2.4.1 Events & Forms

Use Study Designer to create, configure, and manage Events and Forms for your study. These components define when data is collected and what information is captured for each participant.

Definitions

• Study Designer – The tool used to configure Events and Forms for your study.
• Event – A group of forms used to collect data during a specific point or activity in your study. Events may or may not correspond to real-world visits.
• Form or electronic Case Report Form (eCRF) – A structured collection of data fields used to capture participant information.

Examples

• An Event could represent a Follow-Up Visit or Early Termination.
• A Form might capture Vital Signs, Informed Consent, or Drug Accountability data.

Event Types

Each Event can be defined as one of the following:

Visit-Based Event

An Event linked to the study protocol schedule. Each visit has a defined timepoint and set of forms.
Example: Week 2, Week 6, or Monthly Follow-Up.

Common Event

An Event that can occur at any time in the study.
Example: Adverse Event (AE), Concomitant Medication (ConMed), or Early Termination.

💡 Tip: The appropriate icon appears next to the Event name.

Event Frequency

Both Visit-Based and Common Events can be configured as repeating or non-repeating.

Repeating Event

Occurs multiple times, either a known or unknown number of times.
Example: Adverse Events or Concomitant Medications.
💡 Tip: The repeating icon appears next to the Event name.

Non-Repeating Event

Occurs once per participant.
Example: Early Termination.

⚠️ Warning: After a study is published to Production, the following Event properties cannot be changed:

• You cannot change an Event from Visit-Based to Common (or vice versa).
• You cannot change an Event from Repeating to Non-Repeating.
• You can change a Non-Repeating Event to Repeating, but use caution—this may affect data collection and scheduling.

Calendar Configuration

Calendaring automates Event scheduling and notifications based on other Event statuses.
For more information on calendaring, refer to Basic Calendaring.

Manage Events

Use the Manage Events tools in Study Designer to add, edit, and configure Events in your study.

Add an Event

1. Click +Add an Event.
2. Enter a Name for the Event.
3. Click the Event name to open its details.
4. Complete the required fields.
5. Click Save.

💡 Tip: Choose clear, descriptive Event names (for example, Baseline Visit or Month 6 Follow-Up) to help users identify the Event easily in Study Runner.

Edit an Event

1. Click the Event Name to open the Event details.
2. Update settings as needed.
3. Click Save.

You can update the Event name directly in the name field.

• Changing the name updates how the Event appears in Study Runner.
• The Event OID (object identifier) does not change when the Event name is updated.

To edit the Event description:

1. Click Edit next to the Description field.
2. Add or update the description as needed.
3. Click Save.

ℹ️ Note: The Event description is optional. It can be displayed on the Participant Dashboard for Events used in Participate or eConsent.

Copy an Event

1. Click the Menu (⋮) next to the Event name.
2. Select Copy.

ℹ️ Note: Any updates you make to one Event are applied to its copy.

Archive an Event

Archiving removes the Event and all associated Forms from the study. Archived Events can be restored at any time.

1. Click the Menu (⋮) next to the Event name.
2. Select Archive.

Restore an Event

1. Click Archived Items in the header bar.
2. Click Restore next to the Event you want to restore.

Collaborate

Use the Collaborate feature to view and manage team members involved in study design. You can assign collaborators to specific Events.

To manage collaborators:

1. Click Collaborate in the Study Designer header.
2. View all members with design access.
3. Assign or remove collaborators from Events as needed.

Collaborators can comment directly on Events and Forms to streamline study design communication.

Members

Shows the users involved in designing the study who can be associated with specific Events.

Labels

Use Labels to visually group Events by color or text. Labels help organize Events but do not affect study behavior.
💡 Tip: Label Events that require review.
For more information on labels, refer to Design a Study – Labels.

Activity Log and Comments

The Activity Log tracks design actions related to Events, including:

• User
• Action performed
• Timestamp

You can also leave Comments to collaborate with other Study Designers.

For more information on activity log, refer to Design a Study – Activity Log.

Forms

Forms define the data collected during each Event.

You can create forms using either:

• Form Designer
• Form Template (XLS)

Form Designer

The Form Designer provides a drag-and-drop interface for building and editing forms.

1. Click the Form Card.
2. Click Design to open Form Designer.

For more information on form designer, refer to Using Form Designer.

Form Template

A pre-formatted spreadsheet (XLS) for defining form content.

Download the Form Template

1. In Study Designer, click Form Template in the header.
2. Save the XLS file locally.

💡 Tip: Always download the latest version before editing.

Upload a Form Definition

1. Click the Form name.
2. Click Upload to upload your XLS Form.
3. (Optional) Click Preview to test the form.

For more information on form template, refer to Using the Form Template.

💡 Tip: You can use both methods together, but formatting will differ when re-downloading an edited Form Template.

Manage Forms

Preview a Form

Click Preview on the Form Card to test form logic, calculations, and conditional fields.

