Create a coding question and coding target field

Create a coding question to let a site user collect a single piece of data that is automatically mapped to one or more fields from a coding dictionary.

You have to make sure a form also contains one or more read-only items that get automatically populated with translations of the coding question's answer. These read-only items can also be hidden and represent a coding question's coding targets.

You can include a coding question on any form, but you typically include a coding question in a repeating form for concomitant medications or adverse events. The Coding Item Type is unique for every question in the study. Also, each combination of the Coding Item Type and Dictionary Type should be unique within the study.

A coding question's answer is automatically translated to a dictionary term. To make sure that coding process happens, you need to define its coding properties in a certain way and all coding questions must be in a text format.

The question can either be a text or multiple-choice type of question (such as a question with radio buttons or check boxes). For example, for a Verbatim Term mapped to the MedDRA dictionary, the Verbatim Term can be a text question or a question with radio buttons. For Route of Administration or an Indication term mapped to the WHODrug dictionary, the question can be a drop-down.

Note:

Even though you can design a verbatim term as a question with checkboxes, you must avoid using this combination in study design. As a best practice, we recommend that you only include one verbatim term per question, for coding purposes. For example, if a verbatim term is defined as a multiple-choice question, the term would appear in Oracle Central Coding as | Advil | Aspirin |. That is because Oracle Central Coding has no way of separating a multiple-choice answers into separate terms. To correct this issue, an Oracle Central Coding user can create a query in Oracle Central Coding asking a study user to split the terms. However, to completely avoid this issue, you must always design a verbatim term as a text question or a question with a single option for an answer.

Task 1   Create a coding question

1. On the form, click Add Question, and select the type of question you want to create.
   • For text questions, if you expect site users to provide a long answer, select Multiple Line Answer. Enter a character limit, up to the default limit of 4,000 characters.
   • For multiple choice questions, enter as many answer options as you need. For a multiple choice question, only the selected answer is translated. For example, if a site user chooses option A as an answer, only the term listed as option A is translated.
2. On the right, expand the Details pane and enter a reference code for the question.

   A reference code is a one-word abbreviation for the question.

3. In the Question Hint field, provide site users with guidelines for data entry.

   Note:

   For more information, see Create Question Hint text.
4. If screening, randomization, and dispensation can't happen until a site user enters a valid answer for the coding question, or if the question is required to be completed for all subjects, make sure the Required toggle () is turned on.
5. To configure source data verification settings at a question level, see Configure source data verification settings.
6. Expand the Advanced pane and click Add Property.
7. From the drop-down, select Coding Question and fill-in the fields:
   • Dictionary: From the drop-down, select a type of dictionary that is used by Oracle Central Coding to search for the term that you want to translate.
   • Coding Item Type: From the drop-down, select a type of coding item to translate a coding question's answer.
   • Tag for Central Coding: From the drop-down, select a tag that categorizes your data in Oracle Central Coding.
8. Make sure the SAS properties are correctly defined for both the SAS Variable and SAS Label fields.

Task 2   Create a coding target

Answers for coding questions are automatically translated and displayed in a read-only type of field on a form called a coding target. To make sure your coding questions have a coding target field where their answers can be translated, you need to define one or multiple read-only and hidden items that will get populated with the coded term for a Verbatim Term, Indication, or Route of Administration.

For example, if you configure a text type of question as a verbatim term mapped to the MedDRA Dictionary, then you need to include a corresponding read-only item for it.

1. First, you must create a read-only item. For step-by-step instructions, see Create a read-only item.
2. Select the read-only item and expand the Advanced pane.
3. Make sure the SAS properties are correctly defined for both the SAS Variable and SAS Label.
4. Click Add Property, select Coding Question and fill-in the fields.
5. Repeat steps 1 to 4 for every read-only item you create in the form.
6. If you want to hide a coding target in a form, so site users no longer see it, turn on the Hidden toggle ().

   Note:

   Make sure the coding target field isn't Required, otherwise site users won't be able to complete the visit unless the coding target is immediately populated.
7. To configure data classifications for a hidden question, see Classify a hidden question.
8. To configure source data verification settings at a question level, see Configure source data verification settings.
9. To save the form, in the lower right of the form, click Save.

   Tip:

   If the Save button is disabled, make sure there are no blank questions on the form.