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eConsent study settings

Updated

 

The Study Settings tab is where you configure the main details of your study. It has three sub-tabs: 

  • General
  • Configurations
  • Personal details fields

General settings

General Settings covers the basic properties of the study. This is the tab you land on when you open the study.

  • Study Logo: Upload a PNG or JPEG at least 30 pixels high and 40 pixels wide. After uploading, you can select Clear to remove it and re-upload if needed.

  • Study Status: Shows where the study sits in its lifecycle: Testing, Customer, or Live: Study status in eConsent

  • Name of the Study: The study title.

  • Study Description: Shown to participants in eConsent.

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Contact settings

In the ‘Contact Settings’ section, you can add some general contact information for your study.

  • Main contact: This field allows you to add a main contact for your study team by selecting them from your list of study admins in the dropdown. The main contact is visible for study team members only.
  • Study contact information: This field allows adding some general contact information for your study. This information will be visible to patients in Castor eConsent when they log in and access your study.

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Configurations

By accessing the 'Configurations' tab, you can define properties related to consent, screening, and participant IDs for your study.

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Screening options

  • Eligibility field: Participant eligibility can be captured in eConsent using the eligibility field setting. Available statuses are pending, pass, and fail, each stored with the timestamp of its last update. Eligibility can be set manually or updated automatically from the outcome of a screening survey completed by the participant, if integrated with a CDMS.

Screening and Participant IDs

  • Screening IDs: eConsent can generate screening IDs automatically. You can change the sequence or switch to manual entry until the study goes live.

    • Select Change configuration, set Setup automatic eConsent screening ID sequence to Yes, then define the site abbreviation, separator, and number of digits. With automatic generation on, manual entry is not permitted. Select Set the screening ID to Yes.

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  • Participant IDs: If your study does not distinguish between the two identifiers, set Would you like to automatically copy your screening ID to use as your participant ID? to Yes. Participant IDs may be up to 40 characters.

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Consent options

The ‘Consent options’ section allows you to enable the following features:

  • Video calling for signing: Enables the embedded video call.

  • Lock-unlock signing process: A study team member must unlock the form before a participant can sign it.

  • In-person electronic signature: Allows the consent conversation and signature to happen on one device side-by-side. The study team member starts the process by selecting Sign In-Person on the participant's record and must confirm the participant's identity first. That identity confirmation is written to the audit trail. Once the device is handed over, the participant signs without needing an eConsent account of their own.

  • Allow for paper consenting: Lets study admins create paper ICFs and upload signed PDFs against them.

  • Allow participant to download copy of consent form pre-signature: When enabled, participants can download an unsigned copy of the consent form for their review prior to signing. When disabled, the download is restricted until a valid signature has been completed.

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Participant withdrawal settings

A study administrator can enable the Include reason for withdrawal setting, which can be turned on even after the study is live. When it is on, a reason must be given whenever a participant is withdrawn.

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An administrator configures the list of reasons an investigator can choose from:

  • To edit a default reason for withdrawal, simply place the cursor in the field and start editing the provided text.
  • To remove the reason for withdrawal click on the trash bin icon.
  • To add a reason for withdrawal click on the ‘+Add new option’.
  • To save or cancel changes use the relevant buttons - ‘Save changes’ or ‘Cancel’ - at the bottom

Investigators can also select Other and type a free-text reason. The reason is written to the audit trail.

Configurations

Three settings let you make contact details compulsory at the point a clinician creates a participant. Enable these where your study depends on being able to reach participants:

  • Mandate participant phone number capture at enrollment: When enabled, a participant cannot be created without a phone number. This requirement also applies when a participant is created for paper consent and a signed form is uploaded.

  • Require email address on participant creation: When enabled, a participant cannot be created without an email address.

  • Enable WeChat QR code generation for Chinese participants.

Personal details fields

Configure which additional participant details are collected. Data is collected per study, and participants are prompted to complete it before continuing. They can review it later under their study profile. Study team members can also enter and edit it.

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The following participant information can be collected:

  • Name
  • Date of birth
  • Gender
  • Phone number
  • Address

Where a site investigator has pre-filled a field on the participant's behalf, the participant is not blocked from continuing to sign. Changes to personal details are written to the audit trail.

 

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