Details for study designers

When it comes to your workflow as a study designer, here's what's new for you:

• Users assigned the Manage Study Code Lists permission can access and modify a custom code list by adding new items, hiding items, changing the order of values, updating the code, and applying it to an existing question that previously had the code list applied to it (if assigned the Design Forms permission, as well), even if the study design has already been moved to Approved.

  Note:

  The Value and Label for any code list item assigned to a question in an approved study version cannot be modified.
• The newly applied code list must be the same, previously selected code list, that was originally associated to the question.

  • If you attempt to assign a code list to a question that is not the preexisting code list, the system displays the message alert:

    The following question is currently used in an approved study version. You can only modify and reload the existing custom code list for this question.

  • When the preexisting code list is applied to a question, the system displays the message:

    The following question is currently used in an approved study version. Any data previously collected will remain until updated by a system user.

• A different code list cannot be applied to an existing question once the study version has been moved to Approved.
• If you apply the new code list to a question that is used in a rule in the Design container, you must review the rules and ensure that they are not impacted.
• You are required to review and update your study's randomization design or dose calculations if hidden code values are used in stratification, dose calculations, or cohort management.

  Note:

  If you apply the updated code list to a question that is used as a branching question, none of the code list items can be hidden. Additionally, code values used in branching cannot be hidden.

More information on managing code lists can be found in the Sponsor and CRO User Guide and Study Designer User Guide after the Release Assessment Environment (RAE) upgrade.

Impact on reports, extracts, archives, and datasets

Now, the Study Design report reflects any code list modifications within the form's attributes.

When it comes to Oracle CRF Submit, be aware that when a label is changed and the Advanced Study Version is applied, discrepancies may occur between the user interface (UI) and the generated study version PDF.

You can find more information in the Reporting Guide after the RAE upgrade.