REDCapPRO - Patient Reported Outcomes

Table of Contents

• REDCapPRO - Patient Reported Outcomes
  • Overview
    • What is REDCapPRO?
    • How does it work?
    • What is the process like for participants?
  • Installation
  • EM Settings
    • System Settings
    • Project Settings
    • Translation
  • REDCapPRO Project Menu
    • Home Tab
    • Manage Participants
    • Enroll
    • Register
    • Study Staff
    • Settings
    • Logs
  • Self-Registration
  • REDCapPRO Control Center Menu
    • Projects
    • Participants
    • Staff
    • Logs
  • API
    • Register Participants
    • Enroll Participants
  • Action Tags
  • Changelog

Overview

What is REDCapPRO?

REDCapPRO is an external module for REDCap that allows participants/patients to directly report study data (i.e., ePRO). Its primary purpose is to allow the identification of a survey participant and to log that information in a REDCap project's audit trail in a manner compliant with regulatory stipulations (primarily FDA's 21 CFR Part 11). The reason this is needed is that there is no built-in REDCap feature that provides all of the following:

1. Identification: It identifies the survey respondent (via a participant ID) in the logs of the project itself.

2. Authentication: It provides a means of proving that the participant is genuinely who they claim to be. There is no way for another person to pretend to be the participant, either in real time or after the fact by modifying logs. Obvious exceptions:

   1. Malicious attacks outside of REDCapPRO (e.g., intercepting a participant's password reset email by hacking their email account)
   2. REDCap admin or other IT professional directly modifying the database

3. Authorization: It provides a means of preventing unauthorized users from viewing identifying information and taking other unauthorized actions.

4. Convenience: It must be easy to use for REDCap admins, REDCap users, and study participants.

To achieve this, project users must first register a participant with REDCapPRO and then enroll that participant in the REDCap project. Step-by-step instructions are provided below.

REDCapPRO is not meant to replace any of the following features/modules/external modules:

• Survey Login
• Participant Identifier
• REDCap Mobile App
• MyCap
• REDCap Survey Auth

How does it work?

REDCapPRO provides a means for study participants to log in to REDCap surveys using a username created by REDCapPRO and a password that they choose for themselves. This password is not known to any other person (including study staff and REDCap admins).

These are the steps required to collect data using REDCapPRO:

1. Enable the module in the REDCap system
2. Enable the module in a REDCap project
3. Register: A staff member of the study registers a participant with REDCapPRO
   • The participant is registered system-wide. They use the same username and password for all REDCapPRO surveys in this REDCap system regardless of which REDCap project the survey belongs to.
   • Note: as of REDCapPRO 2.1.0, the option exists for participants to register themselves. See the Self-Registration section below for more information.
4. Enroll: The study staff member then enrolls the participant in this particular REDCap project
   • Note: as of REDCapPRO 2.1.0, the option exists for participants to enroll themselves. See the Self-Registration section below for more information.
5. Survey invitations can then be sent to the participant using REDCap survey distribution tools like normal. Participants will be required to log in with their REDCapPRO username (or email address) and password to access the survey. Because the login credentials are not tied to a specific record, public surveys are compatible with REDCapPRO.

What is the process like for participants?

• Upon registration with REDCapPRO, the participant will receive an email with a link to set their password.
• When the participant clicks a link to start a survey in a REDCapPRO project, they will see a login screen and will need to supply their username and password.
• They have the option to be sent a password reset email, a username reminder email, and/or an email address reminder email from the login screen.

• If multifactor authentication is enabled in the project, they will also be required to provide a security token after successfully logging in with their username and password. This token can either be sent to their email address or generated by an authenticator app like Google Authenticator or Microsoft Authenticator.

If authenticator apps are enabled for MFA, users will have a choice of MFA method

If email is chosen as the MFA method, users will receive an email with a security code

If an authenticator app is chosen for the MFA method, users will be prompted to enter a code from their authenticator app

Installation

• This External Module should be installed via the REDCapREPO
• It may also be installed by unpacking the code into the modules directory on your REDCap web server.

EM Settings

These are settings/configuration options accessible in the normal External Module settings interface.

