Captivate Build User Guide v3.1

This document describes the features of Captivate Build 3.1. You access Captivate Build at https://portal.clincapture.com using a web browser. For a list of supported web browsers, consult the Supported Browsers section.

Captivate Build focuses on creating and designing studies.

** Please refer to the Captivate live User Guide to conduct and manage an existing study.   **

After the Getting Started section, the Building and Managing Studies section walks you step-by-step to build a study.

Information is provided at the end of the document to explain where to get help, sign up for free training and how to view FAQs for answers to commonly asked questions.

If you used Captivate to capture data for your study, you can reference it as follows:

“Data collection and management for this study was performed using Captivate 3.1, an EDC system developed by ClinCapture.”

This document is intended for study administrators who will use Captivate Build to design and build studies.

The following Internet browsers are supported to access Captivate Build:

• Microsoft Edge
• Mozilla Firefox 65 and above
• Google Chrome versions 30 and above
• Safari versions 6 and above

Captivate Build provides a comprehensive set of features to build and manage clinical studies, including:

• Creating studies
• Building the essential components of a study: forms, events, groups, rules, sites and users
• Promoting changes from test to production
• Sharing a study with others
• And more!

Captivate Build Features Overview by Module

Create an account in Captivate

You will need valid credentials to login.

Log in to Captivate

1. Point your browser to https://portal.clincapture.com. 
2. From the login screen, type your email and password.
3. Click Log in.

Log out of Captivate Build

1. Hover over your username in the header and select Logout.
   

Reset your Password

1. Login Captivate.
2. Click the > icon next to your email in the Header.
3. Click Change Password.
4. Enter your current password, then your new password twice.
5. Click Submit.

Recover your password

1. Click the Need Help to login? link on the login page.
2. Enter your email address and click Submit.
3. An email containing a link to create a new password will be sent to you.

Creative Build offers an intuitive and modern user interface. Many study build tasks can be accomplished using drag-and-drop, such as designing forms and rules, ordering events, etc.

A typical Captivate page includes the following components:

• Header to select a study to build, add a study, manage your account and upload your logo.
• Left Menu to select a study component to build, such as forms, rules, sites, users, etc.  You can also promote the changes to production, launch Captivate Live, access the form libraries and get help.  The Left Menu can be collapsed to increase the main page area.
• List pages include a title, a row counter, and icons to:
  add a component, show/hide filters and a More Menu to take additional actions such as display More Columns and Export the filtered list.
• Last Access Row orange markers highlight the last row that was accessed.

A sample list page is shown below.

Note:

• Some pages support mass action on multiple rows.
• To perform a mass actions , check the box on the desired rows  then click the Actions icon.  Only the actions valid for the selected rows will be enabled.
• You can select/deselect all the rows by checking the box under the page title.

After a period of inactivity, Captivate Build prompts you to keep the session active.  If you do not respond, your session will time-out and you will be logged out.

If you were designing a form when the session timed out, when you return, you are given the option to resume your previous session or start a new one.

If you decide to resume your session, you will be returned to the form design page from where the session timed out. Otherwise, you will be prompted to select a new study and your previous session will be terminated.
Note:

• You can resume a timed-out session on a different browser or even a different location.

This section walks you step-by-step to build and manage your studies, but first let’s examine the Captivate study operational model.

Captivate Study Operational Model

1. Once added, a New Study starts in the Not Deployed state
2. A study in the Not Deployed state can be either deleted or deployed
3. A Deleted study is no longer accessible
4. A study in the Deployed state can be:
   • Frozen
   • Archived
   • Locked
   • Decommissioned to be returned to the Not Deployed state
5. A study in the Frozen state can be:
   • Locked
   • Archived
   • Thawed to be returned to the Deployed state
6. A study in the Locked state can be:
   • Unlocked to be returned to the Deployed or Frozen state
   • Archived
7. A Study in the Archived state  can be:
   • Restored to be  returned to its original state: Deployed, Locked or Frozen
   • Decommissioned to be returned to the Not Deployed state

Notes:

• A study can be Shared and Cloned in any operational state.
• A study is Decommissioned only upon request to Support.
• When a study is Decommissioned, its forms are returned to the draft state.

To manage studies:

1. From the Left menu, click Study, or select another study in the Captivate Build header.
2. A similar page is displayed.
   
3. Select an action to be performed. You can either Edit your Study to change the study metadata, such as study name, protocol ID, configuration options, etc.
4. Or from the More Menu.
   

The following actions can be performed on Study, depending on its state.

This is the process to follow to create a study in Captivate Build. Just follow the instructions in each point to start building a study in your @Test environment until you promote it to your Production environment.

Build Steps for creating a Study:

1. Add Study
2. Add Forms
3. Deploy Study
4. Publish Forms
5. Add Events
6. Add Groups
7. Add Rules
8. Add Sites
9. Add Users
10. Going “Live”

To add a study:

1. Click the + icon in the header.

2. Complete the Study Properties. Watermarks are provided to help you determine the types of data you should enter. All fields are required and are marked with a red asterisk.

3. To create a study with the default options, click Submit.
4. To customize the study options, click Continue.

5. Click Submit.

To edit an existing study:

1. Click Study in the left menu to display the Study Info page.
2. Click Edit.
3. The study properties display. See Section Add Study for details.  You can edit them as necessary.

Notes:

1. Once a study is deployed, the Protocol Type cannot be edited.
2. Plans cannot be downgraded.  If a downgrade is required, contact your Sales representative

To delete an existing study:

• 1. Click Study in the left menu to display the Study Info page
  2. From the More menu, select Delete.
     
  3. Click OK to confirm you want to permanently delete your study and associated forms.
  4. A confirmation message displays when your study has been successfully deleted.

Notes:

• Deployed Study cannot be deleted. The Study must not be deployed for you to have the option to delete it.
• Study deletion, including associated forms, cannot be recovered.

Build Steps:

1. Add Study
2. Add Forms
3. Deploy Study
4. Publish Forms
5. Add Events
6. Add Groups
7. Add Rules
8. Add Sites
9. Add Users
10. Going “Live”

Before you can deploy your first study, you must establish a contract with a ClinCapture sales representative. If you are deploying a study on behalf of a sponsor, you must be authorized to do so.

To deploy your study:

1. Click Study in the left menu to display the Study Info page
2. From the More menu, select Deploy or Authorize (if you are not yet authorized to deploy a study).
   
3. Fill the required information.
   

• Chose your payment option: Credit Card or Contract.
• Select the Region to host your study
• Specify a unique Resource ID, an 8 characters word which by default is made of the first characters of the Sponsor name and a sequence number if needed. To create the URL for your study, Captivate Build will combine the Region selected will and the Resource ID as follow:
  • The Region URL is defined by the region you selected:
    • USA: https://us.clincapture.com/
    • Europe: https://eu.clincapture.com/
  • The resource ID defaults to the first eight characters of the Sponsor Name (excluding spaces and special characters) and a sequence number is added if needed to make it unique.  The resource ID can be edited, if necessary.

⇒ As a result, for example, if you selected Europe for the Region and newstudy for the Resource ID, your study URL would be: https://eu-clincapture.com/newstudy

4. Click Deploy or Authorize if you are not authorized to deploy a study.
5. The system will take about 3 to 5 minutes to provision your private Captivate server.

If you requested authorization to deploy a study:

1. The Sponsor Owner will receive an email requesting the study deployment and she will be required to deploy your study.
2. Once your study is deployed, you will be authorized to deploy additional studies for the same sponsor.

When a study is deployed, two identical study environments will be created in Captivate Build. The study name starting with @Test – allows you to build and test your study while the other will be used for production.  For example, assuming your study name is NEW STUDY, you will see two studies in Captivate:

• @Test – NEW STUDY: Used to build and test your study
• NEW STUDY: Used for production

You will be granted administrative access to both studies.

