Creating and Defining a Clinical Component

Problem

You want to create a study or submission.

Solution

Studies and submissions are created using the New Clinical Component wizard. The wizard collects basic object metadata such as name, description, and content location in the metadata tree. Then, the wizard collects metadata about the clinical component. For example, a study collects metadata such as protocol title, indication, and phase. After metadata is collected, the versions of the data standards that can be used for the clinical component are defined.

Note: Only an administrator can set the default content for a clinical component using the Clinical Administration tree. For more information, see Adding Users to the Clinical Administrators Group.

Tasks

To create and define a clinical component, complete the following steps:

In the Folders tree, right-click on a folder, and select NewClinical Component. The New Clinical Component wizard opens. The General Information page appears.
In the Name field, enter a name for the clinical component. The name cannot be more than 60 characters in length.

Click Next.

The Clinical Component Type Selection page appears.
In the Description field, enter a description of the clinical component. The description cannot be more than 200 characters.
By default, the Location field is set to the folder in which you opened the New Clinical Component wizard. If you want to change the location of the clinical component, then click Browse, and then select a new location. The new location must not be an existing clinical component root folder or a subfolder of an existing clinical component root folder.
When the New Clinical Component wizard is opened, the Location field will default to your home folder My Folder if any of the following is true:
- No folder is selected.
- More than one folder is selected.
- An object is selected that is not a folder.
Click Next.

The Clinical Component Type Selection page appears.
Select a clinical component type from the list.

Note: The default selection is Study.
Click Next.

The Data Standards Selection page appears.
Select the data standards to apply to the clinical component. All active data standards to which you have access are displayed. You can select numerous data standards, or you can select none.
Click Next.

The Clinical Component Properties page appears.
Set the values for the properties of the clinical component type. The properties that are available on this page and their default values are predetermined by the administrator's configuration of the data standard’s property model.

Note: Do not use special characters in the properties fields. Special characters include single quotation marks, double quotations marks, and hyphens.
Click Next.

The Library Selection page appears.
Select one or more libraries to associate with the clinical component.

The libraries that are available on this page are predetermined by the default content for the type of clinical component that is being created.

Note: You do not have to select a library to create a clinical component.
Click Next.

The Controlled Terminology page appears.
To select a controlled terminology package to associate with the clinical component, click Add. The Available Terminology Packages window appears. The controlled terminology packages that are available, as predetermined by the administrator, are listed. Select a package, and click OK.

Note: If no controlled terminology packages are available, then a message is displayed.

To remove a selected controlled terminology package, click Remove. Then, click OK to confirm.

You do not have to associate a controlled terminology package with a clinical component.
Perform one of the following:
- If you are creating a clinical component, then click Finish.
- If you are creating a submission, then go to step 16.
In the Contributing Studies page, select the study or studies to associate with the submission. All studies to which you have access are displayed. You can select numerous studies, or you can select none. Click Finish.