System Settings

Setting	Type	Description	Default Value
Language File	Dropdown	The language that participant-facing text in the module will appear in. This system setting can be overridden by the corresponding project setting. See the Translation section below for more information.	English
Email From Address	Email	This will be the From email address for all system emails. This can help if emails are being sent to spam or are not delivered.	noreply@REDCapPRO.com
Prevent Email Login	Checkbox	Should participants be prevented from using their email address to log in to the system. Checking this will require that they login using their participant username only. Note: if checked, this overrides the associated project-level setting.	Unchecked
Warning Time	Number	Number of minutes to wait before warning participant of inactivity timeout	1 minute
Timeout Time	Number	Number of minutes to wait before logging participant out due to inactivity	5 minutes
Allow Project-Level Timeout Time Override	Checkbox	Allow a project-level timeout time to be defined and override system timeout time setting	Unchecked
Password Length	Integer	Minimum length of participant's password in characters	8 characters
Login Attempts	Integer	Number of consecutive failed login attempts before being locked out	3 attempts
Lockout Duration	Integer	Length of a lockout due to failed login attempts, in seconds	300 seconds
Multi-Factor Authentication	Checkbox	Require participants to use multi-factor authentication when logging in. This requires participants to enter a code sent to their email address in addition to their password.	Unchecked
Multi-Factor Authentication with Authenticator App	Checkbox	Allow participants to use an authenticator app (like Google Authenticator or Microsoft Authenticator) to generate a security code for multi-factor authentication. If unchecked, participants will only be able to receive a security code via email.	Unchecked
Restrict Multi-Factor Authentication project settings to REDCap administrators	Checkbox	If checked, only REDCap administrators will be able to access the multi-factor authentication settings in the project. If unchecked, any REDCapPRO manager will be able to access the multi-factor authentication settings.	Unchecked
Allow Self-Registration	Checkbox	Allow participants to register themselves with REDCapPRO. If checked, a link will appear on the login page that will take the participant to a registration page.	Unchecked
Restrict Self-Registration project settings to REDCap administrators	Checkbox	If checked, only REDCap administrators will be able to access the self-registration settings in the project. If unchecked, any REDCapPRO manager will be able to access the self-registration settings.	Unchecked
Allow Auto-Enroll Upon Self-Registration	Checkbox	Allow participants to enroll themselves in a project when they register. If checked, the participant will be automatically enrolled in the REDCapPRO project when they self-register	Unchecked
reCaptcha Site Key	Text	The site key for the reCaptcha v3 service. This is used to prevent bots from registering. Note: You cannot use the same site key as the one utilized by REDCap on surveys, because that site key is a v2 key.	(blank)
reCaptcha Secret Key	Text	The secret key for the reCaptcha v3 service. This is used to prevent bots from registering. Note: You cannot use the same secret key as the one utilized by REDCap on surveys, because that secret key is a v2 key.	(blank)
Enable the API	Checkbox	Enable the API for this system. This allows you to register and enroll participants using the API.	Unchecked
Restrict API project settings to REDCap administrators	Checkbox	If checked, only REDCap administrators will be able to access the API settings in the project. If unchecked, any REDCapPRO manager will be able to access the API settings.	Unchecked

Project Settings

Project configuration is done within the project's REDCapPRO menu.

Translation

This external module makes use of the built-in text translation functions in REDCap's External Module framework. These functions use .ini files (located in the lang directory of this module's source code) to replace placeholder text with the equivalent translated text.

If the language you desire does not appear in the Language File dropdown in the the external module settings, then no .ini file has been created for that language. Feel free to supply a translation file in whichever language you need. See the current language files located in the lang directory as guides. Feel free to open a pull request or send the file directly to andrew dot poppe at yale dot edu.

Note: Currently the module only translates participant-facing pages. Work is underway to translate all module pages.

REDCapPRO Project Menu

The REDCapPRO Project Menu is accessible via a link in the Applications section of the REDCap project side menu. Access to the different sections of the menu is restricted based on the role of the user (see the Study Staff tab description for details). The link to the menu itself is only visible to users or role Monitor or above, although the Home tab is accessible by anyone.