To clone a study:

1. Click Study in the Left menu to display the Study Info page
2. From the More menu, select Clone.
   
3. The study properties display. See section Add Study for details. You can edit them as necessary.
4. Click Clone.
   The study and associated forms will be cloned

Note:

• You can only clone a Study from and in the same private cloud.

Clone the Events, Groups and Rules

We started by cloning the study, but if you want to copy the events, groups and rules as well, you can promote the changes from your original study, to your clone, as follow:

1. In the study you just cloned click Promote in the Left menu to display the Promote Changes page
2. The dropdown menu “Secondary study” displays the study in production as well as the new clone of your study. For example, we cloned the study named: Prospine-3 and called the clone: Test Study Prospine.
   
3. Select the clone, Test Study Prospine
4. Click Generate Report
5. Click Promote all Changes

A study can be frozen, to prevent anyone to enter new data while still allowing the users to close discrepancies/queries. If you want to prevent your study from receiving any change at all, see Lock/Unlock Study.

Freeze a deployed study

1. Click Study in the Left menu to display the Study Info page
2. From the More menu, select Freeze.
   
3. Click OK to confirm you want to freeze the study.

Thaw a frozen study

1. Click Study in the Left menu to display the Study Info page
2. From the More menu, select Thaw.
3. Click OK to confirm you want to thaw the study.
4. Click OK to confirm you want to freeze the study.

Note:

• Studies must be deployed before they can be frozen/thawed.

A deployed study or a frozen study can be locked to prevent any change in the study. If you want te be able to still allow your users to close discrepancies/queries but prevent creating new data in the study, see Freeze/Thaw Study.

Lock a deployed or frozen study

1. Click Study in the Left menu to display the Study Info page
2. From the More menu, select Lock.
   
3. Click OK to confirm you want to freeze the study.

Unlock a locked study

1. Click Study in the Left menu to display the Study Info page
2. From the More menu, select Unlock.
3. Click OK to confirm you want to unlock the study.

Note:

• Study must be deployed or frozen before they can be locked or unlocked.
• Study returns to its previous state when it is unlocked.

To share an existing study with someone, you need to add a user and grant him the role “Study Administrator” and specific build permissions (see add user).

Archiving a study does not destroy data or the forms associated with it.  Once a study is archived, it can be restored to its deployed state, until it is decommissioned.

When you archive a study, an email is sent to Sales who will contact you to discuss archiving options.  All archiving options include receiving a compressed copy of your database . If necessary, your database copy should enable you to restore your study data. SAS datasets can also be provided upon request.

• Option 1 – Near-line forever: The study database will be kept near-line, allowing us to restore your study within 24-hours. This option includes a fee for archival and monthly storage. There is no limit to the retention period. There is no additional fee to restore the study.
• Option 2 – Archival: Your study database will be put offline and the system decommissioned. This option includes a fee for the archival process and an optional monthly fee for storage, should you require ClinCapture to store a copy of your database. Default retention period is 7 years, but additional retention time can be negotiated. Should you need to fully restore your study, a fee will be applied to restore your database.
• Option 3 – Backup for 8 weeks: If you do not require long term archival, your study data will be deleted and the system decommissioned. ClinCapture will keep a backup for 8 weeks, but not beyond. There is no archiving fee for this option. However, a fee will be applied to restore your study from our backup (within 8 weeks of the archive request) or from your electronic copy.

Archive a deployed study

1. Click Study in the Left menu to display the Study Info page
   
2. From the More menu, select Archive.
3. Click Archive Study to confirm you want to archive the study.
4. The study state is now Deployed and Archived.

Note:

• A study state must be deployed, Locked or Frozen before it can be archived.

Restore an archived study

1. Click Study in the Left menu to display the Study Info page
2. From the More menu, select Restore.
3. Click OK to confirm you want to restore the study.
4. The previous study state will be restored.

Study usage can be monitored in the Study Info Page. On this page you will find the number of sites, of form pages collected, the number of user roles assigned to the study and the total storage used.

The Sites metric includes the number of sites in your study.

The CRF Pages metric includes the number of form pages where data entry was initiated or completed, including following states: “Initial Data Entry Started”, “Double Data Entry Started”, “Data Entry Completed”, “SDV-ed”, “Signed”, “Locked” and “Removed” (but not deleted). A form page is defined as a form section or Tab. Thus, multiple form pages may be contained within a single form.

The User Roles metric includes all user roles defined in Captivate that are assigned to the study. Please note that if a person has many roles in different studies, the different roles are counted in this metric. However, if a user account has access to multiple sites within a study, it will count as one role.

The Storage metric includes data entered in the forms, form attachments and data imported or exported (and not deleted from the application). Please note that the storage related to the study configuration is not included.

Notes:

• Size thresholds depend upon your study plan.
• Usage metrics are updated once a day.
• When one of the metrics exceeds the size threshold (for example 11 sites in the Captivate Light plan), you will receive an email about this event and may be contacted by a Sales representative to discuss your needs.
• Metrics monitoring has evolved over time:
  • Studies created after 01-Sep-2017 – Only site metrics are applicable. Captivate Light has up to 10 sites and Captivate Standard up to 25 sites.  The Captivate Global plan has unlimited sites.
  • Studies created after 01-Apr-2017 , before 01-Sep-2017 – Only site metrics are applicable to the ClinCapture plans (up to 10 sites and up to 20 sites).  The Captivate plan has unlimited sites.
  • Studies created after 01-Oct-2016, before 1-Apr-2017 – Usage metrics are calculated your production studies only.
  • Studies created before 01-Oct-2016 – Usage metrics aggregate the total usage for your development and production studies.

System settings are available for:

• System
• Extracts
• Import
• Email
• Security
• Facility
• Reporting
• Randomization
• Medical Coding
• Job Server
• ePRO

Notes:

• Unless otherwise specified, the system settings are globally applied to a Captivate server and affect all studies hosted on the server.  Contact Support if you are unsure about what study maybe affected.
• Some settings, such as the database name and the URL,  affect the hosting environment and may not be editable.

Configure system settings

1. Click Study in the Left menu to display the Study Info page
2. From the More menu, select System Settings.
3. Edit the following system settings as required.

To manage forms:

1. From the Left menu, click Forms.
2. A similar page is displayed.
   
3. Click the Actions icon to select the action to be performed.
   

The following actions can be performed on Forms, depending on their state:

The More Menu includes:

• More Columns displays: Form OID, Version OID, SAS Naming, Require Labels, Build Notes, Description, and Comments.
• Import Form uploads a CRF compatible with Captivate (or OpenClinica) format in Excel.  Various CRF templates are available upon request to help you design your CRF in Excel, including Randomization and Medical Coding forms.  The Instruction tab in these templates provides direction to create your CRF in Excel.
• Export exports the filtered forms list.

Notes:

• Click the checkbox under the Forms title to select all or none of the forms displayed.
• You can filter the forms by CRF Name, Version, Status, Created date, Updated date, or Author. Simply start typing in one of the filter boxes. The list will filter to include those matching the entered characters. To re-display the whole list, remove the characters in the filter boxes.
• Click the column headers to sort the list in ascending or descending order.
• If multiple form versions exist, click the triangle icon in the version field to show/hide the version details.
• Click several checkboxes to apply a mass action: Publish, Clone, Unpublish or Delete.  Only actions that are valid for the selected forms are available.  For example, if all the forms selected are already published, then only the Unpublish and Clone actions will be available.

Build Steps:

1. Add Study
2. Add Forms
3. Deploy Study
4. Publish Forms
5. Add Events
6. Add Groups
7. Add Rules
8. Add Sites
9. Add Users
10. Going “Live”

Add a form

1. Click Forms in the left menu
2. Click the + icon in the Forms page.
3. Complete the form configuration. All fields are editable and required fields are marked with a red asterisk.

4. Click Continue to configure the form options.
   
5. Configure the form options These options control the behavior and display of the following parameters in the configuration panel.

   The items in your form can be configured with pre-set options such as auto-numbering. You can set a Yes or No default value to control the field behavior. The default behavior can be changed while designing the form if you check the box Allow override.

