Definitions:

An Event is a group of Forms that are used in your Study. An event might or might not be connected to a real-world visit.

A Form or eCRF (electronic Case Report From) is a group of fields for collecting Participant data.

Examples:

An Event could be a follow-up visit that occurs during a study.

Form could be used to record a Participants vital signs, capture a patients informed consent, track drug accountability, etc.

Study Designer contains a set of features that allow you to define, configure, and manage Events for your Study.

Events

 Each Event can be Defined as One of the Following Types:

  • Visit-Based: An Event that is scheduled to occur within the study and is associated with a visit date.

  • Common: An Event that isn’t necessarily associated with a visit but may occur any time throughout the study.

In a typical clinical trial, most Events are defined as Visit-Based Events, such as: Week 2, Week 6, and Monthly Follow-up, in which the Week 2 visit occurs two weeks after the Baseline visit, the Week 6 visit occurs six weeks after Baseline, etc. These visits are associated with a schedule that is outlined in the Study protocol, and each visit has a specific set of Forms that are collected.

Common Events are used to collect information that is not necessarily related to a scheduled visit date. For example, Adverse Event (AE), Concomitant Medication (ConMed), or Early Termination Events.

Common Events can be defined as either Repeating Events (e.g. AEs and ConMeds, since Participants might have more than one AE or ConMed) or Non-Repeating Events (e.g. Early Termination, since a Participant can only terminate once.)

Icons

In Study Designer, one or multiple icons appear after the name of the Event.

IconEvent TypeDescriptionExample(s)
Visit-BasedAn event that is associated with a visit date. The event can be repeating or non-repeating.Week 2 Visit (non-repeating);
Monthly Follow-Up for Disease-Free Survival (repeating)
CommonAn event that is not necessarily associated with a visit date.Early Withdrawl or Termination (non-repeating);
Adverse Events (repeating)
RepeatingAn event that repeats in your study, either a known or unknown, number of times.
This icon will appear adjacent to one of the previous two when an event is a repeating event.
Concomitant Medications

To Add an Event to a Study:

  1. Click +Add an Event.
  2. Enter a name for your Event.
  3. To edit details, click on the name of the Event.
  4. Enter values into fields, as needed.
  5. Click the Save button.

To Edit Settings for an Event/Form:

  1. Click the name of the Event.
  2. Change settings as needed.

Warning: Once you have moved your study to Production, you cannot change the Event to Repeating/Non-Repeating or Visit-Based/Common.

To Copy an Event:

  1. Click on the Menu button next to the name of the Event.
  2. Select Copy.

Note: When you copy an Event, any changes you make to one Event is applied to the copy.

To Archive an Event:

  1. Click on the Menu button next to the name of the Event.
  2. Select Archive.

Note: Archiving an Event removes the Event and all associated Forms from the study. If a study was previously published, the Event was archived, and the study was republished, that Event is no longer available within the study. However, archived Events can be restored at any time. If data was entered prior to the Event being archived, when a user views a Form in the Event This event has been archived appears at the top of the Form.

To Restore an Event:

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

Note: Restoring an Event restores all its Forms. You can restore an Event with only a specific Form by clicking the Restore button next to the Form.

Forms

You can use Form Designer, a drag-and-drop interface that allows you to add questions and other item types to your Form, or you can use the Form Template, a pre-formatted XLS spreadsheet that allows you to enter data for your Form.

If you use Form Designer, you can add questions manually or select questions from the Content Library.

If you use the Form Template, you can either start with a blank Form Template and add data, or download a Form from Samples Forms, which you can either edit or use as is. 

You can also use both Form Designer and the Form Template. 

Warning: If you use both, be aware that if you start with a Form Template, edit the Form in Form Designer, and then try to download the XLS spreadsheet again, it will be formatted differently from the original.

For more information on creating Forms, see Using Form Designer or Using the Form Template.

To Download the Form Template:

In Study Designer, click the Form Template button in the header to download the Form Template.

Best Practice: If you have previously downloaded the Form Template, make sure to download it again to get the most recent version.

To Upload a Form Definition Spreadsheet:

  1. Click the Form card.
  2. Click the Upload button to upload a Form.
  3. (Optional) Click the Preview button to preview a Form.

To Enter Form Designer:

  1. Click the Form Card.
  2. Click the Design button.

To Preview a Form:

Click the Preview button on the Form card to view and test your Form, including edit checks, conditional fields, and calculations.