Home Tab

This is an informational page. This tab is accessible by any role (including no access).

Manage Participants

This tab allows a user to view enrolled participants in this study project and to take various actions on study participants. The actions available and the information that is visible depends on the role of the user. The tab itself is available to Monitors and above.

Label	Type	Description	Minimum Role to view/use
Username	Column	Contains the REDCapPRO username assigned to this participant	Monitor
First Name	Column	Contains the first name of this participant	Normal User
Last Name	Column	Contains the last name of this participant	Normal User
Email	Column	Contains the email address of this participant	Normal User
Data Access Group	Column	Contains the DAG the participant is currently in Note that this is independent of which DAG a REDCap record that corresponds with this participant might be assigned to	Monitor
Data Access Group	Action	Ability to reassign DAG. The user must not be assigned to a DAG in order to reassign DAGs, much like changing a record's DAG in REDCap. (Prior to version 1.0.0, DAGs in REDCapPRO worked differently)	Normal User
Reset Password	Action	Sends an email to the participant which contains a password reset link	Monitor
Change Name	Action	Updates the name in the REDCapPRO database for this participant	Manager
Change Email	Action	Updates the email address in the REDCapPRO database for this participant	Manager
Disenroll	Action	Removes the participant from this study project	Normal User

Enroll

This tab allows a user to search for a registered participant in order to enroll them into this study project. Users can set the participant's Data Access Group at this time as well, if applicable. This tab is available to Normal Users and above.

You can enroll many participants at once by importing a CSV file. The file must be formatted with the following columns. Note: the participants must already be registered with REDCapPRO before they can be enrolled in a project.

Column name	Description	Possible values	Required	Notes
username	REDCapPRO username of the participant	Any text	Required	Either this column or the email column must be present in the import file. NOT BOTH
email	Email address of the participant	Valid email	Required	Either this column or the username column must be present in the import file. NOT BOTH
dag	Data Access Group to enroll the participant into	Integer value representing the Data Access Group ID number	Optional	This value can be found on the DAGs page in the project. The usual DAG rules apply, so you can only assign a participant to a DAG if that DAG exists in the project. If you are assigned to a DAG yourself, you can only assign participants to that DAG. If you are not assigned to a DAG, you can assign the participant to any DAG.

You can also register (and optionally enroll) many participants at once by importing a CSV file on the Register tab.

Register

This tab allows a user to register a participant with REDCapPRO. Users also have the option to enroll at the same time as registering. They can set the participant's Data Access Group at this time as well, if applicable. This tab is available to Normal Users and above.

You can also register (and optionally enroll) many participants at once by importing a CSV file. The file must be formatted with the following columns.

Column name	Description	Possible values	Required	Notes
fname	First name of the participant	Any text	Required
lname	Last name of the participant	Any text	Required
email	Email address of the participant	Valid email	Required	The email address must not match the email address of a registered participant. If so, you will receive an error message and the import will be cancelled.
enroll	Whether or not to enroll the participant into this study once they are registered	Y to enroll <Blank> not to enroll	Optional	You can omit the column entirely if you do not want to enroll any of the newly registered participants.
dag	Data Access Group to enroll the participant into	Integer value representing the Data Access Group ID number	Optional	This value can be found on the DAGs page in the project. If enroll is not "Y" for a row, then the DAG value is ignored for that row. The usual DAG rules apply, so you can only assign a participant to a DAG if that DAG exists in the project. If you are assigned to a DAG yourself, you can only assign participants to that DAG. If you are not assigned to a DAG, you can assign the participant to any DAG.

Note: The column names are case-sensitive. The order of the columns does not matter.

Note: If you are using Excel to create the CSV file, you will need to save the file as a CSV file in order for REDCap to recognize it as such.