   For example, if most items in the form must be auto-numbered, while a few should be un-numbered, you should set Auto-number fields to Yes and check the box Allow override.

6. Click Design.
7. The form designer opens. See Design Form.
8. When you are finished designing your form, click Save & Exit.

Repeat this process until all the forms required in your study protocol have been created.

The form designer offers a simple yet powerful GUI to create all forms required in a clinical trial. It’s unique What-You-See-Is-What-You-Get (WYSIWYG) GUI allows you to visualize exactly how a form will look in Captivate Live, while designing it.

To design an existing form:

1. Click Forms in the Left Menu.
2. Locate the relevant form in the list, if necessary using the filtering and sorting features.
3. Click the Actions icon, then from the dropdown, click Design.

There are many ways you can organize and design your form’s layout simply by using drag and drop features. Refer to the images and guide below, using the numbers as a cross-reference.

Ref #	GUI Action	Result
1	Click tab	Toggles view between Form Studio and Form Library
2	Click or drag tool	Adds an item at the end of the form (different kinds of items are available, see form items)
3	Click form tab	Opens the page configuration panel
	Drag form tab	Relocates the page in a different order
	Click the + icon	Creates a new page
4	Click the <…> icon	Opens a new browser window/tab with the form specifications. The specifications can be printed or exported to Excel for review and submission.
5	CTL-C and CTL-V	Copies and pastes an item.  This icon indicates the copy buffer is ready to be pasted.
6	Drag from Left Text	Cursor is:Drags and drops the item icon into a table or grid.
	Drag from the shaded area’s right edge	Cursor is:  Resizes the width of the Left Text.
	Click anywhere	Opens a panel to configure the area highlighted in yellow.
7	Drag from Right Text	Cursor is: Relocates the item on the form.
	Drag from the shaded area’s right edge	Cursor is: Resizes the width of the Right Text.
	Click anywhere	Opens a panel to configure the area highlighted in yellow.
8		Indicates that an item has skip logic or is referenced by skip logic.
9	Click and drag the column header on a table or grid	Cursor is:Reorders table or grid columns.
10	Drag column dividers	Cursor is:  Resizes grid and table column widths.  Note that the minimum width of a column is determined by the Right Text width.
11	Drag the right edge of a grid or a table	Cursor is:Resizes the grid or the table’s width.
12	Drag from the blue control bar	Cursor is:Drags a question out of a grid or a table, onto the form’s workspace.
13	Click the + icon	Adds a column to the right inside a table or grid.
	Click the x icon	Deletes a column from a table or grid.
14	Red border	Highlights inconsistent items. Inconsistent items must be fixed before the form can be saved.  For example when you copy and paste an item, it will be inconsistent because it has a duplicate item name.  You can also create inconsistent items using the library, for example copying an item with a duplicate option label, or referencing an option label that does not exist, etc.

A form can be organized in several pages to group information to be collected. For example, a Screening form may include Inclusion, Exclusion and Demographics pages. This allows the collection of logically related data within the same form. When you first open the form designer, one page is provided for you by default, but you can add additional pages, as necessary.

Configure a page

1. Position your mouse on the form tab. The entire page will be highlighted in yellow.
   
2. Click the page tab.
3. Complete the page configuration form
   

   Configuration	Build Notes
   Page Name Title Subtitle Instructions Javascript	Build Note

4. Click the + sign to add more pages if desired.
   

Notes:

1. All items must be deleted first before you can delete a page.
2. A page must contain at least one item before you can save it.
3. Title, Subtitle and Instructions accept a subset of HTML elements, if additional visual effects are necessary.

You can enter any instructions for the data entry person to fill out this section of the CRF. You can bold, italicize, underline, and/or change the text’s color.

This field appears as a CRF Page property only if study plan is Captivate.  It allows programmers to extend the CRF functionality by including JavaScripts.  For example, the subject’s age can be automatically calculated from the date of birth.  Other computations such as complex scores and sophisticated visual effects can also programmed; for example highlighting the area clicked on an image.  

JavaScript programming is beyond the scope of user guide.  Please contact support for available Javascript samples.

Enter a unique page name. The page name is displayed in the tab at the top of the CRF. The CRF page name can be clicked to access different page. If no page name is entered, Form Studio uses Page name by default and numbers pages sequentially. For example: Page name 1, Page name 2, etc.

Type the text that should appear as the page title on top of the CRF in a grey bar. By default, Form Studio uses Page Name if no title is provided. You can bold, italicize, underline, add superscript or subscript, and/or change the text’s color. Line breaks are permitted.

You can enter a subtitle for a CRF section. The subtitle is displayed under the CRF title in a grey bar. You can use a subset of HTML elements in this field. You can bold, italicize, underline, add superscript or subscript, and/or change the text’s color using the Rich Text Editor. Line breaks are permitted.

A form item is typically composed of a Left Text, Input field and Right Text.  However, some exceptions exist for certain items such as divider, grid, table, etc.

Add an item to your form

Simply click or drag and drop the item type you want to add to the form’s workspace. You can add any combination of the following item types.

Field Type	Description
	A text item. The user will type text data directly into a field.
	A number item. The user will type numerical data directly into a field. Integer and decimal numbers can be specified.
	A calculation item. Will display the result of a calculation, rather than requiring data entry.
	A list item. Users will select options from a drop-down list.
	A radio button item. Users will select an option by clicking a button.
	A checkbox item. Users will select options by clicking checkboxes.
	A date item.
	A time item.
	A file item. You can attach a file with this item.
	A table item. Users will fill out data in table format. Rows can optionally be labeled.
	A grid item. You can organize questions in a grid format, which allows more than one question to display in the same row.
	A visual divider. You can add a divider to visually separate sections of questions on the form. A divider must always be followed by one or more questions. Dividers cannot be followed by a table, or any items containing a Header.
	A medical coding item. Note: This option is available if you selected Medical Coding as an add-on for the study.
	A randomization item. Note: This option is available if you selected Randomization as an add-on for the study.

2. After you add an item onto the form’s workspace, the next step is to define its properties. To do so, hover your mouse over the item.  When it is highlighted, click your mouse to open the configuration panel.
3. The actual pop-up you see depends upon the item type you added and the browser you are using.  Refer to the images and guide below, using the numbers as a cross-reference.
   

4. Complete the item configuration. Detailed information about the properties for each item type is provided below.
5. You can relocate any item on the form by clicking the Right Text and dragging it up or down the form’s workspace, to its new position.
6. If necessary, input fields can be dragged to the right, closer to the Left Text, or the form margin if there is no Left Text. See Form Designer for details
7. You can also relocate a column in Table and Grid items by clicking on the header and dragging it to its new location. Make sure the area is highlighted in yellow before releasing the mouse, as it may take a few seconds on large tables.
8. You can copy an item by hovering your mouse over the item to highlight it, then using standard CTRL-C/CTRL-V keyboard shortcuts to copy and paste it. Pasting the item places it at the bottom of the form. You can then relocate the item as necessary.
9. After you have added all necessary items to the form, click Save & Exit.
10. You are returned to the Forms list from where you can publish the form once it is final.

If you added a Calculation item, click on the right of the input field to define its properties in the configuration panel. Required properties are marked with a red asterisk. The following properties can be configured for Calculation. Click any property below to see its description:

(*) Item-specific configuration option.

If you added a Checkbox item, click on the right of the input field to define its properties in the configuration panel. Required properties are marked with a red asterisk.  The following properties can be configured for Checkbox.  Click any property below to see its description:

(*) Item-specific configuration option.

If you added a Date item, click on the right of the input field to define its properties in the configuration panel. Required properties are marked with a red asterisk.  The following properties can be configured for Date.  Click any property below to see its description:

(*) Item-specific configuration option.

Dividers allow you to create sections within a page by assigning a header to a group of items. Dividers are not allowed to be followed by a table or any item containing a Header. The following properties can be configured for Divider.  Click any property below to see its description.

• Name (*)

(*) Item-specific configuration option.

