utilized within a single project. The choice of delivery method completely depends upon your specific use case for how you want to collect data from your participants.  It is NOT recommended to use option 

VOICE CALL SURVEYS: When participants take a survey as a voice call, questions are asked one at a time, in which the Twilio service will use text-to-speech technology to read the questions to the participant audibly on their phone. You may choose the language and/or dialect in which the text should be read. Participants will respond by entering numbers on their phone's keypad, thus only numeric responses can be used because of this limitation (this includes the use of integer/number fields and also multiple choice questions with numeric codings, in which the participant will enter the numeric coded value on their keypad, not the label that is read to them over the phone). For example, the question might be a Yes-No question, which might look like 'Do you like ice cream? Yes, press 1. No, press 0.', or a number question like 'What is your age?'.

SMS SURVEYS: When participants take an SMS survey, questions are asked one at a time as an SMS text message conversation/thread. SMS surveys provide more response possibilities than voice calls. While participants in voice calls can only respond with numbers, they may respond with any kind of alpha-numeric text for an SMS survey.
Note:  Only REDCap administrators are allowed to enable the Twilio option to initiate a survey as an SMS conversation. Much like email, SMS is not considered a secure form of communication, so you may not want to administer surveys as SMS conversations if the particpant will be submitting identifying information (PHI or PII) unless you have been granted special permission from the participant to do so. Given such sensitive privacy issues, only your local REDCap administrator can enable the optional setting to use SMS surveys. Please notify your administrator about this if you wish to have this option enabled.

COMPATIBILITY: Most of REDCap's survey features still function much the same when taking a survey via SMS or as a voice call. This includes the enforcement of required fields, field validation, branching logic, using the Survey Queue for multiple surveys (only works with Auto-Start enabled), survey email notifications and confirmations, the Participant List, Automated Survey Invitations, survey Stop Actions, and computer adaptive tests (CATs) downloaded from the REDCap Shared Library. One of the few survey features that is not compatible is the Survey Login feature.
COST: In order to use the Twilio SMS and Voice Call services in a REDCap project, you will have to connect your project to your Twilio account by entering your Twilio credentials into REDCap during the setup process. And as REDCap makes calls and/or sends SMS messages using this service, all charges to your Twilio account will be made based upon its usage. This is not done by REDCap but is done internally by Twilio as you use its services. In this way, no monetary transactions are made by REDCap, and thus it is your responsiblity to maintain the funds in your Twilio account in order to ensure that the service continues to work for your REDCap project. If your Twilio account runs out of funds, the Twilio services in REDCap will cease to function. For information on the cost of each call or each SMS message, visit your Twilio account to view the rates.
PRIVACY & SECURITY INFO: It is important to understand that this feature utilizes the third-party service Twilio.com, which means that all voice calls and SMS messages will be routed through Twilio's servers. However, REDCap goes to great length to ensure that voice call records and SMS transcriptions do not stay in Twilio's logs but are removed shortly after being completed. This is done for security and privacy concerns (e.g., HIPAA), in which your survey participants' phone numbers and their survey responses do not get permanently logged on Twilio's servers but instead remain securely in REDCap.
IRB COMPLIANCE:  All projects requiring IRB approval must report to the IRB that their project utilizes Trilio.

4.0 - Study Management

4.01 - What is the REDCap URL?

https://redcap.wustl.edu/

4.02 - I tried to give a user access to my database but REDCap says he cannot be granted access because he is not yet a REDCap user. What’s up with that?

This person must log in to REDCap at least one time before you are able to find their username on the User Rights application in order to grant them access to your project.. 


4.04 - I’ve created a REDCap database. How do I give others access to it?    

Select User Rights and begin typing their name or WUSTL Key.  Select the user when you see their name and WUSTL Key.  Select Add with Custom Rights.  Assign the necessary User Rights.     

4.05 - How do I delete a record?    

The ability to delete records exists in REDCap but is turned off by default.  A user with access to the User Rights page can turn it on.  When the Delete Record right is active, there will be a Delete Record button at the bottom of each form.  Deleting a record deletes all data for all forms for that ID for that arm of the database, not just the form on which the delete button is pressed.  We strongly suggest that it be turned on only when necessary and turned off again when not needed.