Study Staff

This tab allows Managers to set the role of users in the study project. All REDCap users are shown in this table. Set the role of the user according to this guide:

Role	Description
No Access	No access to REDCapPRO is given to this user.
Monitor	Basic access. Can only view usernames and dags and can only initiate password resets.
Normal User	Able to view participant identifying information and take several participant management actions (see Manage Participants section above).
Manager	Highest permissions. Has the ability to grant/revoke staff access and change a participant's email address

Note: REDCap administrators have full Manager permissions in REDCapPRO no matter what role they have in the project (or if they appear in the staff list at all)

Settings

This tab contains some project-level configuration options. This tab is only accessible by managers.

Setting	Type	Description	Default Value
Language	Dropdown	The language that participant-facing text in the module will appear in. This overrides the default system setting. See the Translation section for more information.	English
Prevent Email Login	Checkbox	If checked, this prevents participants from using their email address to log in to surveys. Instead, they must use their REDCapPRO username to log in. If email logins are prevented at the system level, this setting will not appear in the project setttings tab.	Unchecked
Timeout Time	Positive Integer	Number of minutes to wait before logging participant out due to inactivity. This overrides the default system setting, but it is only shown if enabled at the system level.	(blank) - defaults to system setting
Multifactor Authentication	Checkbox	Require participants to use multi-factor authentication when logging in. This requires participants to enter a code sent to their email address in addition to their password.	Unchecked
Allow MFA Authenticator App	Checkbox	Allow participants to use an authenticator app (like Google Authenticator or Microsoft Authenticator) to generate a security code for multi-factor authentication. If unchecked, participants will only be able to receive a security code via email.	Unchecked
API	Checkbox	Enable the API for this project. This allows you to register and enroll participants using the API.	Unchecked
Allow Self-Registration	Checkbox	Allow participants to register themselves with REDCapPRO. If checked, a link will appear on the login page that will take the participant to a registration page.	Unchecked
Auto-Enroll Upon Self-Registration	Checkbox	Participants will be automatically enrolled in this project when they self-register.	Unchecked
Email address to notify when new participants are auto-enrolled	Email	If auto-enroll is enabled, this email address will be notified when a participant self-registers and is auto-enrolled.	(blank)
Study Contact Name	Text	The name of the study staff member that study participants should contact with questions/problems. This will appear in emails sent to the participant	N/A
Study Contact Email	Email	Email address that participants should contact.	N/A
Study Contact Phone	Phone	Phone number that participants should contact.	N/A

Logs

This tab allows Managers to view and export the logs of REDCapPRO relevant to this study project. It only contains information about actions taken in this project, on surveys tied to this project, or certain actions taken regarding participants enrolled in this project. This tab is only accessible by Managers.

Self-Registration

As of REDCapPRO v2.1.0, the option exists to allow participants to register themselves with REDCapPRO. This is done by enabling the Allow Self-Registration option in both the system configuration and in the project settings. When this option is enabled, a "Don't have an account? Create one" link will appear on the login page that will take the participant to a registration page.

REDCapPRO Control Center Menu

This menu is accessible via a link in the External Modules section of the Control Center. Being in the Control Center, it is only accessible to REDCap administrators. It has the following sections:

Projects

This table shows all of the REDCap projects that currently have REDCapPRO enabled and some basic information about them.

Participants

This table lists all registered participants in the system. It lists every study project that each participant is enrolled in. It allows the following actions to be taken on a participant:

Action	Description
Reset Password	Sends an email to the participant which contains a password reset link
Update Name	Updates the name in the REDCapPRO database for this participant
Change Email	Updates the email address in the REDCapPRO database for this participant
Reactivate/Deactivate Account	A deactivated participant is unable to be enrolled in additional projects. However, they are still able to interact normally with projects to which they are already enrolled.

Staff

This table lists all REDCap users that have a role above No Access in any REDCapPRO study project. It lists all projects that each user has access to with a role of Monitor or above.

Logs

Similar to the project's Logs tab, this lists all logs made by REDCapPRO across the system.

API

This module provides an API for interacting with REDCapPRO. Using this API is similar to using the REDCap API. You must make a POST request to the API URL (The API URL is found on the project settings page.) The data must contain these three keys:

1. token: The REDCap API token
2. action: The action you want to perform (either register or enroll, see below)
3. data: A JSON encoded array of participants. Details about the format of the data are described below.