If you added a File item, click on the right of the input field to define its properties in the configuration panel. Required properties are marked with a red asterisk.  The following properties can be configured for File.  Click any property below to see its description:

Grids provide a way for you to organize the items into multiple columns, this displays more than one question on the same line.

To add a grid:

1. Click or drag and drop the Grid item type to add it to the form’s workspace.
2. A default grid is added at the bottom of the form’s workspace, which is comprised of one row and two columns.
3. Click just outside the grid outline to specify the number of rows and columns you want to add to your grid. Note that a grid cannot contain less than two columns. Extraneous empty rows and columns will be removed when you save the form.
4. Drag and drop any item into one of the spaces on the grid, except: grid, table, randomization and dividers items.
5. You can resize the column widths by dragging the column dividers inside the column headers to the left or right.  See Design Form for details.
6. Complete the properties configuration for the item type you added.
7. The following properties can be configured for Grid.  Click any property below to see its description:
   • Columns (*)
   • Rows (*)

   (*) Item-specific configuration option.

Notes:

1. Continue to drag and drop items and configure them until your grid is complete.
2. You can relocate columns inside the grid by clicking and dragging the column blue control bar to its new location while keeping the mouse pressed down.  See Design Form for details.
3. If needed, click the + icon to add another column to your grid. Or, click the x icon to delete a column from your grid.

If you added a List item, click on the right of the input field to define its properties in the configuration panel. Required properties are marked with a red asterisk.  The following properties can be configured for List.  Click any property below to see its description:

(*) Item-specific configuration option.

1) Only available for CRF with Randomization (see Edit Form) and when a Randomization item has been added to the form.

Before you can assign medical codes to your verbatim items, you must contact ClinCapture to configure your access to the medical coding appliance. ClinCapture will also verify that you have a valid license for the ontology you need to access.

If you added a Medical Coding item, click on the right of the input field to define its properties in the configuration panel. Required properties are marked with a red asterisk.  The following properties can be configured for Medical Coding.  Click any property below to see its description:

(*) Item-specific configuration option.

Note: The Medical Coding item is available only if you selected Medical Coding as an add-on for the study.

If you added a Number item, click on the right of the input field to define its properties in the configuration panel. Required properties are marked with a red asterisk.  The following properties can be configured for Number.

Click any property below to see its description:

(*) Item-specific configuration option.

If you added a Radio Button item, click on the right of the input field to define its properties in the configuration panel. Required properties are marked with a red asterisk.  The following properties can be configured for Radio Button.
Click any property below to see its description:

(*) Item-specific configuration option.

Before you can randomize subjects, you must contact ClinCapture to configure the randomization scheme for your study. The following information is required:

• Randomization method: Simple or Block.
• Block size (if method is Block)
• Stratification variables (if any)
• Masking: Open, Blinded, Double-blinded
• Sites allowed to randomize.

Click on the right of the input field to define the Randomization item properties in the configuration panel. Required properties are marked with a red asterisk.  The following properties can be configured for Randomization.
Click any property below to see its description:

(*) Item-specific configuration option.

Notes:

1. The Randomize Subject button and two fields are added automatically:  Randomization result and Randomization Date.  You cannot change or remove them.
2. In addition, if the Kit ID option was selected, this field will also be added to the form’s workspace.
3.  The Randomization item is available only when Randomization is selected as an add-on for the study.

To add a table:

1. Click or drag and drop the Table item type to add it to the form’s workspace.
2. The first table column is automatically added for you.
3. Drag and drop any of the items in the column. Make sure the drop location is highlighted in yellow before releasing the mouse. A new column will be inserted.  Note that the following items cannot be dropped into a column: grid, table, dividers and randomization.
4. Click the column header to configure the dropped item.
5. Click and drag the column header to move a column to a different location on the table. Make sure the drop location is highlighted in yellow before releasing the mouse.
6. You can resize the column widths by dragging the column dividers inside the column headers to the left or right.
7. Click the + sign to add additional columns, if needed, and add items as previously described.
8. Hover on the edge of the Table item to highlight the entire table, then click to define the Table item properties in the configuration panel. Required properties are marked with a red asterisk.  The following properties can be configured for Table.  Click any property below to see its description:

(*) Item-specific configuration option.

Note:

• When you include an item inside a table, the item does not have anymore the option to have a header or a subheader.

If you added a Text item, click on the right of the input field to define its properties in the configuration panel. Required properties are marked with a red asterisk.  The following properties can be configured for Text.
Click any property below to see its description:

(*) Item-specific configuration option.

If you added a Time item, click on the right of the input field to define its properties in the configuration panel. Required properties are marked with a red asterisk.  The following properties can be configured for Time.
Click any property below to see its description:

(*) Item-specific configuration option.

Refer to Form Items for a list of configurable properties supported by each item.

Select Yes to automatically number items as they are added to or re-positioned in the form. Parent questions are numbered with a sequential integer such as: 1. 2. 3. etc.  Child questions and table columns are sequentially numbered with a letter, for example 1.a 1.b 1.c etc.

Select No to disable automatic question numbering. If necessary, you can type your own numbering scheme in the item’s Left Text.

Allows users such as data managers to associate build notes to any item on a form.  Such note may, for example, include an edit check specification for a field or provide a comment to the study builder.

Build notes are also used to store comments from users with Reviewer role.  The comments are authenticated and timestamped.  They cannot be deleted.  In addition, the build notes are included in the form specifications.  Here is sample interaction between a collaboraor and a reviewer.

Enter the calculation that should be run. The calculation will be an expression that takes the inputs of items of type Number. Note that once a CRF is published, the calculation cannot be changed. If a different calculation is needed, you will need to change the name of the CRF item.

The calculation syntax is:

• func:   ( argument operand argument )

-or-

• func: function( argument [, argument, … ] )

Where ‘argument’can be one or more of the following items:

• An item name inside the CRF
• A number
• A nested function.

‘Operand’ can be any mathematical operation: + – / *

‘function’ is one of the functions below:

Examples:

pow() uses two arguments: a number and the power. For example pow( 2, 3 ) is 8. We can use 0.5 for the square-root, thus pow(25, 0.5) is 5.

We can calculate the absolute difference between Item1 and Item2, using: func: pow( pow( Item1 – Item2 , 2 ), 1/2). This functions first takes the power of 2 of the difference between Item1 and Item2 and then takes the square-root, resulting in the absolute difference.  decode() uses 3 arguments: a variable to evaluate, one or more key-value pairs, a default.

Let’s say you want to enter a temperature in either Fahrenheit or Celsius but store the temperature in Celsius, regardless of the unit chosen. You will need the following items in your CRF:

• Temp, a Number field to enter the temperature.
• Unit, a List or Radio Button field with 2 temperature unit options: F to indicate Fahrenheit and C for Celsius.
• Result, a Calculation field to store the temperature in Celsius, regardless of the temperature unit selected.

In our example, arg is Unit. If the Unit argument equals C, then we will store the value of item Temp as-is in the Result field. We will use the Fahrenheit conversion as the default, thus we will subtract 32 and then multiply it by 5/9. Therefore, our decode function is: func: decode( Unit, C, Temp,((Temp-32)*5/9)).

Note that the calculation is performed when the CRF is saved. However, instant calculations can be performed with the onchange() function with arguments of an item name (the trigger item) and value.

Number of columns configured in the grid when it is initially displayed. Columns number can be added by clicking on the ‘+’ icon or deleted by clicking on the trash icon in the column header. Unused right-most columns are truncated when the CRF is saved. Unused columns are not allowed in the middle of the grid.

If a default value should display for this question on the CRF, select it from the drop-down list. The default value will be saved to the database if the user does not enter anything prior to saving the CRF.

If a default value should display for this question on the CRF, enter it here. The default value will be saved to the database if the user does not enter anything prior to saving the CRF.

Performs a calculation using variables entered in a table format.

• Select Yes to perform a tabular calculation.
• Select No to perform a non-tabular calculation.

