InForm and Clintrial custom properties

The following InForm and Clintrial custom properties are available by default in the Custom Properties workspace.

Note:

You must not delete InForm or Clintrial custom properties, or deployment is likely not to succeed.

For a list of CDD and CIS custom properties, see the User Guide.

Table 5-9 Descriptions and default values of custom properties

Study object Custom property Description and default values
Miscellaneous custom properties - -
Study Design Sponsor Name of the sponsor of the study.
- Sponsor Date Date specified by the sponsor of the study.
- Generic Drug Name Generic name for a drug.
- Sponsor Drug Name Code name given to a drug by a sponsor.
- Trade Drug Name Commercial name of a drug.
InForm custom properties - -
Study Design Shared Form Block Key Block key to use for a shared form. You must use this property if the block key in the Clintrial application is defined as a numeric field. The block key that you specify overrides the internal text block key (CommonCRF) that the Oracle Central Designer application creates during deployment from the system RefName of the special visit for shared forms.
Study Event Optional True or False (default), indicating whether the formset (visit) is optional or required.
Form Special Visits

Indicates if the study event holds a Screening or Enrollment form.

  • None (Default; study event does not have a Screening or Enrollment form).
  • Screening.
  • Enrollment.
- Item Required True (default) or False, indicating whether the item is required.
- SDV Required True (default) or False, indicating whether the item requires source verification.
- Special Forms

Forms that have special processing in the InForm software.

  • None
  • Screening
  • Enrollment
  • Patient Identification
  • Study Completion
  • (Available only in the NonClinical container) Reg Docs
  • (Available only in the NonClinical container) Visit Report
- SDV Critical True (default) or False, indicating whether the item requires source verification.
Item Display Override

Determines the default behavior of an item when a layout is generated.

  • ReadOnly—The item is visible but not editable.
  • Editable—The item is visible and editable by any user, regardless of the rights assigned to the user.
  • Hidden—The item is not visible.
  • None—The item is visible to all users, and visible and editable by any user who has the rights to view and/or edit the item.
- Item Required True (default) or False, indicating whether the item is required for data entry on the form to be complete.
- SDV Required True (default) or False, indicating whether the item requires source document verification.
- Special Fields

Fields used on the special forms for the InForm application.

  • None—Field is not a special InForm field.
  • Screening form:
    • Initials
    • DOB
    • Screening date
  • Enrollment form: Patient No.
  • Patient Identification form: Initials
  • Study Completion form:
    • Completion status
    • Drop out reason
  • Date of Visit form: DOV
  • Randomization form: Randomization field
- MinValue Minimum value that the InForm application will allow to be typed for the item.
- MaxValue Maximum value that the InForm application will allow to be typed for the item.
- MinProperty True or False, indicating whether MinValue is inclusive of the number typed.
- MaxProperty True or False, indicating whether MaxValue is inclusive of the number typed.
- SDV Critical True (default) or False, indicating whether the item is marked as critical.
Codelist Item Study Completion Status Items

Codelist items in the codelist for the Completion Status item on the Study Completion form, which is used in reporting in the InForm application to determine whether a subject dropped out of a study. Options include:

  • None—(default) The codelist item is not part of the codelist for the Completion Status item.
  • Complete Study (Study Completion)—Indicates that the subject has completed the study.
  • Incomplete Study (Study Completion)—Indicates that the subject has not completed the study.
Clintrial custom properties - -
Study Event Repeats Limit Maximum number of times a block can repeat. Set to -1 for unlimited repeats.
Form Verifiable

Indicates whether the panel needs to be verified in the Clintrial application.

  • 0—(default) Verification is not required before data in the panel can be validated.
  • 1—Verification is required before data in the panel can be validated.
- Protected

Indicates if the panel is protected in the Clintrial application.

  • 0—(default) Panel is not protected.
  • 1—Panel is protected.
- MaxRepeats Maximum number of repeating records that are allowed in a page section.
- Type

Type of panel in the Clintrial application.

  • 0—Type 0 panel (non-patient data).
  • 1—(default) Type 1 panel (one record per patient).
  • 2—Type 2 panel (more than one record per patient).
  • 3—Type 3 panel (one record per patient visit).
  • 4—Type 4 panel (more than one record per patient visit).
  • 5—Type 5 panel (subject enrollment).
- Audit Start

Default audit start point for all protocols in the Clintrial database instance.

  • ENTRY—Auditing begins after data has been entered interactively in a record.
  • VERIFICATION—Auditing begins after data has been re-entered to check the accuracy of the entry or, for batch-loaded records, after data has been screened.
  • VALIDATION—Auditing begins after a record has been validated, regardless of whether the record passed or failed validation.
  • VALIDITY—Auditing begins after a record has passed validation.
  • MERGE—Auditing begins after data has moved from the update table to the data table.
Item SAS Name Name of the item when data is sent to a SAS dataset through the Clintrial SAS interface. This attribute must be no more than eight characters, and it must conform to SAS requirements.
- Required
  • Selected—Value for the item must be supplied (for example, by the data-entry operator, or as a derived item) in the Clintrial application.
  • Not selected—Value is not required in the Clintrial application.

Note: If Required is True, Derived must be False. If Required is False, Derived must be True.

- Thesaurus Name of the thesaurus used to code the item.
- Derived

Indicates that the value of the item is calculated from a derivation associated with the panel.

Note: If Required is True, Derived must be False. If Required is False, Derived must be True.

- Min Minimum value that can be entered for the value of the item in the Clintrial application.
- Max Maximum value that can be entered for the value of the item in the Clintrial application.