If the form is configured for Participate, the button appears as Preview (as a Participant).

ℹ️ Note: Cross-form logic and Save/Complete actions are disabled in Preview mode.

Copy a Form to Another Event

1. Click the Form name.
2. Click the Menu (⋮).
3. Select Copy To.

Add a Form to an Event

1. Click + Add a form within the Event.
2. Search for the desired form.
3. Click + next to the form in the results.
   

You can add forms from:

• The current study
• The Form Library

Search for Forms from the Library

When you click + Add a form, a search field appears to locate forms stored in the Library.

As you type, matching Form Templates appear in a results panel.

The results panel includes:

• Results header
• Matching templates

If space is limited, the results panel may appear on either side or below the search field.

Clicking outside the search field or results panel closes the search interface.

Empty Search Results

If no matching templates are found, a message indicates that no templates match the search criteria.

Create a New Form from the Search Field

If a form does not exist in the results, you can add it as a new form.

Create the Form

1. Enter the desired form name.
2. Click the + button next to Add as a new form.

A new Form Card appears on the Study Designer board.

ℹ️ Notes:

• If the entered name matches an existing form, the Add as a new form button is disabled.
• If the form name is not already in use in the study, the button to add a new form becomes available.

Form Metadata in Search Results

Search results display metadata under the form name:

• Form version
• Created by (username)
• Last modified date

The metadata appears in the following format:

V.: (version_number) · (username):(last_modified_date)

Example: V.: 2 · AnnabelLee:20-Mar-2025

Form Collections

If a template belongs to a Form Collection, the collection name appears as a badge in the search results.

If no collection exists, no badge appears.

Form Template Labels

Labels assigned in the Library also appear in the search results.

If no labels exist, none are displayed.

Template Version Requirement

If a template does not have a defined version in the Library:

• The + button is disabled.
• The tooltip displays: “Cannot add form without a version.”

ℹ️ Note: Contact the administrator to add a version to the template so it can be used.

Preview a Form Template from Search Results

When you search for a form while adding a form to an Event, you can preview the template before adding it to your study.

Preview a Form Template

1. In the search results list, click anywhere on the form row except the + button.
2. A Form Preview overlay appears displaying the selected form template.

The preview displays the form layout and content using the same format as Form Designer Preview.

Close the Preview

1. Click outside the preview window to close it.
   Click the X in the upper-right corner of the preview window.
2. The overlay closes and returns you to the search results.

ℹ️ Note: Clicking the + button adds the form to the Event instead of opening the preview.

Forms from the Current Study

Forms already used in the study appear in search results with a label showing:

Study Name : Event Name

This helps identify where the form already exists.

Duplicate Form Restrictions

If a duplicate name exists:

• The + button is disabled.
• A tooltip indicates the form name is already in use.

Add a Current Study Form to Another Event

When adding a form from the same study:

• A copy of the Form Card is created.
• All versions are copied.
• Form properties must be configured separately.

Archive or Restore Forms and Form Versions

Use the Archive and Restore options to manage the availability of forms and form versions in your study.

Archiving a form removes it from its associated Event but keeps it available within the study. Archived forms are viewable but cannot be edited, and their data is excluded from extracts.

Archived forms appear in search results. They remain searchable even though they are not active on the board.

Archive a Form

1. Click the Menu (⋮) next to the form name.
2. Select Archive.

ℹ️ Note:

• Archiving a form removes it only from the selected Event. If the same form is used in multiple Events, those instances are unaffected.
• You must republish the study for archiving changes to take effect.

⚠️ Warning: If a Form Card is archived, you cannot add a Form Template from the Library to the Study Designer board with the same name as the archived form.

Restore a Form

1. Click Archived Items in the header.
2. Select Forms.
3. Click Restore next to the form you want to restore.

💡 Tip: Restoring a form returns it to its previous Event with all configurations intact.

Archive a Form Version

1. Click the Form Name.
2. Click the Version Options Menu (⋮) next to the version you want to archive.
3. Select Archive.

⚠️ Warning:
If the selected version is set as the default, the Archive option is unavailable.
To proceed, first select a different version as the default, or archive the entire form if it has only one version.

Restore a Form Version

1. Click Archived Items in the header.
2. Select Forms.
3. Click Restore next to the form version you want to restore.

Summary

Form properties can be edited on the form card.

Icon	Property	Description	Example
	Hide from Site Users	Form is hidden at the site level but accessible at the study level.	Used for forms with imported data or review forms.
	Required	Must be completed for the Event to be marked complete.	Consent Form must be signed.
–	Allow Add Another	Enables multiple form entries in a repeating Event.	Multiple ConMed entries.
	Participate Form	Allows participants to complete the form through OpenClinica Participate. For more information, refer to OpenClinica Participate.	Self-reported symptom diary.
	Public URL	Allows participant self-registration via a public link if OpenClinica Participate is enabled. For more information, refer to Configure Forms for Offline Mode and Public URL.	Social media recruitment.
	Offline Capable	Enables offline data entry through Participate. For more information, refer to Configure Forms for Offline Mode and Public URL.	Field research in remote areas.

