What checks are performed during validation?
General validation checks
For a study to be deployed to Oracle InForm, it must pass a series of validation checks. For more information, see:
Validation area | Must be true for successful validation |
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Study objects |
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Locale and translation |
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Layout |
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Rules |
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Validation checks for Oracle InForm deployment
Validation area | Must be true for successful deployment to the InForm application |
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Study | The study has at least one study event. |
Study design | A warning occurs if the title or RefName of the study design, when appended with the version and locale of the study design, might exceed 63 characters. If the warning occurs, shorten the title or RefName, or the deployment process truncates the title or RefName in the Oracle InForm application. |
Common visit | For studies with common forms, if you translate a title or short title of the common visit for one language, the title and short title are translated for all languages. |
Study event |
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Form |
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Section |
For a regular section:
For a dynamic grid section:
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Item |
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Codelist and codelist item |
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Codelist subset |
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Review state |
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Workflow |
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Data-entry rule |
Note: If two rules (on different study objects) have the same name, in release 7.0 of the Oracle Central Designer application, you receive a warning during validation. Using the same rule name for rules on different study objects is not recommended, and future releases may not support the practice. |
Function |
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Unit |
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In-place revision |
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Study administration data |
General checks:
Item group checks:
Rights group checks:
Signature group checks:
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Other | Oracle reserved words are not used as RefNames of any study object or Aliases of data sets and data series. |
Validation for special Oracle InForm forms and items
Validation area | Error or warning |
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All special forms (Screening, Enrollment, Patient Identification, and Study Completion) |
Error if:
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Screening and Patient Identification forms |
Error if:
Warning if the special items are on a non-special form. |
Enrollment form |
Error if the:
Warning if the special items are on a non-special form. |
Study Completion form |
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DOV item |
Error if the item:
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Randomization item |
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Patient Initials item | Warning if the item has 4 characters. |
Drop Out Reason item | Error if the code for its codelist item has more than 47 characters. |
Validation for coding
To be valid, a study must pass the following coding-related checks:
- A form can contain only one copy of an item.
- Items in a coding map must all be either in or not in a repeating section.
- A coding map must include at least one target item.
- A target item must be a top-level item or a child of a top-level compound item. It cannot be a child of a nested compound item and cannot be conditional on another item.
- All query target items must be:
- Top-level items.
- Visible and available for editing in the Oracle InForm application. Items designated as query targets must not have the Display Override property set to ReadOnly or Hidden in the Oracle Central Designer application.
- All items in a coding map, except the query target item, must be text items.
- Each coding map is valid in the dictionary type from which it was created.
- The dictionary metadata in the study CSML must be in the dictionaries that are supported in the Oracle Central Designer application.
Validation for monitoring forms
If you create a custom regulatory document form and a visit report form, the following must be true for the study to pass validation:
- Only one regulatory document form and one visit report form exist in the study.
- (For visit report forms only) The form contains a Date of Visit item that is marked as a Date of Visit special item and is the first item on the form.
- If the study supports multiple locales, the regulatory document form and visit report form are translated for all locales. A warning occurs if the forms are missing translations for one or more locales.
- The visit report form is not repeating.
Validation for data mappings
The type of data mapping, either CDD, CIS, or rules, determines whether the data mapping definition is validated against criteria for CDD data mappings, CIS data mappings, or no data mappings, respectively.
Validation area | Must be true for successful validation |
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CDD data mappings | - |
Data type compatibility |
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Date part and split date | If any item is mapped to a data series with the split date option, all items mapped to the data series must use the split date option. |
Target key types |
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Data sets and data series | Custom dimensions and custom dimension labels do not reference deleted codelists or codelist items. |
CIS data mappings | - |
Block key and page key |
The block key and page key must conform to the specifications of the data series for the block key item or page key item in the context panel:
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Context panel |
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Data type compatibility |
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Date part and split date | If any item is mapped to a data series with the split date option, all items mapped to the data series must use the split date option. |
Enrollment panel | A data mapping can have only one enrollment panel. |
Non-patient data panel | The data series in a non-patient data panel cannot have any mapped items. |
Other validation for CIS data mappings |
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Data sets and data series | Custom dimensions and custom dimension labels do not reference deleted codelists or codelist items. |
Validation for in-place revisions
In order to validate an in-place revision, which compares the current potential baseline and previous baselines, baselines that have been deployed to LIVE/UAT must exist. For more information, see Delete a deployment package and Can I delete a validation baseline?