Register Participants

This method allows you to register participants with REDCapPRO.

• token: The REDCap API token
• action: register
• data: A JSON string which represents an array of participant objects. The data array can contain any number of participants. Each participant object must have the following:

Field name	Description	Possible values	Required	Notes
fname	First name of the participant	Any text	Required
lname	Last name of the participant	Any text	Required
email	Email address of the participant	Valid email	Required	The email address must not match the email address of a registered participant. If so, you will receive an error message and the import will be cancelled.
enroll	Whether or not to enroll the participant into this study once they are registered	Y to enroll Omit to not enroll	Optional
dag	Data Access Group to enroll the participant into	Integer value representing the Data Access Group ID number	Optional	This value can be found on the DAGs page in the project. If enroll is not "Y" for a participant, then the DAG value is ignored. The usual DAG rules apply, so you can only assign a participant to a DAG if that DAG exists in the project. If you are assigned to a DAG yourself, you can only assign participants to that DAG. If you are not assigned to a DAG, you can assign the participant to any DAG.

Note: The field names are case-sensitive. The order of the fields does not matter.

Enroll Participants

This method allows you to enroll already-registered participants into a REDCapPRO project.

• token: The REDCap API token
• action: enroll
• data: A JSON string which represents an array of participant objects. The data array can contain any number of participants. Each participant object must have the following:

Field name	Description	Possible values	Required	Notes
username	REDCapPRO username of the participant	Any text	Required	Either this field or the email field must be present in the import file. NOT BOTH
email	Email address of the participant	Valid email	Required	Either this field or the username field must be present in the import file. NOT BOTH
dag	Data Access Group to enroll the participant into	Integer value representing the Data Access Group ID number	Optional	This value can be found on the DAGs page in the project. The usual DAG rules apply, so you can only assign a participant to a DAG if that DAG exists in the project. If you are assigned to a DAG yourself, you can only assign participants to that DAG. If you are not assigned to a DAG, you can assign the participant to any DAG.

Action Tags

This module provides several action tags for populating REDCap fields with information about REDCapPRO participants. These are described below: Note: All action tags must exist on the same data collection instrument (not survey).

Action Tag	Use with field type	Validation on field type	Description
@RCPRO-USERNAME	text	none	This transforms the field into a dropdown selector. The user can select a participant and populate the field with that participant's username
@RCPRO-EMAIL	text	email	If @RCPRO-USERNAME is present on the instrument, then when it is selected the field with the @RCPRO-EMAIL tag will be populated with the participant's email address
@RCPRO-FNAME	text	none	Like @RCPRO-EMAIL, but the field will be populated with the participant's first name
@RCPRO-LNAME	text	none	Likewise, with last name

Changelog

Version	Release Date	Description
2.4.0	2023-12-01	Feature release - Release Notes
2.3.0	2023-11-28	Feature release - Release Notes
2.2.1	2023-11-20	Minor Change and Bug fix - Release Notes
2.2.0	2023-11-19	Feature release - Release Notes
2.1.3	2023-11-10	Minor Change to UI Text - Release Notes
2.1.2	2023-10-30	Major Bug fix - Release Notes
2.1.1	2023-10-27	Minor Bug fix - Release Notes
2.1.0	2023-10-10	Feature release - Release Notes
2.0.1	2023-10-09	Bug fix - Release Notes
2.0.0	2023-10-09	Major release - Release Notes
1.0.1	2022-04-01	Bug fix - Release Notes
1.0.0	2022-03-31	Change and bug fix - Release Notes
0.5.0	2022-03-30	Bug fix - Release Notes
0.4.9	2022-03-24	Minor bug fix - Release Notes
0.4.8	2022-02-23	Minor bug fix - Release Notes
0.4.7	2022-01-04	Minor bug fix - Release Notes
0.4.6	2021-12-14	Minor bug fix - Release Notes
0.4.5	2021-12-12	Medium security fix - Release Notes
0.4.4	2021-11-15	Improvement - Release Notes
0.4.3	2021-11-12	Improvement and minor bug fix - Release Notes
0.4.2	2021-11-04	Initial release