Description or definition of the CRF item that is used for reporting in SAS or other BI tools. This information is not shown on the CRF. If SAS naming restrictions are enforced, the Reporting Labels can be up to 40 alphanumeric characters, including spaces. Reporting Labels must be unique within a CRF.

Select a medical coding dictionary from the drop-down list. Once a CRF is published, the Dictionary cannot be changed.

Allows to control the size of the input field.  This configuration option is only displayed if a validation is specified for a CRF item.

To run an edit check at the time of data entry, enter a validation expression. The validation will run when the user saves the CRF. If an expression is specified, you will be required to enter a failed validation message to be displayed when the data does not pass validation. The validation must be between 1 and 2000 characters should be of the format:Expression-Type: Expression

The following two expression types are supported:

• regexp: /regular expression/ Regular expression is a Java-style expression. For more information, see: https://regex101.com/#javascript

      This example requires a three-letter string (all uppercase): regexp: /[A-Z]{3}/

• func: operator(argument)

      Argument can be either a hard coded number or an item name inside the CRF. Operators currently supported include:

This example requires a number between 1 and 10: func: range(1, 10)

This example requires a number equal to CRF item name AGE: func: eq(AGE)

Notes:

1. Use Rules Studio for more complex rules or cross-forms edit checks.
2. This field is not used for a Date, File, or Medical Coding type items.
3. For the Time item type, the proper field validation is already provided to ensure a properly 24-hour formatted time is entered. You cannot change this expression.

Can be used as a replacement for left and right item text or as a replacement for instructions. You can use a subset of HTML elements in this field. You can bold, italicize, underline, add superscript or subscript, and/or change the text’s color using the Rich Text Editor. Line breaks are permitted.

Note: When headers are used in items inside a Grid, only the left most item header is displayed on the CRF.

Uniquely identifies the variable name for the CRF item. CRF Item Name is used to manipulate the data item programmatically. To ensure compatibility with SAS, the item name length is 8 and must start with an alpha character. When the SAS naming restriction is not enforced, the item name length is 40. It must be composed of alphanumeric characters and underscores and may not contain any spaces.

Note:

If a previously-published CRF item is renamed, the effect to rename a CRF item is that the old item is deleted and a new item is created. If data was entered on the original version, and then on the new version, the same information is collected in two fields. When the data is extracted, the data collected in the two fields will need to be manually merged in SAS.  Also when re-assigning a CRF old version to a new version, the data collected under the previous item name will be lost, as the item name no longer exists in the new version.

Select Yes if table rows should be labeled. You can edit the row labels on the table by clicking on them.Click Label 1 to specify a descriptive name for the first row, as well as the column header. Then continue to click each Row Label to specify a descriptive name for the each of the rows.

Select whether to display the options horizontally or vertically.

Type the text that should appear to the left of the item on the CRF, using up to 4000 characters. You can use a subset of HTML elements in this field. You can bold, italicize, underline, add superscript or subscript, and/or change the text’s color using the Rich Text Editor. Line breaks are permitted.

Here below an example of a Left text for a Date field:

Which in the Date Field Configurator is:

Note: Left Text is not available if the CRF item is placed inside a table.

This property restricts users from adding rows beyond the specified number. However, this restriction works only if data are entered interactively through Captivate’s GUI. If data are imported from a file or sent through web services, all data will be allowed to import, even if the rows of data exceed the specified number.

Min rows specify how many blank rows should exist for the table upon initiation of data entry, or when printing a blank CRF from Captivate. A user can add more rows to the table, up to the Max rows and remove some of unused rows. In a labeled table, you can reduce the number of rows by changing this value. The reduction will cause rows to be deleted from the bottom of the table.

Specify the minimum and maximum number of characters the question answer is allowed to be. Max text size must be blank, equal to or greater than Min text size.

Select Yes to allow users to select multiple options from the list by pressing the Control or Shift keys.

Type the text that should appear inside the section divider. You can bold, italicize, underline, add superscript or subscript, and/or change the text’s color. Line breaks are permitted.

Specify whether the number should be an Integer or a Decimal. Real and float data types are considered decimals. Note that once a CRF is published, you cannot change the type of number you originally specified.

The option label gives you the possibility to quickly reuse the options set you defined in another List item.

The label must be unique, composed of alphanumeric characters and may not contain spaces. If you have previously defined an option label, you can select one from the drop-down list “Select” to reuse it in this question. The saved option Names and Values will automatically populate the field (see Options Name/Value).

Note:

• A single select list cannot reference an option label from a multi-select list.

Enter the names and values for the options to display in the list. Any character, including a comma, can be used as an option name or value. One or more blanks are allowed for Option Name.

Note:

• Once a CRF is published, you can add new option names and values but you cannot change or delete published names and values.

Select Yes to allow users to enter a partial date if the full date is unknown. Note that once a CRF is published, you cannot change the type of date you originally specified.

For example: FEB-1978

Select Yes to flag the CRF item as Protected Health Information.  When this study feature is enabled, data marked PHI , for example a subject’s date of birth, is obfuscated when it is accessed by Study-level users.  PHI data is masked to study-level users when they:

• View the data within the CRF.
• Source data verify a CRF.  If PHI data must be SDV-ed, it must be done by a Site Monitor.
• Export the data.  Unmasked PHI data can only be exported by a CRC,  an Investigator or a Site Monitor user.
• Query the data.  All PHI data is masked in the query and in the Notes and Discrepancies page.
• Access the audit log.  Before and after values are masked.

Notes:

1. Selecting the eSource add-on will automatically enable PHI data protection for a study.
2. Once enabled, PHI data protection cannot be disabled by the Owner.  To do so, please contact ClinCapture Support.

Select one of the following:

• Treatment group

Automatically assigns the randomized subject to a treatment group.   Treatment Groups those names correspond to the randomization result must be defined; for example “Radio Therapy”.   See Add Group for details.

• Subject ID

Automatically changes the Subject ID to the randomization result.

• Neither

The randomization result is simply stored in the CRF.

Select one of the following:

• Randomization ID

Returns a randomization ID.

• Randomization ID + Kit ID

Returns a randomization ID and a kit ID.

Select Yes if the CRF item should be read-only in Captivate.

Select Yes if the user is required to answer this question.

Note:

• If a field is required but is hidden by skip logic, data is not required to entered unless the field is shown.

Select Yes to allow the user to adjust the size of the text box. This is very useful if a large amount of text must be entered.

Type the text that should appear to the right of the input field on the CRF, using up to 2000 characters. Used to ask a question, specify a unit, or provide supporting instructions or other comments. You can use a subset of HTML elements in this field. You can bold, italicize, underline, add superscript or subscript, and/or change the text’s color using the Rich Text Editor. Line breaks are permitted.

Here below an example of a Right text for a Date field:

Which in the Date Field Configurator is:

Note: Right Text is stripped if the CRF item is placed inside a table.

Number of rows configured in the grid when it is initially displayed. Rows can be added or deleted. Deleted rows are removed from the bottom. Unused bottom rows are truncated when the CRF is saved. Unused rows are not allowed in the middle of the grid.

You can use skip logic to dynamically show hidden items on a CRF.

• Select Show to show a question when the CRF is opened.
• Select Hide if the question should initially be hidden when the CRF is opened, then displayed based on a trigger condition you specify. If Hide is selected, additional configuration is needed to specify a trigger condition, including:
• The CRF item name is the name of a CRF item containing options. Only list, radio buttons and checkbox item names will be available in the dropdown menu.
• The Option name is the name of the option in the item specified above to trigger the display state change. It must be selected from the dropdown menu.
• The Error message is the error to be shown if the user triggers the display condition, enters information, then removes the triggering condition. For example, the user selects ‘Female’ for the subject’s gender, answers the pregnancy question then goes back and changes the subject’s gender to ‘Male’. The appropriate error message, in this case, would be, for example: “Do not answer pregnancy question if the subject is male.”