4.06 - I entered an ID incorrectly. How can I correct it?    

The ability to change record IDs exists in REDCap but is turned off by default.  A user with access to the User Rights page can turn it on.  We strongly suggest that it be turned on only when necessary and turned off again when not needed.  

4.10 -  How do I see the same summary of proposed data-dictionary changes that the REDCap Administrator sees?    

When making changes to the data dictionary of a project that is in production status, the user can see a summary of the changes along with REDCap’s evaluation of the changes. The is the summary that the REDCap administrators see when the changes need approval. It lists variables being added, deleted, and changed, and it also lists warnings when a change can lead to corruption or loss of data.

To see the summary when submitting changes, click the link “View detailed summary of all drafted changes.

4.11 - Will you give me access to a REDCap project?    

No. You need to contact the project’s Prinicipal Investigator, Project Administrator (PA), or other study team member to add you to the project.

4.12 -  How do I transfer my project to a new PI?    

This is best done while you are still at Washington University.

Have the incoming PI submit a new REDCap Project Account.

Give the incoming PI access to the project-associated REDCap databases.

Send an email to REDCap_Helpdesk@wustl.edu telling us the name and email address of the new PI and the exact names of the project-associated REDCap databases that will be transferred to the new PI.

If you leave the university without first transferring your REDCap project to a new PI we will have to check with HRPO to verify that the new PI is in charge of the project. The new PI still needs to submit a REDCap project-account application.

4.13 - How do I designate a different REDCap Project Administrator for my project?    

The PI should send an email to REDCap_Helpdesk@wustl.edu giving the name, email address, and REDCap user name of the new REDCap Project Administrator. In addition, the REDCap project ID (PID) number must be specified. The PID number is in the project’s URL when accessing the project. It is the string of digits following the string “pid=” . In the following example, the PID is 1647 :


4.14 - How do I enable a module?

         Users will request to have a module enabled for their project. To enable a module, navigate to      the project, scroll down on the left panel and select “Manage” near External Modules. From there, you can select a module to enable. Click “Enable a Module” and search for the module you are seeking to enable. 

4.15 - How do I view project logs?

Users with rights to view logs can select Logging from the left hand menu.  If you do not see Logging you do not have access to this application for this project.

4.16 - Can I receive a notification when someone completes a survey?

When a user wants a notification when a survey is completed, navigate to the project, then go to Alerts and Notifications. From there, they can customize the alert.

4.17 - How do I modify project arms?

Navigate to the project, navigate to project setup, navigate to Designate Instruments for My Events and begin editing.



5.0 - Data Export

5.01 - My REDCap data are not importing into SPSS correctly. What should I do??

SPSS is very sensitive to invalid data. The first thing to do is to run the Field Validation Errors (Incorrect Data Type) task in the Data Quality tool in the Applications section of your REDCap project. (This requires permission on the User Rights screen.) Correct any errors and try the export again.


Carriage Returns in text fields can also cause problems. Run an export that excludes non-validated text fields and try importing it into SPSS. If this import succeeds then there are problems in the text fields. Either edit the text data, deleting carriage returns, or exclude the fields from your exports.

Field names must begin with a letter.  If importing a field name the begins with an underscore you will need to rename the field in the SPSS syntax file before running the SPSS program.  Remember the SPSS CSV file does not contain the column names so only the SPSS syntax file needs to be edited.


If neither of these steps solve them problem, send a copy of the log generated from the import, along with a description of the problem and the steps you’ve taken to solve it, to REDCap_Helpdesk@wustl.edu.


6.0 - MyCap

6.01 - What is MyCap

MyCap is an extension to REDCap that lets researchers capture patient reported outcomes using a participant’s phone or tablet. MyCap is similar to REDCap surveys in that participants enter data which is then synchronized to the researcher’s REDCap project. REDCap surveys are administered through a web browser whereas MyCap “tasks” are administered through a custom designed mobile application for Android and iOS devices.

