Castor eConsent  enables researchers and organizations to create and manage electronic informed consent forms for their studies. Before you can start using eConsent, you will need to be granted access and have an admin account created for you. 

This video and the article will guide you through the necessary steps to get started with Castor eConsent.

Below is a general overview of all the steps required to set up your eConsent study.

Step 1. Account creation

To begin using Castor eConsent, you must first obtain access. Once you have signed the service agreement, contact the Castor support team (support@castoredc.com) and express your interest in using eConsent. In your request, please provide the following information needed to set up your admin account in Castor eConsent:

• Organization Name: Provide the name of your organization or institution. This ensures that your study is properly associated with your entity.
• Email Address for the Admin Account: Specify the email address that will be associated with the admin account in Castor eConsent. Ensure that this email address is accessible and will be actively monitored by the person responsible for managing the eConsent process.
• Country: Indicate the country where your organization is located. This information is essential for regulatory compliance purposes.
• Region for Information Storage: Choose the region where you would like your eConsent data to be stored. Castor offers options for data storage in the European Union (EU) or the United States (US). Consider any data protection or residency requirements when making this selection.
• Integration with Landing Page or Enrollment Portal: Inform Castor if you plan to integrate eConsent with a landing page or enrollment portal. This allows for a seamless participant experience and streamlines the enrollment process.

Step 2. Completing account creation

You will receive an email from us containing a link. This link will allow you to complete your account creation and log in to eConsent.

Step 3. Building and configuring the study

Once you are logged in, you can create a study by clicking on the “Create new study” button and then begin configuring it:

The following helpdesk articles will assist you as you configure your study and build your consent forms:

• Study Settings
• Org & Sites
• Users & roles
• Consent Forms

Additional eConsent content can be found on our helpdesk or by visiting Castor Academy.

Castor CDMS and eConsent workflows

Castor offers four standard workflow options depending on study requirements:

• Consent Standalone: Participants provide their informed consent electronically using this workflow.
• Screening (ePRO) --> eConsent: Participants complete a screening process with electronic patient-reported outcome (ePRO) before moving on to the eConsent process.
• eConsent --> Data Capture: Participants go through the eConsent process first and then data capture activities occur, such as filling out surveys or other data collection forms.
• Screening (ePRO) --> eConsent --> Data Capture: In this workflow, a participant first completes screening with ePRO, followed by the eConsent process in case they are eligible, and concludes with data capture activities.

If Castor is creating a landing page for participant recruitment, collaborate with your Project Manager to ensure a seamless integration between the landing page and eConsent process for a better participant experience.

Before requesting integration between Castor CMDS and eConsent products, make sure you have built both your CMDS and eConsent studies. Additionally, a signed service agreement is required for the integration process.

If none of the standard workflows suit your study requirements, custom development may be needed. Contact your account manager to discuss your specific needs and obtain a custom development quote.

Any other workflows not presented here will require custom development. Please contact your Account Manager for a quote.
 

Step 4. Setting your eConsent Study Live and Submitting a request for integration

If you are integrating eConsent with any other Castor products, please ensure that the integration is complete and tested before setting your study live.
 

Option 1: eConsent Standalone

If you have eConsent Standalone (Option1) please follow the below instructions:

After your study has passed your quality checks and UAT, you can set your study ‘Live’. All the participant records that were created during 'Testing' are automatically archived. Audit trail events during this study status are marked with the status 'Live'.

Only an Organization admin can set a study live.

Option 2: Screening Survey (ePRO) + eConsent

If you wish to (pre)screen participants before they consent and allow participant creation in CDMS automatically, you can only do so by using a browser based participant survey sent via ePRO. Integration functionality is not possible using Castor Connect.

In eConsent, select ‘Eligibility field’ as a Screening Option in your study’s settings.

In CDMS, please also include an eligibility calculation in your survey. The outcome of this calculation will toggle the ‘Eligibility field’ in eConsent for the creation and sending of an informed consent form automatically from eConsent.

After you have built your Informed Consent Form in eConsent and your Pre-screening survey in CDMS, please send the following details to ec-requests@castoredc.com :

• eConsent URL - Visible when you are logged in eConsent and on the Study Settings tab
• CDMS - server region of your study
• CDMS - Study ID
• CDMS - Name of the Survey Package that contains pre-screening survey
• CDMS - Field variable name and value from pre-screening survey that indicates eligibility
• Sites (name and abbreviation) to integrate in eConsent and CDMS (requires that the sites are created in both products and identical)
• Your email address
• Your name

The Castor Technical Implementation team will access your CDMS study to create a user account, define the API user rights, enable API access, and verify/gather UIDs and variable names. Your eConsent study will be accessed to integrate the sites in both products and set the trigger for participant creation.
 

Option 3: eConsent + Data Capture (CDMS)

If you only want a participant record to be created in CDMS after the informed consent process, before they consent and allow participant creation in CDMS automatically, we can do so by triggering participant creation in CDMS with 1 of the 2 following triggers: 1) Participant signs ICF or 2) ICF is countersigned by study staff. All forms assigned to the participant must be signed in order for the participant record in CDMS to be created.

After you have built your Informed Consent Form in eConsent and your study for data capture in CDMS, please provide the following information by sending a request to ec-requests@castoredc.com:

• eConsent URL - Visible when you are logged in eConsent and on the Study Settings tab
• Trigger - Participant signs or Countersigned                        
• CDMS - server region
• CDMS - Study ID
• Sites (name and abbreviation) to integrate in  eConsent and CDMS (requires that the sites are created in both products and identical)                    

The Castor Technical Implementation team will access your CDMS study to create a user account, define the API user rights, enable API access, and verify/gather UIDs and variable names. Your eConsent study will be accessed to integrate the sites in both products and set the trigger for participant creation.
 

Option 4: Screening Survey (ePRO) + eConsent + Data Capture

You can prevent participant ID generation and Data Capture until a participant is first pre-screened AND then consented. This combines the functionality presented in Options 2 and 3. For this, you will have to build one eConsent study, two CDMS studies, one with a pre-screening survey, and another for Data Capture. Screening and Data Capture must be created in separate CDMS studies. The details for both CDMS studies are required.

Please provide the following information by sending a request to ec-requests@castoredc.com:

• eConsent URL - Visible when you are logged in eConsent and on the Study Settings tab                                        
• Trigger - Participant signs or Countersigned                        
• Screening CDMS - server region of your study
• Screening CDMS - Study ID
• Screening CDMS - Name of the Survey Package that contains pre-screening survey
• Screening CDMS - Field variable name and value from pre-screening survey that indicates eligibility
• Data Capture CDMS - Study ID
• Sites (name and abbreviation) to integrate in eConsent and both studies CDMS (requires that the sites are created in both products and identical)

The Castor Technical Implementation team will access your CDMS studies to create  user accounts, define the API user rights, enable API access, and verify/gather UIDs and variable names. Your eConsent study will be accessed to integrate the sites in both products and set the trigger for participant creation.