Form and validation rule FAQs

• Can multiple study designers edit a study at the same time?
  Multiple study designers can edit different forms at the same time, in Draft mode. However, there are several restrictions and locks that are placed upon areas of a study's design when multiple study designers access it.
• Can I re-use a form's reference code?
  We recommend you do not re-use a form's reference code.
• What if I include a standalone coding question in a form?
  You can include a coding question in any form, but if you don't include read-only items in the same form, having a single coding question won't be effective.
• Can I use a form in more than one visit?
  Yes.
• Do I need to design the layout of a form?
  No. Oracle Clinical One Platform creates the layout for each form based upon the questions and the answer formats that you specify.
• Guidelines for subject tags and code lists in lab forms
  If you ever find yourself stuck with defining subject tags or code lists for your lab forms, these additional guidelines might help you troubleshoot or work around some of the issues you may encounter.
• How many coding questions can I include in a form?
  Typically, you include only one coding question mapped as a verbatim term, indication, or route of administration in a form.
• How strict should my validation rules be?
  When planning your validation rules, consider how strictly you will interpret the study guidelines, and create a validation rule only if you will never accept data outside a certain range.
• I am using a full data collection system for my study. Which forms should I create in Oracle Clinical One Platform, and which forms should I create in my data capture system?
  In this scenario, we recommend creating only the forms required to perform randomization and trial supply management in Oracle Clinical One Platform.
• Should I add validation rules as I create a form or save them for later?
  You might find it more efficient to create validation rules as you create a form; however, you can create all forms and then return to them to add validation rules.
• Understand the options for creating a coding question and coding targets
  Learn more about the options available in the system to define a coding question and its coding targets.
• What answer formats can I use for questions on forms?
  Text, numeric, date/time, and drop-down (for which site users can select multiple answers from drop-down lists).
• What validation rules can I create on questions?
  The validation rules that you can create depend upon the question type, such as Numeric or Text.
• What information should I include in the error message for a validation rule?
  Say what the validation rule is for and what the site user should do. For example: Date of informed consent must be on or after the production date for the study. Please confirm the date.
• When can I mark a form item as read-only?
  You can mark a form item as read-only whenever you want to display a value that is automatically generated by the system. By default, when you create a read-only item you don't allow manual data entry for that item.
• When should I tag a question as required?
  Only when the question is necessary for screening, randomization, or dispensation. For instance, questions that determine whether a subject meets inclusion criteria are typically required. Choose required questions carefully so that you don't inadvertently prevent screening, randomization, and dispensation from occurring.
• Why do I have to define SAS properties?
  SAS variables and labels are displayed in data extracts and play an important role in data analysis. By adding SAS properties to questions in a form, study designers ensure data is easy to review in the SAS v8 format.
• What is the difference between a normal text result and ranges?
  When creating a lab form, you need to remember that the items you include in the form will be used to define lab normals for a local lab. For each lab test, you can either use a normal text result or low and high range values to define lab normals.