💡 Tip: Use Permission Tags instead of Hide from Site Users for greater flexibility.

Source Data Verification (SDV)

Use Source Data Verification (SDV) to control which data items on a form must be verified against source documents. With Item-Level SDV, you can specify verification requirements for each individual item on a form.

When Item-Level SDV is enabled, each item on the form can be independently marked as Verified or Not Verified. If an item’s data changes, only that item becomes unverified—other verified items remain unaffected.

ℹ️ Note: Item-Level SDV is available for all forms created or first published after Stack 15 (December 2021).

Set SDV Requirements

1. Open the Form Card.
2. From the SDV dropdown, select Configure Item-Level SDV.
   • The Form Card displays the Item-Level SDV icon
3. Click Configure SDV.
4. Define SDV requirements for each field using the following options:
   • Not Applicable: items cannot be verified
   • Optional: items can be verified
   • Required: items must be verified for the form to be fully verified and get Verified status
5. The Form Card displays the Item-Level SDV icon. 

💡 Tip: If all items should have the same requirement, use the Update All To menu to apply a setting to all items at once.

Validation Rule

⚠️ Warning: When using Item-Level SDV, at least one item must be set to Required or Optional.
If all items are set to Not Applicable, change the form’s SDV Requirement to Not Applicable before publishing.

Form Drafts and Versions

Use Drafts and Versions to manage updates to your forms during study design. Drafts are unpublished, while Versions are finalized and published to Study Runner when you publish your study.

Overview

• Form Versions are the published, active forms included in your study.
• Form Drafts are editable forms created in Form Designer that are not yet part of a published study.
• Only Versions are pushed to Study Runner upon publication.

💡 Tip: Create and edit forms as Drafts during development, and promote them to Versions when ready to include in your study.

Upload and Manage Versions

When you upload a Form Template (XLS), the system automatically creates a Version that appears under Versions on the Form Card.

A Form Template must have at least one Version in the Library before it can be added to an Event. If no Version exists, the Form Template cannot be added to the Study Board.

You can upload new versions or overwrite existing ones:

• If the version number on the Form Template matches an existing version, the system overwrites that version upon upload.
• If the version number is different, the system creates a new version automatically.

⚠️ Warning: Once a form has been published to Production, it cannot be overwritten. To make changes, create a new version instead.

Manage Drafts

When you create or edit a form in Form Designer and save it, it becomes a Draft. The most recent draft appears at the top of the list, labeled (latest).

Drafts:

• Do not create new versions
• Do not appear when you publish your study
• Do not appear in the Audit Log

Promote a Draft to a Version

To include a Draft in your published study:

1. Click the Menu (⋮) next to the draft you want to promote.
2. Select Add to Study.

This action converts the draft into a new version.

⚠️ Warning: To prevent a new form from overwriting an existing one:

• In Form Designer: Change the version number in the Layout & Settings panel.
• In the Form Template: Update the Form Version field on the template’s Settings tab.

Draft Actions

⚠️ Warning:
If you upload a Form Template, edit it in Form Designer, and then download it again, the spreadsheet format will differ from the original.

Version Actions

Fields to display on Participant Details Page (Optional)

When a form is part of a Common Event, you can choose which fields appear in the Common Event table on the Participant Details Page (PDP).

Configure Display Fields

1. Open the Form Card within the Common Event.
2. Click the Fields to Display on Participant Details Page dropdown.
3. Select the form items you want to display on the PDP.

💡 Tip: Choose key summary fields—such as status, date, or outcome—to help users quickly review important information without opening the full form.

Permission Tags

Use Permission Tags to control which User Roles can view or edit data from specific forms in Study Runner. Permission Tags provide flexible, form-level access control beyond role defaults.

Configure Permission Tags

To define or update Permission Tags, refer to Permission Tags.

Assign Permissions

To grant or modify user access for forms configured with Permission Tags, refer to User Access & Sharing.

💡 Tip: Use Permission Tags instead of hiding forms from site users for greater control and auditability.

Data Dictionary

The Data Dictionary provides detailed, form-specific metadata to help you understand each form’s structure and configuration.

You can access the Data Dictionary from each Form Card in Study Designer. It includes:

• Form Metadata – Form name, version, and properties

• Item Metadata – Item OID, Item Group Name, Item Group OID, Item Type, and Insight Table mappings

Export the Data Dictionary

1. Open the Form Card.

2. Click the Data Dictionary link.

3. Download the CSV file to view or analyze the data outside Study Designer.

ℹ️ Note: Data Dictionary files are useful for validation, reporting, and Insight table alignment.