eConsent Study Settings
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The study settings tab allows configuring the main study details. The tab contains the following sub-tabs:
- Personal details fields
Below we will go into detail about each sub-tab's options.
- Study logo: To include your study logo, please upload a .png or .jpeg file that has a height between 30 and a minimum width 40 pixels. To remove the logo, click on the ‘Clear’ button.
- Study status: This field displays the study status information. A study goes through the following statuses: Testing (Castor), Testing (Customer), Live. To learn more about what each status means, read the article ‘Study status’.
- Name of the study: The title of your study.
- Study description: Description of the study. The study description will be displayed to patients in Castor eConsent.
- 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 available to patients in Castor eConsent.
By accessing the 'Configurations' tab, you are able to define properties related to consent, screening and subject ID's for your study.
The ‘Consent options’ section allows to enable the following features:
- Enable video calling for ICF signing: This will activate the possibility to perform a video call.
- Lock ICF by default: When the ICF is locked by default, it will first have to be unlocked by a study team member to allow for the participant to sign. To enable or disable these features, check the checkbox accordingly and click the button ‘Save changes’ to apply the changes.
In-person signing: This features allows signing of the consent forms in-person.
- The in-person signing process is started by the user that is conducting the consent procedure by selecting the ‘Sign in-person’ ICF option from the subject.
- The study team member that is conducting the consent procedure first has to confirm the subject's identity before the in-person signing could kick off. This identity confirmation step is logged in the audit trail.
- When handing over the device to the subject, the subject can directly sign the ICF without having to create an eConsent account.
Subject eligibility can be captured in eConsent using the 'Screening options' section.
- A study setting ‘Eligibility field’ allows the collection of your subject eligibility status (available statuses are: pending, pass, and fail) including the timestamp of when this was updated.
The eligibility status can be updated manually, or automatically based on the outcome of a screening survey that is filled in by the subject.
Screening and Subject ID's
It is possible to configure screening ID and subject ID for your study.
- eConsent automatically creates your screening ID’s. You can make changes to the automatic sequence or change to manual set up until your study goes live.
- To configure the Screening ID's, click on the 'Change configuration' button, set the field 'Set up automatic eConsent screening ID sequence?' to 'Yes' and define how the ID's should be configured.
- Site abbreviation, a separator, and the number of digits are configurable when enabling automatic screening ID generation. When this feature is enabled, no manual entry of screening ID’s is allowed.
- Click on 'Set screening ID' button to save the changes:
- A study setting to let eConsent automatically generate screening ID’s is added. Site abbreviation, a separator, and the number of digits are configurable when enabling automatic screening ID generation. When this feature is enabled, no manual entry of screening ID’s is allowed.
- It is possible to copy over the screening ID into the subject ID is for studies that do not make a distinction between these two identifiers by setting the field 'Would you like to automatically copy your screening ID to use as your subject ID?' to 'Yes'.
Personal details fields
Additional personal details of the subjects can be collected. Data to be collected can be configured in the section 'Personal details fields'. This data is collected on a per study level, and subjects will be prompted to fill in the data. Study team members can also add and edit this information.
- The following subject information can be collected: Name, Date of birth, Gender, Phone number, Address.
- When opening the study as a subject, and there are personal details requested, the subject is prompted to fill in and submit their data before continuing. Subjects can always review their submitted data via the ‘Study Profile’ tab.
- Changes concerning the subject's personal details are logged in the audit trail.