Creating Study Specifications


With Vault EDC Studio, you can easily generate study documentation at any point in the design process. In the current release, there are three types of study specifications available: an All CRF PDF, a Unique CRF PDF, and an SDS, or Study Design Specification (Excel™).

All & Unique CRFs

You can create a PDF file containing all case report forms, or CRFs, in your study. You can choose to include annotations during creation. Annotations include additional detail about item fields on the form, such as coded values, maximum lengths, or if an item field is required.

The PDFs generated for both All CRF PDFs and Unique CRF PDF mirror the blank detail PDFs, available in other areas of the EDC application.

There are two types of PDFs available:

  • All CRF PDF: Forms are ordered by their appearance in the study schedule and repeat for each Event they occur in within the schedule.
  • Unique CRF PDF: Forms are ordered alphabetically and do not repeat even if they are used more than once in the study schedule.

Annotations

You can choose to include General Annotations and Export Annotations in your PDF:

General Annotations

In the current release, Vault adds the annotations described in the table below. Note that values surrounded with curly brackets (for example, {minimum value}) are tokens and will be replaced with the actual value from your study design.

Annotation Description
External ID= Displays the External ID (formerly known as OID) value for each design component.
Codelists: Each Codelist Item annotation includes the coded value for that option. This indicates the stored value that rules evaluate against.
Codelist Style: Radio Buttons - Horizontal Displays when the codelist-type Item uses horizontal radio buttons.
Codelist Style: Radio Buttons - Vertical Displays when the codelist-type Item uses vertical radio buttons.
Max Length: The Maximum Length set for a text-type Item field.
Max Length.Precision The Maximum Length and Precision set for number- and unit-type Item fields.
Read Only This annotation displays on any Read Only type Items.
Related Item for Coding This annotation displays on any Items marked as Related Items for a coding verbatim.
Required This annotation displays on any Items that have the Required property checkbox selected.
Range, {minimum value} - {maximum value} This annotation displays on any Items with both minimum and maximum range properties set.
Range must be >= {minimum value} This annotation displays on any Items with a Minimum Value property set.
Range must be <= {maximum value} This annotation displays on any Items with a Maximum Value property set.
Verbatim for Coding (Dictionary = {Dictionary Name}) This annotation displays on any Item used as a Verbatim for coding.

Export Annotations

This option adds an annotation to each Item in the PDF that indicates where that Item is included in the Main Study Extract CSV. For example, the Date of Birth item may have an annotation Demographics.DOB. In this example, the item is in the Demographics form’s view, in a column labeled “DOB”.

Study Design Specification (SDS)

The Study Design Specification (SDS) is an Microsoft Excel™ workbook. That workbook contains worksheets for key study design components:

  • Schedule - Grid: Lists all Form Definitions within the Study in the order that they appear in the study schedule.
  • Schedule - Tree: Lists all Event Group Definitions, Event Definitions, and Form Definitions, grouped together in the order that they appear in the study schedule.
  • Form Definitions: Lists each Form Definition within the Study, with columns for all form-related properties.
  • Codelists: Lists each Codelist Definition within the Study as a header row, with rows for each Codelist Item Definition for a codelist.
  • Unit Codelists: Lists each Unit Definition within the Study as a header row, with rows for each Unit Item Definition for a unit.
  • Rules (Optional): Lists each Rule Definition within the Study, with columns for rule details (such as the rule expression) and properties.
  • Study Settings: Lists the configured settings for the Study, including the Standard Date Format, the Subject ID Gen Format, and more.
  • Medical Coding Items (in vaults where Vault Coder is enabled): Lists all configured Medical Coding Item Definitions within the Study.
  • Primary Export View (Optional): Lists all of the columns in the Study Data Extract view set for the Study.

Scope

You can choose to Include Rules and Include Export during SDS generation. This adds the Rules and Primary Export View sheets to your Excel™ file.

How to Create Study Specifications

To create study specifications:

  1. Navigate to your Study in Studio.
  2. Optional: To generate a specification for a casebook version that is not the most recent version, select that version from the Actions menu.
  3. Select Create Specification from the Actions menu.

    Create Specification action

  4. In the Create Specification dialog, select one or more checkboxes to indicate the type of documentation to generate (All CRF PDF, Unique CRF PDF, Include SDS). Create Specification dialog

  5. Optional: Below each selected type, select checkboxes to expand the scope, such as including annotations or rules. See details about scope options for PDF and SDS. Create Specification dialog with Scope Selections

  6. Click Save.
  7. Vault begins a job to generate your study specifications. When finished, Vault sends you a notification with a link to download the file.

Which permissions control your access depends on when your vault was created. If your vault uses the Role by Study feature, see the first section, Role by Study Permissions. If your vault does not use the CDMS Role by Study feature, see the second section, Profile Permissions.

Role by Study Permissions

Users with the standard Vault Owner or Design security profiles can perform the actions described above by default. If your vault uses custom security profiles, you must have the permissions described in the Profile Permissions table.

Profile Permissions

Users with the Vault Owner security profile are automatically able to perform the actions described above.

If your vault uses custom security profiles, you must have the following permissions:

Type Permission Controls
Security Profile Tabs: Studio Ability to access the Studio tab in Vault EDC

Learn more about permission sets.


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