Notes:

1. If you enter data in a question that contains skip logic, the skip logic will be executed.
   • If the data condition is met, the display status of the skip item will be changed.
   • If the data condition is not met, the skip item is put in its initial display state.
2. Questions that use skip logic are marked with an information icon. Hover your mouse over the icon to see this message.
   

3. If a field is required but is hidden by skip logic, it does not require being completed. A field requires to be filled only if it is shown.

Set to Yes if this specific item must be source data verified.  Otherwise, set to No.

If you selected Randomization as an add-on for your study, you can designate this CRF item as a stratification variable. Note that the randomization scheme, including stratification variables, must be configured by ClinCapture before you can randomize subjects. See Randomization Item for details.

Note:
Items marked as a strata variable cannot be modified or deleted once they are published.

• Select Yes to mark this CRF item as a stratification variable. Form Studio will also assign a special CRF item name to this field that cannot be edited.
• Select No and this CRF item is not used as a stratification variable.

Once a CRF is published, items configured as a stratification variable cannot be relocated or reconfigured.

If you are using a Header for this item, you can specify a subheader. The subheader text displays underneath the Header, is separated by a line and has a grey background. You can use a subset of HTML elements in this field. You can bold, italicize, underline, add superscript or subscript, and/or change the text’s color using the Rich Text Editor. Line breaks are permitted.

The subheader must be 240 characters or less.

Uniquely identifies the variable name for the Table item. Table name is used to manipulate the data item programmatically.

To ensure compatibility with SAS 9.2 naming, the Table item name length can be up to 8 characters and it must start with an alpha character or an underscore.  Spaces and SAS reserved keywords are not allowed.

When the SAS naming restriction is not enforced, the item name length is 40.   The name must be composed of alphanumeric characters and underscores and may not contain any spaces.

Note: Previously-published Table item cannot be renamed.

Specify a validation expression to run an edit check on this CRF item.

Select the validation type for a number field.

• None
  No validation is used.

• Min/Max range
  Specify the minimum and maximum values for the number, as well as a default number. If the number is a decimal, the values specified in these properties must also be a decimal and meet the decimal size requirement.
  Validation message: You can personalize the validation message. By default it will take the minimum value you entered as well as the maximum value and display something like
  Number must be within the range of: 0 to 10
  for example, if you set your min at 0 and max at 10.

• Enumerated values
  Specify the valid enumerated values. The format should be a number followed by a vertical bar and a number (NUMBER|NUMBER). For example, if valid responses are 0, 1, and 9, you should enter 0|1|9.

The Library gives you access to existing forms and allows you to reuse these existing forms or parts of them into your current form.

To add one or more items to your CRF from the Library:

1. Select the Library in the left panel
   
2. In the left panel, select where are the forms you which to copy from (Shared studies and/or Standard Forms)
3. Navigate in the right panel until you find the forms that interest you, and click the Action menu. For example here, we select the Adverse Events.
   
4. Click View
5. The Form Adverse Events appears in the right panel
6. From this view, you can select the existing items, or even the whole page
7. The left panel will update informing you of the number of selected items you have.
8. Once your selection is over, click on Copy
9. Then click on Form in the left panel to go back to the Form Designer
10. The copied items should be added to your CRF; see considerations for copying items with skip logic and response labels below.

Notes:

1. You can use the library to copy an entire page or section of a CRF. To copy a page, click the checkbox in the CRF tab. This will automatically select all the items. When you click the Form tab to return to your CRF, you have the option to copy the items to a new page in the CRF or the existing page.
2. To copy a section, click the checkbox in the CRF divider. All questions up to the next divider or end of the CRF will be selected.
3. You can reset, or un-copy, the CRF items prior to returning to the Form tab by clicking Reset.
4. Items are not renamed during the copy operation. You can copy the same items multiple times but you must assign them unique item names before saving your CRF.
5. The following must be considered when using the library to copy questions involved in skip logic. In the points below, the skip logic reference (the CRF item name used in the skip logic) is called the parent item. The items containing the Hide skip logic are called the children items.
   
   • If a child item is selected, the parent item involved in the skip logic will be automatically selected. If the parent item is inside a grid, the entire grid will be selected.
6. If after copying any items need to be fixed (for example, if there are duplicate item names or labels or a parent in skip logic is missing), they will be highlighted with a red border and must be fixed prior to saving the CRF.
   

To view, print or export the form specifications:

1. Click the Specifications link at the top of the form ()
2. A page opens in a new tab that displays the specifications for the form.
3. Click the Print or Export to Excel button at the bottom left of the page to print or send the form specifications to Excel.

Captivate Build provides three CRF libraries to facilitate reuse and speed up study builds:

• My Forms, a user library containing CRFs created or cloned by a user or CRFs from studies shared with a user.
• Company Standards, a corporate library of Studies and CRFs managed by the user with Standards Management features.  See Company Standards for details.
• Industry Standards, a global library of CRFs managed by ClinCapture. It includes CRFs that conform to the CDASH standard and others.

To access CRFs in My Forms library:

1. From the left menu, click LIBRARIES.
2. Select My Forms in the submenu.
3. The CRFs contained in the library are listed.
4. To display additional CRFs from shared studies, check the Include CRFs from shared studies box.
5. Use the drop-down lists to find CRFs from your library for a specific private cloud, Study Name, and click Search.
6. Click More to display the Therapeutic Area and Comments columns associated with a specific CRF version.
7. You can also use the provided filters to filter the CRFs by CRF Name, Private Cloud Name, Therapeutic Area*, Version, Comments*, Status, Created date, Updated date, or Author. Simply start typing in one of the filter boxes. The list will filter to include those matching the entered characters. To re-display the whole list, remove the characters in the filter boxes. Click the up/down arrows to sort the list in ascending or descending order.
   *These columns are visible only after having selected More as previously explained.
8. Click the CRF menu action and select View or Clone.  View opens the CRF is read-only mode.  To clone a CRF, see Clone Form for details.
   

Notes:

1. Mass action is possible by checking boxes, next to the action menu, to select multiple CRFs.
2. Standards Management feature gives access to all the forms developed in the organization when the Include CRFs from shared studies box is checked.

Captivate Build offers a very flexible mechanism to setup, manage and access a company-wide library containing standard studies and CRFs for certain therapeutic areas or study types.

You can allow a Study Administrator to have Standards Management rights when you create or edit the user account.

The following features become available to them:

1. Create a study and include it in the company standards library. When a study is included in the company standards library, all of its CRFs will be included in the Company Standards library.
2. View all the studies created within your organization, including those for different sponsors, if applicable.
3. Clone any CRF created in your organization from My Forms library into a standard study.
4. if a CRF becomes obsolete it can be hidden from the company standards library, or versioned if the standards change.

Notes:

• As Study Administrator, this user will have access to the Live interface.
• You can only add Standards Management accesses from the @Test environment, not from the Production.
• You can prevent the user to access the Production environment by not checking the option: “Add user to production study” when creating the user account
• If you want to give a user access to the forms and library standards without giving them the rights to make edits, see Form Reviewer/Viewer roles in User Permissions

First, the users with Standards Management rights must create a study and include it in the Company Standards library:

1. From the Header, Click the + to create a new Study
2. Fill the study details
3. If the study does not contain CRFs specific to a therapeutic area, select Not Specified in the Therapeutic Area dropdown list
   
4. Check the box Include study in Company Standards
   
5. Click Submit.

If a study already exists:

1. In the Header, navigate the STUDIES
2. Locate the study to be designated Company Standards
3. From the study, select Edit
4. Check the box Include study in Company Standards
5. Click Submit.

Next, the CRFs to be included in the standard study must be cloned from other studies or created by a Study Administrator.

Notes: 

1.  Many studies can be designated as Company Standards. For example, a Sponsor may have different standard studies for different therapeutic areas. A Clinical Research Organization may have different standards for different Sponsors, etc.
2. The user with Standards Management has read access to all CRFs created within his/her organization. In addition, they can review these CRFs and create build notes for the study builder, for example, to inquire about non-standard CRFs items.

