studentmicky/REDCap-PRO

REDCapPRO is an external module for REDCap that enables Patient Reported Outcomes in a manner that complies with regulatory stipulations.

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
  • REDCapPRO Project Menu
    • Home Tab
    • Manage Participants
    • Enroll
    • Register
    • Study Staff
    • Logs
  • REDCapPRO Control Center Menu
    • Projects
    • Participants
    • Staff
    • Logs
  • Action Tags

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.
4. Enroll: The study staff member then enrolls the participant in this particular REDCap project
5. Survey invitations can then be sent to the participant using REDCap survey distribution tools like normal. Participants will need to log in with their REDCapPRO username 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.

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
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
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

Project Settings

Setting	Type	Description	Default Value
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 (currently Study Contact Name must be defined for this to be presented to participants)	N/A
Study Contact Phone	Phone	Phone number that participants should contact (currently Study Contact Name must be defined for this to be presented to participants)	N/A

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. Only DAGs available to the REDCap User are available as options to switch to	Normal User
Reset Password	Action	Sends an email to the participant which contains a password reset link	Monitor
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. This tab is available to Normal Users and above.

Register

This tab allows a user to register a participant with REDCapPRO. It is available to Normal Users and above.

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)

Logs

This tab allows Managers to view the logs of REDCapPRO relevant to this study project. It only contains information about actions taken in this project or on surveys tied to this project.

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
Change Email	Updates the email address in the REDCapPRO database for this participant

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.

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