The following in-place revision changes cause validation warnings. If you make these changes using in-place revision, you must ensure that the changes do not result in data loss, do not compromise data integrity, and do not have regulatory impact.
- Reduce the length of an alphanumeric, numeric, or float study object.
- Reduce the minimum or maximum limit for a numeric or float study object.
- Remove an item for which data was entered in Oracle InForm.
Note:
Oracle Central Designer does not check whether data has been entered for a study in Oracle InForm. We recommend creating or using an existing manual process to determine whether data loss, data integrity or regulatory impact occurs. - Modify the precision for a numeric or float study object.
- Modify a codelist label.
- Decrease the date range for a date control.
- Remove a date part such as hours or minutes from a date control.
- Modify item text to correct spelling or punctuation errors.
- Add an item to an existing section.
- Remove or modify the codelist subset for a codelist on a form.
- Select a codelist subset for a codelist on a form.
- Remove a codelist item from a subset that is assigned to a codelist on a form.
- Remove a source from a dynamic grid.
The following in-place revision changes cause validation errors. You cannot deploy your study successfully if you make these changes by performing an in-place revision.
- Remove a unit selection for an item.
- Modify a codelist selection value.
- Modify a fixed repeating section by doing the following:
- Add an additional row.
- Change a predefined value.
- Remove a row.
- Rearrange rows.
- Change an existing item cell from non-blank to blank.
- Change an existing item cell from blank to non-blank.
- Add new items that have blank cells.
- Modify a dynamic grid section by doing the following:
- Change the section from dynamic to not dynamic.
- Remove an item from the source form or section referenced in the dynamic grid section, and apply the in-place revision to the source object, but not to the dynamic grid section.
- On the Design tab of the form or the Properties tab for the form, modify an item on the source form or section referenced in the dynamic grid section, and apply the in-place revision to the source object, but not to the dynamic grid section.
Note:
If you make these changes on the forms' Layout tab, you need to apply the in-place revision to the source object or the dynamic grid section, but not both. - Modify an item on the source form or section referenced in the dynamic grid section, and apply the in-place revision to the dynamic grid section, but not to the source object.
- Add an item to the source form or section referenced in the dynamic grid section, add the item to the dynamic grid section, and apply the in-place revision to the dynamic grid section, but not to the source object.
- Add a source form or section to the study, add its items to the dynamic grid section, and apply an in-place revision to the dynamic grid section.
Note:
This is not possible because, even though adding an item to a dynamic grid section is a supported in-place revision change, adding a form or section must be done by creating a new study version. You cannot deploy a study with both types of changes. - Change the type of item mapping (item level or data point mapping).
- Change the codelist item mapped for the source item, but that codelist item does not exist in a deployed version of the source, and in-place revision is applied to the dynamic grid but not the source.
- Codelist item used by a dynamic grid was removed and in-place revision applied to the source but not on dynamic grid.
- Codelist subset for an item in item level mapping does not match between source and target, and in-place revision is not applied both to the source and the dynamic grid.
- Modify the structure of a control by adding a level of nesting or changing a radio control to a pull-down control.
- Remove a special item.
- Add a section to a form.
- Remove a section from a form.
Validation for custom events
Validation area | Must be true for successful validation |
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Custom events |
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Custom event triggers |
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Custom event results |
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Custom event In-place revisions |
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Some information is not validated. For more information, see What information is not validated?
Parent topic: Validation