Note: Cross-form logic does not function as it does in Study Runner (i.e. the published study). You cannot save data in Preview mode, and the Close and Complete buttons do not appear.

If the Participate Module has been activated, and you select the Form Property of Participate Form, this option appears as Preview (as a Participant).

To Copy a Form to another Event:

  1. Click the Form card.
  2. Click the Menu button in the corner of the Form.
  3. Select Copy To.

To Archive a Form:

  1. Click the Form card.
  2. Click the Menu button in the corner of the Form.
  3. Select Archive.

Note: Archiving a Form removes the Form from the associated Event. The same Form can be used for multiple Events. In this case, archiving the Form in one Event does not have any impact on the Form in another Event. You can view archived forms in the study but they are no longer available for edit. Data in archived forms is not included in extracts

To Restore a Form:

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

To Restore a Form Version:

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

Form Properties

Forms can be Hidden, Required, and/or a Participate Form.

IconForm PropertyDescriptionExample
HiddenThe Form is hidden at the site level but is accessible from the study level.This is usually used when you want to import data rather than entering it directly in the user interface to prevent site users from viewing or changing data.
RequiredThe Form must be completed in order for the Event to be completed.A Participant would be required to complete a consent Form to participate in the study.
Participate FormAllows the Participant to enter their own data with the use of OpenClinica Participate. (This checkbox is not available if the Participate module has not been activated.)A Participant might be asked to complete a questionnaire to evaluate potential side effects of a new medication.
(No Icon)Allow Add AnotherAllows the user to add a new instance of a Form in a common repeating Event. If the user clicks the Add Another checkbox, when they click Close or Complete, another instance of the Form automatically appears.A user might need to document multiple Concommitant Medications.

To Set Form Properties:

Click the checkboxes on the Form Card.

Best Practice:

Use Permission Tags instead of setting the Form to Hidden for more flexibility.

SDV Requirements

Forms may or may not require SDV (Source Data Verification), depending on the study protocol.

IconSDV RequirementDescription
(No Icon)Not ApplicableSDV is not applicable for this Form.
Not Required (Default)SDV is not required for the Form. SDV is not required for the study, but you can still perform SDV if you want. This is often used when 10% of Forms need to be SDVed.
Partial RequiredSome fields on the Form must be verified.
100% RequiredEvery field in the Form must be verified.

To Set SDV Requirements:

Click the drop-down menu next to SDV on the Form Card and select the requirement level you want to apply to the Form.

Form Drafts and Versions

When you initially upload a Form Template, your Form automatically becomes a version. This appears under Versions on the Form Card. 

You can make changes to the Form Template and upload new versions or overwrite the existing version.

When you create a Form in Form Designer and save it, it becomes a draft and appears under Drafts on the Form Card. You can make changes as needed, and if you have multiple drafts, the most recent draft is moved to the top of the list with the label, (latest).

When You Create a Draft, it Does Not:

  • Create a new version
  • Appear when you publish your study
  • Appear in the Activity Log

You can promote the draft to a version to include it in your study when you publish it.  

Warning: If you do not want the new Form to overwrite an existing Form, make sure to change the number in the Version number field on the Layout & Settings panel in Form Designer. 

Once a Form has been published to Production, it cannot be overwritten. You must create a new version, or an error appears.

Drafts

To Access the Drafts Menu:

Click the Menu button under Drafts to access a list of Version Options

To Add a Draft to Your Study/Make the Draft a Version:

  1. Click the Menu button next to the draft you want to add to your study/promote to a version.
  2. Select Add to Study.

To Edit the Draft in Form Designer:

  1. Click the Menu button next to the draft you want to edit in Form Designer.
  2. Select Design.

To Upload Media & External Lists: 

  1. Click the Menu button next to the draft you want to upload media and/or external lists to.
  2. Select Upload.

To Download the Draft:

  1. Click the Menu button next to the draft you want to download.
  2. Select Download.

Warning: If you upload the Form Template, edit it in Form Designer, and then download the form, the spreadsheet will be formatted differently from the original.

To Permanently Delete the Draft:

  1. Click the Menu button next to the draft you want to permanently delete.
  2. Select Discard.

Versions

To Access the Versions Menu:

Click the Menu button under Versions to access a list of Version Options.

To Edit the Version in Form Designer:

  1. Click the Menu button next to the version you want to edit in Form Designer.
  2. Select Design.

To Preview the Version:

  1. Click the Menu button next to the version you want to preview.
  2. Select Preview.

To Download the Version:

  1. Click the Menu button next to the version you want to download.
  2. Select Download.