Users with Standards Management rights can add, delete, hide or assign a new version to CRFs belonging to Company Standards studies.

Add a CRF

1. New CRFs can be created from scratch (see Add Form)
2. CRFs can be cloned from any other study created for a given organization, using My Forms library (see Clone Form).  They can then be optionally modified to adhere to a specific standard.

Delete a CRF

1. CRFs must unpublished if previously published.
2. Click Delete from the CRF menu option.
3. The CRF is deleted from the CRF list in Form Studio (See Delete Form)

Hide a CRF

1. Select Users from the Left menu
2. Click the Action menu on the user you want to hide a form to
3. For the forms you want to Mask, click Yes in the column Mask this CRF (see Hide Form)

Assign a new version to a CRF

1. Select Design from the CRF menu option.
2. Make the necessary changes to the CRF in Form Studio.
3. Click Save or Save&Exit
4. A new version of the CRF is automatically created as Draft (here the version 0.1)
   
5. Click on the Action menu
6. When you publish the CRF, you can assign a new Version number
   

Any user within an organization has access to the Company Standards library. See Form Libraries for details.

To access CRFs in My Forms library:

1. From the left menu, click LIBRARIES.
2. Select Industry Standards in the submenu.
3. The CRFs contained in the library are listed.
4. Click More to display the Therapeutic Area and Comments associated with a specific CRF version.
5. You can also use the provided filters to filter the CRFs by CRF Name, Therapeutic Area, Version, Comments, Status, Created date, Updated date, or Author. Simply start typing in one of the filter boxes. The list will filter to include those matching the entered characters. To re-display the whole list, remove the characters in the filter boxes. Click the up/down arrows to sort the list in ascending or descending order.
6. Click the CRF menu action and select View or Clone. View opens the CRF in read-only mode. To clone a CRF, see Clone Form for details.
   

Note:

1. Mass action is possible by checking boxes, next to the action menu, to select multiple CRFs.

To view a form:

1. Click Forms in the Left Menu.
2. Locate the relevant form in the list, if necessary using the filtering and sorting features.
3. Click the Actions icon, then select View.
   
4. The form opens in view mode. You can see the form but you cannot make any changes to it.
5. When you’re done viewing the form, click Back.

Clone a single form within a study

1. Click Forms in the Left Menu.
2. Locate the relevant form in the list, if necessary using the filtering and sorting features.
3. Click the Actions icon, then from the dropdown, click Clone.
4. A sequential number is appended to the CRF name to make it unique.
5. Optionally, edit the form name, version, brief description and comments.
6. The cloned form appears in the forms list.

Clone multiple CRFs within a study

1. Click Forms in the Left Menu.
2. Locate all the relevant forms in the list, if necessary using the filtering and sorting features.
3. Select the CRFs you want to clone
   
4. Click the Actions icon, then from the dropdown, click Clone.
   
5. A similar confirmation window is displayed.
   
6. Click Clone.
7. A sequential number is appended to the CRF names to make them unique.
8. The cloned forms appear in the forms list.

Clone forms from Libraries

1. Click Libraries from the left menu.
2. Select the desired library to clone from:
   
3. Once in the Library, locate the relevant form(s) to be cloned in the CRF table, if necessary using the filtering and sorting features.
4. From the Action dropdown, click Clone.
5. Select the destination study.  By default, your current study will be selected but you can select another one, as needed.
6. If a single form is cloned, you can edit the form name, version, brief description and comments, as needed.
7. Click Clone.

To edit an existing form:

1. Click Forms in the Left Menu.
2. Locate the relevant form in the list, if necessary using the filtering and sorting features.
3. Click the Actions icon, then from the context menu, click Edit.
4. Make any necessary changes to the CRF properties. Required fields are marked with a red asterisk.

6. Click Continue to complete the Field Options. These options control the parameters that display on the configuration panel.

   The items in your form can be configured with pre-set options such as auto-numbering. You can set a Yes or No default value to control the field behavior. The default behavior can be changed while designing the form in Form Studio if you check the box Allow override.

   For example, if most items in the form must be auto-numbered, while a few should be un-numbered, you should set Auto-number fields to Yes and check the box Allow override.

   Tips for configuring your defaults:

   • Hover over the left option text to learn more about it.
   • Set the option default value.
   • These options will not be configurable in Form Studio unless you Allow override.

   

7. Click Save.

Update a form

A form can be updated without repercussion on the forms that are in use. When a form is updated, Captivate Build creates automatically a new minor version of this form.

1. Click Forms in the Left Menu.
2. Locate the relevant form in the list, if necessary using the filtering and sorting features.
3. Click the Actions icon, then from the context menu, click Edit.
4. Make the necessary changes to the CRF in Form Studio.
5. Click Save or Save&Exit
6. A new version of the CRF is automatically created as Draft (here below the minor version 0.1)
   

Assign a New Version to the form

1. Click on the Action menu
2. Select Publish the CRF
3. The option to assign a new Version number to your form will be displayed
   

Show/hide New Versions in a Site

When creating a new version and published it, it is automatically added in the Event pop-up in Captivate live. You can choose to hide it from Captivate live and only show one version by editing the site.

1. Click on Sites in the Left menu
2. Edit the Site for which you want to show/hide new versions
3. in the section Update Site Event Definitions
4. Go to the CRF that has several versions and from which you want to show/hide versions
5. Select the Versions you want to show to the user
   

Show/Hide New Versions in an Event

1. Click on Events in the Left menu
2. Click on the Action menu of the Event where the CRF is located
3. Select Edit
4. In the CRFs part, find the CRF you want to modify
5. Tick the checkbox to “Show New CRF Versions to Sites”
   
6. Click Continue
7. Submit to save the changes

From this moment on, every new CRF Versions that you will create will be available to choose from in the Captivate Live interface.

Notes:

• To revert this and hide the new CRF, remove the tick from this checkbox
• Make sure to select the right CRF Version in the Default Version Drop Down list

Build Steps:

1. Add Study
2. Add Forms
3. Deploy Study
4. Publish Forms
5. Add Events
6. Add Groups
7. Add Rules
8. Add Sites
9. Ad
10. Going “Live”

Publish a form

1. Click Forms in the Left Menu.
2. Locate the relevant form in the list, if necessary using the filtering and sorting features.
3. Click the Actions icon, then from the dropdown, click Publish.
4. On the Publish Form page, you can set a different version; this is recommended to indicate your changes are significant. Then click Publish.
5. A message will indicate whether or not the publication operation was successful.

If the form fails to publish, the following occurs:

1. An email is sent, reporting that the form that failed to publish.
2. The error from Captivate Live is displayed.

Note:

• You cannot change the form version using a mass publish action.  In a mass publish action, the major version string is unchanged and the minor version will be incremented.

Unpublish a Form

Once a form is published, it can be unpublished to remove it from Captivate Live. To unpublish a form:

1. Click Forms in the Left Menu.
2. Locate the relevant form in the list, if necessary using the filtering and sorting features.
3. Click the Actions icon, then from the dropdown, click Unpublish.
4. Click Unpublish again in the popup to confirm that you want to remove the form from Captivate Live.
5. If the CRF has associated clinical data, a similar pop-up window is displayed.  It gives you the option to Force Delete the clinical data, or keep it. This operation is not reversible. If you are unsure, click Keep Data.
   
6. When the form is successfully unpublished, its status reverts to Draft.

To delete a form, its status must be Draft:

1. Click Forms in the Left Menu.
2. Locate the relevant form in the list, if necessary using the filtering and sorting features.
3. Click the Actions icon
   
4. Click Delete to confirm that you want to delete the form.
5. The form is removed from the list.

Note:

• Delete is not a recoverable action.

From Users

In the user management area, you can mask forms to prevent some users to access them.

1. Select Users from the Left menu
2. Click the Action menu on the user you want to hide a form to
   
3. Next to the forms you want to Mask for this user, click Yes in the column Mask this CRF
   

Notes:

• Forms can only be hidden for the users with roles: Clinical Research Coordinator and Site Monitor as the other roles need full access to perform their functions.

