How do I export data of my study?

⚠️ Important: Always verify your export selection in the pop-up window before proceeding to ensure you're downloading the correct data set.

First, select the type of data you want to export.

• Subject-specific Data: Export subject-specific data in various formats. See below (2).
• Blank CRF (PDF): A blank CRF without any data, comments, or details.
• Annotated CRF (PDF): Provides detailed information about the study setup, including export labels, validations, and dependencies for each input field. Please note that there is no separate annotated PDF for the (S)AE module. (S)AE configurations are displayed in the generic aPDF.
• Settings (Excel): Exports comprehensive study configuration data including workflow settings, form structures, input field dependencies, and other setup parameters. This export provides a complete overview of how your study is configured.
• Randomization allocation list (Excel): Shows which randomization slots have been allocated, including information about when and by which collaborator each subject was randomized. 
  Read the following article to read further information about the premium feature "randomization": How to set up randomization (Step 4)
• System audit trail: Exports detailed logs of all setting activities and changes made within your study. This includes user actions, form modifications, configuration changes, and other system events for compliance and monitoring purposes. It does not include subject-specific audit trail logs. Read the following article on best practices on how to read the system audit trail: How to read the System Audit Trail export 

If you have chosen to export subject-specific data, you can select which subjects to include using the SICs dropdown menu. Choose from all subjects, multiple specific subjects, or a single subject as needed. 

Now choose the data you want to export and the desired data format. Depending on the selected data, the options of data format will adapt respectively.

The following data is available for subject-specific export:

1. Subject Information: Export subject information which mainly includes identification data (IDAT) including first name, last name, other identifying information, as well as the contact language. Choose your preferred export format: PDF, XLSX, or CSV.
2. Consent Data: Export (e)Consent information from the subject overview, including consent status per subject, and consent history. Choose your preferred export format: XLSX, or CSV.
3. Scheduled Events: Export data from planned study visits and scheduled assessments. Choose your preferred export format: PDF, XLSX, or CSV.
4. Unscheduled Events: Export data from unplanned visits and ad-hoc assessments that occurred outside the regular study schedule. Choose your preferred export format: XLSX, or CSV.
5. (S)AE Data: Export (serious) adverse events data including event details, outcomes, and reporting information. Choose your preferred export format: PDF, XLSX, or CSV. Select all or specific (S)AEs via the toggle button:
6. Query Data: Export data queries, responses, and query resolution history for quality assurance and data clarification purposes. Choose your preferred export format: XLSX, or CSV
7. Audit Trail: Export detailed logs of all subject-related changes, incl. data changes, triggered ePRO/notification/dependencies, or signature/locking activities for compliance and monitoring purposes. The subject audit trail is currently only available in PDF.
   ⚠️ Please note that you can only pull an audit trail export for each individual subject. If you would like to export the audit trail, please contact your Customer Success Manager. 

When selecting CSV format, you can also specify your preferred file delimiter.

When exporting as PDF, you can choose whether to include empty/unfilled fields of the input forms or display only completed fields.

XLSX format provides additional customization features:

• Consolidate tabs: Create a more compact version of your data by combining multiple forms into fewer sheets (see details below)
• Vertical table export: When your study uses tables in the EDC system, you can export them in vertical format. Then tables will appear in separate tabs, with each tab named according to the table's export label.

⭐ Consolidated tabs: Input forms that appear in multiple workflow steps (e.g., "Health Status" used in both Visit 2 and Visit 3) are combined into a single Excel sheet or CSV file, rather than creating separate tabs for each occurrence.

e.g. XLSX: 

⭐ Unconsolidated tabs: Each input form instance is exported to a separate Excel sheet or CSV file. For example, if "Health Status" appears in multiple workflow steps, each occurrence will create its own individual sheet/file (e.g., "Visite 2.1-Health Status", "Visite 3.1-Health Status").

e.g. XLSX

⭐  Good to know: The system automatically determines the download method based on the data selected. You'll either receive the file directly in your browser or via an email download link. 

⚠️ Important: Email download links automatically expire after 24 hours for security purposes. Make sure to download your file within this timeframe.

1. Main users:  How can I create, update, delete or export main users?