6.02 - MyCap Features

MyCap has many features in addition to capturing basic task data:

·         Offline access: Participants may complete tasks without internet connectivity. Data are stored in an encrypted database on the device and synchronized to REDCap when possible.

·         Active tasks: Some tasks utilize the device’s hardware sensors to capture steps taken, sound, images, video, heart rate, and more.

See http://researchkit.org/docs/docs/ActiveTasks/ActiveTasks.html for information on active tasks. 

·         Scheduling: Flexible scheduling for one-time tasks, repeating tasks, and permanent tasks. 

·         Reminders: Participants receive a notification on their device when a task is due.

·         Secure text messaging: Researchers may send a message to an individual participant or an announcement to all participants.

·         Customization: Researchers use the MyCap module within REDCap to define informational screens, specify contact information, choose a color scheme.

·         Security: The MyCap mobile app protects participant data by requiring a 6-digit passcode to unlock the app.

·         Multi-project support: A participant may join multiple projects on a single device.. 

6.03 - To Demo MyCap

1) Install MyCap from the Google Play Store or Apple App Store. Links are provided on https://projectmycap.org/.

2) Visit https://www.projectmycap.org/?demo

   Page 173 of 200 REDCap version 9.1.2 updated June 28, 2019

3) Scroll down to the bottom of the page and submit the “PUBLIC DEMO” form. You should see a QR code after submitting the form.

4) Open the MyCap mobile app and scan your QR code.

To request a new MyCap-enabled REDCap project or to ask any question regarding MyCap, please email mycap@vumc.org.


6.04 - To Setup a Wash U. Production MyCap Project

Contact the REDCap Administrator at REDCap_helpdesk@wustl.edu

6.05 - Difference between REDCap Mobile App and MyCap, consider this information


6.06 - MyCap Boilerplates

Technology Boilerplate for IRB Submissions

Patient level, clinician level, and clinic level data for [Change to represent your study] will be collected using MyCap and stored electronically in the REDCap platform.

MyCap makes it easy for researchers to capture participant/patient reported outcomes using mobile devices. REDCap is used to define tasks/instruments/surveys to be completed by participants. MyCap translates REDCap task metadata into a structure compatible with ResearchKit and ResearchStack. When a project participant completes a task, MyCap converts the results into a format compatible with REDCap before synchronizing back to the REDCap project.

MyCap App Security:

Participant data is stored locally on the device in an AES-256+SHA2 encrypted database. Data remains on the device if an internet connection is not available. Applies to both iOS and Android devices.

When an internet connection is available, data is transmitted to REDCap using a SSL connection. A hash-based message authentication code (HMAC) is used to verify the integrity of the data and to authenticate the sender.

Data is wiped from the device after the MyCap app verifies that data has been successfully transmitted. Note that there is an optional MyCap feature that lets a participant see some of the data s/he has entered for an individual task/instrument/survey. By default, data is wiped.

Authentication to Device:

Participants create a 6-digit PIN that is used to open the MyCap, this is in addition to the authentication already on their device. A participant can choose to disable the MyCap PIN feature.

Boilerplate for Consent Document

Risks: Participation in the research study using the MyCap App involves entering the data in a secure, encrypted environment.  No data entered can be intercepted and read using this method.  [If your study uses this feature: There is an optional MyCap feature that lets a participant see some of the information s/he has entered for an individual task/instrument/survey. When this is used, data remains on the device to provide visual feedback back to the research subject, by default, data is wiped.]

Cost for the Research Subject:  The MyCap App is free to download and use.

Benefits:  You will be able to participate in the research study using your own device at a time convenient to you.

How your information is stored:  Your information is stored locally on your device in an AES-256+SHA2 encrypted database. Information remains on the device if an internet connection is not available. Applies to both iOS and Android devices. When an internet connection is available, information is transmitted to REDCap using a SSL connection. A hash-based message authentication code (HMAC) is used to verify the integrity of the data and to authenticate the sender. Your information is wiped from the device after the MyCap app verifies that data has been successfully transmitted.

Upon consenting, you acknowledge that you will be receiving personal health and identifying questions to answer within the application