The following sections provide an introduction to basic information you’ll need to use OpenClinica:

1.2.1 Adding a Participant

Great! Now that you’ve logged in, let’s add a participant.

To Add a Participant:

  1. On the Participant Matrix screen, click the Add New Participant link above the matrix.

  1. Enter a Participant ID on the Add New Participant screen. (This should be a unique identifier, e.g. 001). If your study is set to auto-generate, an ID based on a pre-defined template appears.
  2. Click the Add button.

1.2.2 OpenClinica Navigation

Now let’s take a quick tour of OpenClinica.

There are two main areas in Openclinica: Study Build System and Study Runner.

Only Data Managers and Administrators can access the Study Build System. This includes:

  • The My Studies screen
  • Study Designer
  • The User Roles screen
  • The Settings screen
  • The Modules screen
  • The Share screen

All users can access Study Runner, but the Home screen depends on User Role, as does access to certain features.

Study Runner Includes:

  • The Home screen, which can be the Welcome screen, Participant Matrix, or Source Data Verification screen
  • The Participant Details screen
  • The Queries screen
  • The Study Audit Log
  • The Tasks menu and associated tasks
  • The User menu

The Header Bar Displays:

  • The study name
  • The study ID
  • The environment the study is in
  • The Change, Share, and Settings buttons. (Only users who are Data Managers and Administrators see the Design button.)
  • Participant ID Search
  • Links to menus and areas in Study Runner

The Panel on the Left Displays:

  • Alerts & Messages
  • Instructions
  • Info
  • Quick Links
  • Icon Key

1.2.3 The Participant Matrix

The Participant Matrix displays Participants in the study. This screen is central to the system.

Use the Participant Matrix to:

  • Manage Participants:
    • Edit Participant Data
    • Add a Participant
    • Remove a Participant
    • Restore a Participant
    • Sign a Participant Record (Investigators and Data Specialists Only)
    • Reassign a Participant to Another Site (Data Managers Only)
  • Schedule Events
  • View Participant Details
  • View, Enter, or Edit Data (depending on access)

The Participant Matrix lists Visit-Based Events across the top of the matrix and Participant IDs down the side.

Each icon represents the status of the Participant/Event combination. A legend of the icons is listed on the left side of the screen.

Hover over the icons in the Participant Matrix to see more details about the Event.

Filters

You can filter Events by the data in any column with a gray box under the header.

  • Use the drop-down menu at the top of the Participant Matrix to view Participants by Event.
  • Click the gray box in the Status column (which appears only if you click Show More) to view Participants by status, including the independent statuses of Locked and Signed. You can also filter Events with Not Locked and Not Signed.

View and Enter Data

Click the View button in the Actions column that corresponds to the Participant/Event to view the Participant Details screen.

Click the icon for a scheduleddata entry started, or completed Event and select View/Enter to view the Participant Details screen.

Edit Event

Click the icon for a scheduled or data entry started Event to edit the Event.

1.2.4 The Participant Details Screen

This screen displays the Participant’s general information, Events, and Forms.

Depending on Access, you can:

  • View Forms
  • Enter data into Forms
  • Edit Form data
  • Lock Events
  • Remove/Restore Events
  • Clear Forms
  • Reassign a Form to another version

To Access the Participant Details Screen:

On the Participant Matrix, click on the Participant ID or the View button that corresponds to the Participant whose information you want to see.

The Participant Details Screen

The Screen is Divided Into the Following Sections:

  • General Information
  • Visit-Based Events
  • Common Repeating Events
  • Common Non-Repeating Events

Custom Views

The Participant Details screen initially opens with the Visit-Based Events displayed and all Common Events collapsed. Click the Expand All link to expand all Common Events, or click an individual Common Event section to expand only that section.

When you expand sections, the Custom View On button appears. To return the screen to its default state, click the Custom View On button.

The General Information Section Displays Information About:

  • The participant
  • The study
  • The site
  • The participant status

 

1.2.5 Events

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.

IconEvent TypeDescriptionExample(s)
Visit-BasedAn event that is associated with a visit date. The event can be repeating or non-repeating.1 Month Follow-Up
Common RepeatingAn event that is not necessarily associated with a visit date and can occur more than onceAdverse Event
Concomitant Medications
Common Non-RepeatingAn event that is not necessarily associated with a visit date and only occurs onceTermination

Scheduling an Event

Once a Participant has been added, you can schedule Events.

You can schedule Events from the Participant Matrix, Participant Details screen, or the Tasks menu.

To Schedule an Event from the Participant Matrix:

  1. Click on the Schedule button for the Participant and the Event that you want to schedule.
  2. Select Schedule.
  3. Select a Study Event Definition from the drop-down list.
  4. (Optional) Select a Start Date/Time. The current date is the start date by default, but you can change it.
  5. (Optional) Select an End Date/Time.

