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Study configuration includes all settings that control how your study operates, from basic metadata to advanced features.

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Study Status

Studies have three primary states:

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Changing Status

1

Review Configuration

Before activating, review all study settings, questionnaires, and pathways.
2

Navigate to Status

Go to Study Settings > Status.
3

Update Status

Select the new status. Confirm the change.
Moving from Active to Retired is permanent. Ensure all data collection is complete before retiring a study.

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General Settings

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Study Information

Configure sponsor information and study contacts for:
  • Official correspondence
  • Shipping addresses
  • Primary contact personnel

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Participant Settings

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Default Participant Status

Set the initial status for newly enrolled participants. Common options:

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CRF Signing Requirements

Configure whether CRF signing is required:
  • Enabled: Records require signature from authorized signers before finalization
  • Disabled: Records are finalized without signature requirement

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Site Settings

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Self-Registration

Configure site self-registration:

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Service Providers

Enable external service providers:
  • Central laboratories
  • Core facilities
  • Other centralized services
When enabled, sites can select from configured service providers during setup.

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Source Data Capture

Control whether site staff can upload source documents and get AI-suggested CRF values with Source Data Capture. The setting is off by default for every study.
1

Open Site Settings

Go to Study > Setup > Site Settings.
2

Toggle the Setting

Select or clear Enable source data capture in this study.
3

Confirm

Select Enable or Disable in the confirmation dialog. Select Cancel to leave the setting unchanged.
Only study team members with permission to manage sites can change the setting. Other users see it with the checkbox disabled. Once the study is active, you must put it into amendment before you can change the setting. Archived studies cannot be changed. Disabling the setting stops site staff from starting new extractions. Suggestions that already exist stay available to review, and values already applied stay in the participant records. Every change is recorded in the study audit trail.

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Data Settings

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Protected Health Information

Configure which PHI fields are collected. These settings affect all questionnaires that use PHI fields.

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Sensitive Data Handling

Configure handling of fields marked as sensitive:
  • Additional access controls
  • Audit logging for sensitive data access

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Feature Toggles

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Participant-Facing Elements

Enable elements visible to participants:
  • Participant-facing questionnaires
  • Self-reported outcomes

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Public Information Hub

Enable public-facing study information:
  • Public study page with general information
  • Recruitment materials and contact information

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Amendments

Active studies can be amended to update configuration:
1

Start Amendment

Go to Study Settings and click “Start Amendment”.
2

Make Changes

Modify study configuration as needed. Changes are tracked separately from the live study.
3

Review Changes

Review all pending changes before applying.
4

Apply Amendment

Apply the amendment to update the active study.
Some changes may require additional steps, such as migrating existing data or updating site configurations.

Study Arms

Configure treatment arms.

Public Info Hub

Set up public study information.