Creating a Study or Submission

Overview

You create a study or submission by providing basic object metadata such as name, description, and content location in the metadata tree. Then, SAS Clinical Data Integration collects metadata about the item. 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 study or submission are defined.
Note: Only an administrator can set the default content for a study or submission. For more information, see Adding Users to the Clinical Administrators Group.

Folder Organization of Studies and Submissions

A study or submission can be located at the root of the hierarchy in the Folders tree (Study 1 and Submission 1 in the following figure) or within a general folder (Study 2 and Submission 2).
Illustration of Basic Folder Hierarchy
illustration of basic folder hierarchy
You can create more complex hierarchies based on the containment rules shown in the following table:
Folder Containment Rules
Content
Study
Submission
Container
Study
not allowed
not allowed
Submission
allowed
not allowed
Using the containment rules, here is an example of a complex folder hierarchy:
Illustration of Complex Folder Hierarchy
illustration of complex folder hierarchy

Name Requirements

A study or submission name has a maximum length of 60 characters.

Description Requirements

A study or submission description has a maximum length of 200 characters.

Create a Study or Submission

To create a study or submission, perform the following steps:
  1. In the Folders tree, right-click a folder, and then select Newthen selectStudy or Submission.
    The New Study or New Submission wizard appears.
    New Study wizard
  2. Enter a name and optional description.
    The name must meet the requirements; see Name Requirements. The description must meet the requirements; see Description Requirements.
  3. To change the location of the study or submission, click Browse, and then select a new location.
    For information about the location of a study or submission, see Folder Organization of Studies and Submissions.
  4. Click Next.
    The Data Standards Selection page appears.
  5. (Optional) Select one or more data standards.
    All active data standards to which you have access are displayed.
  6. Click Next.
    The Study Properties or Submission Properties page appears.
  7. (Optional) Specify the property values.
    The properties that appear 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 single quotation marks, double quotations marks, or hyphens in the property values fields.
  8. Click Next.
    The Library Selection page appears.
  9. (Optional) Select one or more libraries to associate with the study.
    The libraries that are available on this page are predetermined by the default content for a study or submission.
  10. Click Next.
    The Controlled Terminology page appears.
  11. (Optional) To select a controlled terminology package to associate with the study or submission, perform the following steps:
    1. Click Add.
      The Available Terminology Packages dialog box appears. The controlled terminology packages that are available, as predetermined by the administrator, are listed.
    2. Select a package, and then click OK.
  12. To remove a selected controlled terminology package, click Remove.
  13. If you are creating a study, click Finish.
  14. If you are creating a submission, click Next.
    The Contributing Studies page appears.
  15. (Optional) Select one or more studies to associate with the submission, and then click Finish.
    All studies to which you have access are displayed.
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