From an Event

A form can be hidden in an Event to prevent it to be seen by anybody.

1. Select Events from the Left menu
2. Click on the Action menu and select Edit
3. On the Edit page, find the form you want to hide
4. Tick the Checkbox Hide CRF
   
5. Click Continue at the bottom of the page
6. Submit to save the changes

From a Site

A form can be hidden in a Site to prevent it to be seen in this site only independently from the other sites in the Study.

1. Select Sites from the Left menu
2. Click on the Action menu and select Edit
3. On the Edit page, find the form you want to hide in the section Update Site Event Definitions
4. Tick the Checkbox Hide CRF
   
5. Click Continue at the bottom of the page
6. Submit to save the changes

To view form details, its status must be Published:

1. Click Forms in the Left Menu.
2. Locate the relevant form in the list, if necessary using the filtering and sorting features.
3. Click the Actions icon, then from the dropdown, click View Details.
4. A similar page opens.

Icon	Description
	Links – Displays clinical data associated with the form, including discrepancy notes, rules, subjects and events.
	Print – Opens a new window displaying the form. Enter CTL-P to send the form to the printer
	Metadata – Displays the form, sections, groups and items metadata, including the relevant OIDs.
	Annotate – Display the annotated form.

Lock a form

Locking a form makes it unavailable for data entry or any other operations, except view. To lock a form, its status must be Published:

1. Click Forms in the Left Menu.
2. Locate the relevant form in the list, if necessary using the filtering and sorting features.
3. Click the Actions icon, then from the dropdown, click Lock.
4. Click Submit to confirm that you want to lock the form, or Back to cancel.
5. Click Yes in the confirmation pop-up.
6. The form is now locked.

Unlocking a form

Unlocking a form reverses its locked status.  To unlock a form, its status must be Locked:

1. Click Forms in the Left Menu.
2. Locate the relevant form in the list, if necessary using the filtering and sorting features.
3. Click the Actions icon, then from the dropdown, click Unlock.
4. Click Submit to confirm that you want to enable the form, or Back to cancel.
5. Click Yes in the confirmation pop-up.
6. The form is now unlocked.

To manage events:

1. From the Left menu, click Events.
2. A similar page is displayed.
   
3. Click the Actions icon to select the action to be performed.

The following actions can be performed on Events:

The More Menu includes:

• More Columns displays: event OID, Description, Reference, Day Min, Day Schedule, Day Max, and Day Email.
• Export exports the filtered events list.

Notes:

• The events are listed by order of appearance on the Subject Matrix.  For this reason, sorting is not available.  To re-order an event, click the Relocate icon at the beginning of the row then drag and drop the event in the desired order.  Make sure to collapse the CRF tree view before relocating an event.
• To reorder a form attached to an event, click the triangle icon in the CRFs column to expand the CRFs tree view. Click the Relocate icon at the beginning of the row then drag and drop the CRF in the desired order.  Make sure to drop the CRF within the event it belongs to. 
• To relocate a form between events, use Edit to delete the form from an event, then Edit the desired event to re-attach the CRF.
• You can filter the events list. The list will filter to include those matching the entered characters. To re-display the whole list, remove the characters in the filter boxes.

Build Steps:

1. 1. Add Study
   2. Add Forms
   3. Deploy Study
   4. Publish Forms
   5. Add Events
   6. Add Groups
   7. Add Rules
   8. Add Sites
   9. Add Users
   10. Going “Live”

Events are a series of site visits or clinical events during which patient data is collected over the course of a study. There are four types of events:

• Scheduled events are expected to occur at a pre-determined schedule, according to the study protocol.
• Unscheduled events do not have a pre-determined schedule. For example, an unexpected office visit.
• eSource events are similar to Scheduled events, but they allow you to collect data in real time. You do not need to collect data on a source document first.
• Common events collect data forms, but they are not expected to be associated with a particular time. Examples might include Protocol Deviations, Concomitant Medications and Adverse Events.
• Calendared events automatically schedule follow-up events based on a reference event, according to intervals set in the study protocol.

Add an event

1. Click Events in the Left Menu
2. Click the + icon in the Events page.
3. Complete the following. Required fields are marked with an asterisk.

4. Click Continue.
5. Select the CRFs to attach to the event by clicking the corresponding checkboxes.
   
6. Click Continue.
   
7. For each of the selected CRFs, complete the following.

8. Click Continue.
9. Review the Event to be defined.
10. If you’re satisfied, click Submit.
11. You can change the order the events will appear on the Subject Matrix by dragging and dropping the events in the order desired.
12. You can also change the order of the CRFs attached to an event by dragging and dropping a CRF in the order desired within the same event.

Repeat this process to create all the events with the associated forms, according to your study protocol.

Note:

• Event must be added after deploying a study.

To edit an existing event:

1. Click Events in the Left Menu.
2. Locate the relevant event in the list, if necessary using the filtering feature.
3. Click the Actions icon, then from the dropdown, click Edit.
4. Make any necessary changes to the event properties. Required fields are marked with a red asterisk.  See section Add Event for the configurable event properties.

Disable an Event

Disabling an event removes it from Captivate Live’s Subject Matrix.  To disable an event:

1. Click Events in the Left Menu.
2. Locate the relevant event in the list, if necessary using the filtering feature.
3. Click the Actions icon, then from the dropdown, click Disable.
4. Click Submit to confirm that you want to disable the event, or Back to cancel.
5. Click Yes in the confirmation pop-up.
6. The event is now disabled.

Note:

• To disable an event, its status must be published.

Enable an Event

Enabling an event reverses its disabled status.  To enable an event:

1. Click Events in the Left Menu.
2. Locate the relevant event in the list, if necessary using the filtering feature.
3. Click the Actions icon, then from the dropdown, click Enable.
4. Click Submit to confirm that you want to enable the event, or Back to cancel.
5. Click Yes in the confirmation pop-up.
6. The event is now available.

Note:

• To enable an event, its status must be Disabled.

To delete an event:

1. Click Events in the Left Menu.
2. Locate the relevant event in the list, if necessary using the filtering feature.
3. Click the Actions icon, then from the dropdown, click Delete.
4. Click Delete to confirm that you want to delete the event.
5. The event is removed from the list.

Note:

• Before deleting an event, the following conditions must be met:
  • The event does not have any forms attached.   Edit the event to delete any associated forms.
  • All events status must be not scheduled in Captivate’s Subject Matrix.
• Delete is not a recoverable action.

To manage groups:

1. From the Left menu, click Groups.
2. A similar page is displayed.
   
3. Click the Actions icon to select the action to be performed.

The following actions can be performed on Groups:

The More Menu includes:

• More Columns displays: Subject Assignment and Default.
• Export exports the filtered groups list.

Notes:

• For group details, click the black triangle icon to expand the groups’ tree view.
• You can filter the groups list. The list will filter to include those matching the entered characters. To re-display the whole list, remove the characters in the filter boxes.

Build Steps

1. Add Study
2. Add Forms
3. Deploy Study
4. Publish Forms
5. Add Events
6. Add Groups
7. Add Rules
8. Add Sites
9. Add Users
10. Going “Live”

Add a group

1. Click Groups in the left menu
2. Click the + icon in the Groups page.
3. Complete the following. Required fields are marked with an asterisk.

4. Click Continue.
5. Review the Subject Group Class to be defined.
6. If you’re satisfied, click Submit.

Notes:

1. Events associated with Dynamic Groups are shown on the left side of the Subject Matrix, starting with the group marked as the Default.
2. You can reorder the events within a Dynamic Group by clicking the up/down triangles.

To view a group:

1. Click Groups in the Left Menu.
2. Locate the relevant group in the list, if necessary using the filtering and sorting features.
3. Click the Actions icon, then from the dropdown, click View.
4. The group metadata page is displayed but you cannot make any changes to it.
5. When you’re done viewing the group, click Back.