Visit-Based Events

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

However, some Events, such as Adverse Events, Concomitant Medications, or Early Termination, do not occur on schedule and might not be associated with a visit date. These Events should be defined as Common.

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 forms.

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.)

Event Statuses

The table below displays Event statuses:

IconStatusDescription
Not ScheduledThe Event has not been scheduled. Common Events, such as Adverse Events remain in this status throughout the study.
ScheduledThe Event has been scheduled, but no data has been entered.
Data Entry Started
A user has started to enter data, but not all of the Forms in the Event have a status of completed.
CompletedA user has completed data entry for at least one Form in the Event. If further changes are needed in that Form, you are required to provide a reason for change.
SkippedThe user has decided not to complete the Event. Any data that has been entered can still be viewed and/or exported. You can select this setting from the dropdown menu on the Update Event screen when the current status is scheduled.
StoppedThe Participant has temporarily stopped participating in the study. You can select this status from the dropdown menu on the Update Event screen when the current status is data entry started.
RemovedThe Event has been removed. Users can still view Forms. This will supersede any of the other statuses.

Event Attributes

Event Attributes (or Independent Status Attributes) can be used in addition to Event statuses.

IconStatusDescription
SignedThe Event has been signed. This icon appears in addition to the status.

Note: If an Event is signed, changes to an item in a Form in that Event removes the signature. This also occurs if an Event status is changed from completed, stopped, skipped or not scheduled after being signed. In addition, this changes the Participant Status from signed to available and the Event Status to completed.

Archiving/unarchiving or removing a Form will unsign the Event. The exception is that when archiving/unarchiving, a Form with a status of Not Started will not be unsigned.

Multiple users can sign an Event, so even if an Event has already been signed, the sign action will still be available. If there are multiple signatures, the most recent one appears on the Form, and the others appear in the Audit Log.
ArchivedThe Event was archived in Study Designer. This icon appears in addition to the status.
LockedA Data Manager locked the Event. No data can be added, and the Event cannot be removed. This icon appears in addition to the status.

Event Actions

Only Data Managers can use the Reassign CRF action, and only Investigators and Data Specialists can use the Sign action.

IconActionDescription
Enter/EditEnter or edit data in the Form.
ViewView data in the Form.
RemoveRemove the Form from the Event. This is not permanent.
RestoreRestore a Form that was previously removed. All data is restored.
Clear Form
Clear all data in the Form. This resets the Form to Not Started and closes all associated queries, but audit history is retained.
Reassign CRF VersionChange the version of the Form if data has already been entered.

1.2.6 Viewing and Entering Data on Forms

Next, let’s explore how to view and enter data.

Features

The features of OC4 data entry include the following:

  • Participant Matrix: Easily see the data entry status of participants.
  • Auto-save: Automatically save during data entry.
  • Conditional field display: Only see relevant fields during data entry.
  • Automatic calculations and edit checks: Automatically use calculations and checks.
  • Queries: Easily create or view queries.

Forms

Forms are a collection of data entry fields for an Event or multiple Events. For example, the First Visit Event might contain the Eligibilty, Consent, and Demographics Forms.

Types

There are different types of fields, such as: select one, select multiple, integer, date, image, etc. Note that All changes saved appears at the bottom of the Form because all changes are saved automatically.

Layout

Forms can be simple (with one question per row) or grid (with one or multiple questions per box).

Conditional Fields

Some fields only appear if you enter a specific response in another field. For example, if the response to Do you smoke? is No, no related fields appear. If the response to Do you smoke? is Yes, other fields such as Packs per day might appear.

Edit Checks

If you enter a value that is invalid due to a constraint or do not respond to a required field, a message appears on the Form.

Closing or Marking a Form Complete

When you are finished entering data, you can close a Form and continue to enter data later or mark the Form Complete.

Before You Enter Data

  1. Add a Participant
  2. Schedule an Event

Entering Data

To Enter Data Directly into Visit Event Forms:

  1. On the Participant Details screen, click the Enter/Edit button in the Actions column to open the Form.
  2. Enter information into each field.

To Enter Data Directly into Common Event Forms:

  1. On the Participant Details screen, click the Common Event header to expand it.
  2. Click the Add New button or to enter data in an exisisting Form, select the Edit icon.
  3. Enter information into each field.

To Continue to the Next Page or Back to the Previous Page of the Form:

Click the Next button to proceed on the Form, and click the Back button to return to the previous page of the Form.

To Close the Form and Continue Data Entry Later:

Click the Close button.

Mark Data Entry Complete:

Click the Complete button.

Queries

Queries are inquiries or alerts about incorrect data.

The system creates queries automatically if you close a Form that has unaddressed errors or you can manually create a query.

Another user can respond to it and/or change the response in the field. Only Data Managers and Monitors can close queries.

Add a Manual Query:

  1. Click on the Query Bubble next to the field you want to inquire about.

  1. Click +New.
  2. Enter text in the Add a New Query text box.
  3. (Optional) Select a user to assign the query to.
  4. (Optional) Check the Email? box to send an email notification.

Allow the System to Automatically Create a Query for the Value in Question:

  1. Click the Close button on a Form.
  2. Click the Proceed button.
  3. The system auto-generates a query based on the default message text defined in the Form.

1.2.7 Your Home Screen

Your home screen depends on your User Role, as shown in the table below:

User RoleHome ScreenDisplays
Data Manager/AdminWelcomeGraphs of Study Progress
InvestigatorParticipant MatrixParticipants and Events
Clinical Research CoordinatorParticipant MatrixParticipants and Events
Data SpecialistParticipant MatrixParticipants and Events
Data Entry PersonParticipant MatrixParticipants and Events
Study or Site MonitorSource Data VerificationForms to Review and Verify
Study or Site ViewerParticipant MatrixParticipants and Events

Note: If you have a custom User Role, the role is still based on one of the existing roles. For example, instead of the Monitor role, there might be Monitor Site A and Monitor Site B. These are based on the Monitor role and have the same home screen and permissions.

1.2.8 Managing Your Account

All users can update their user profile and password at any time.

To Edit Profile Information:

  1. From the User menu, select My Profile.
  2. Click the Edit link, and update your information as needed:

Note: You cannot change the email address associated with your account. Please contact your administrator if you need to change your email address. To change your password, click the Change Password link, and update your password.

1.2.9 Frequently Used Screens

The screens you most frequently use depend on your User Role. Below are descriptions of the five main screens in OpenClinica.

ScreenDescriptionScreenshot

(Click the image to see a larger view)
Participant MatrixThis screen displays a list of participant IDs, events, and event statuses. From this screen, you can view participant details, schedule events, remove/restore participants, and reassign participants to another site, depending on access.


  • The Participant Matrix lists visit-based events across the top of the screen and participant IDs down the side.

  • Each icon represents the status of the participant/event combination.

  • A legend of the icons is listed on the left side of the screen.

  • Hover over the icons in the Participant Matrix to see more details about the participant event.

  • Click an icon for options to view and/or edit data, depending on your access.

  • You can filter events by status.

Participant DetailsThis screen displays the participant's general information, events, and forms. From here you can view Forms, enter data into forms, edit form data, lock events, remove/restore events, clear forms, and reassign a Form to another version, depending on access.

The Participant Details screen is divided into the following sections:

  • General Information

  • Visit-Based Events

  • Common Repeating Events

  • Common Nonrepeating Events

Form Data EntryWhen you open a form, you can view, enter data, edit data, add queries or annotations, close, and complete forms. If a user makes a change to the data after the form has been completed, they must enter a Reason for Change.

Some features include:

  • auto-save

  • conditional fields

  • calculations and edit checks

  • concurrency locking
QueriesThis screen displays all queries in the study environment. On this screen, you can view, add, update, and close queries, depending on access.

Queries are usually added while reviewing forms from the Participant Details screen, but you can also add them when reviewing forms here.
Source Data VerificationOn this screen, you can view forms, view item data, and verify/unverify forms.

1.2.10 Frequently Used Terms

The following table displays terms that are frequently used within OpenClinica.

QuestionAnswer
What is a study?A study is a collection of Forms and Events that contain participant data.
What is a participant?A participant (or a subject) is a person who provides data for the study. If the Participate Module is activated, participants can enter data. If the Randomize Module is activated, participants can randomly assign groups, such as placebo and non-placebo without the bias of demographics, sex, gender, age, etc.
What is an Event?Every Event has at least one Form. An Event can be visit-based, a scheduled occurence, or common, an unscheduled occurence. Events can common events can also be repeating or non-repeating.

Examples:
Visit-Based: One Month Followup
Common Repeating: Adverse Event
Common Non-Repeating: Termination
What is a Form?A Form (or CRF) is an electronic record of participant data. Each Event has at least one Form. You can enter data into a Form, depending on your access.

Forms can have conditional fields that only appear as a result of selecting specific responses or include calculations.

Data Managers create Forms in Study Designer. If the Participate module is activated, they can make the Form a Participate Form, which allows participants to enter data from their device.

What is Study Designer?Study Designer is where Data Managers create Events and Forms.
What is Study Runner?Study Runner is the application for using the study, either in Test or Production. Depending on acces, you can view/enter data, create queries, verify, import data, extract data, etc.

1.2.11 How to Log Out

You can log out of OpenClinica from the User menu.

To Log Out of Openclinica:

  1. Click the User menu.
  2. Click Sign Out.