Designing Response-Dependent Branching

You can design a CRF so that the response to a particular Question for a particular patient changes which additional Questions should be entered for that patient.

There are three different types of branching available:

• Indicator branching: If a patient's response to a Question should determine whether the remaining Questions in the same group should be collected for that patient, use indicator branching, which you define in the Global Library at the Question Group level. You define the first Question in the Question Group as an indicator Question and specify the response value that makes the remaining Questions in the Question Group collectible. If a value other than the indicator value is entered for a patient, the cursor moves next to the first Question of the next Question Group.

  For example, define the first Question, SEX, to collect the patient's gender, with only two allowable values: MALE and FEMALE. If a patient's response to SEX is FEMALE, then the remainder of the Questions in the Question Group, which cover pregnancy and menopause, become collectible for the patient. If the patient is male, these Questions are not collectible for the patient. The next Questions available in data entry are in the next Question Group in the DCM, if any.

• Conditional branching: If the initial, or source, Question should make Questions in the same or a different Question Group in the same DCM collectible, use conditional branching, which you can define in either the Global Library or in a study at the DCM Question Group Question level. You must specify a target Question for each allowable response. The logic can include a range of responses, defined as greater than, less than, or equal to a particular value.

  For example, define a Question "Are you pregnant?" with a DVG containing three values: Yes, No, and I Don't Know. For the response Yes, define a target of the first Question in a Question Group about the pregnancy. For I Don't Know, define a Question "Is lab test scheduled?" as the target, with the Question "Date scheduled" nested. For No, either define a target of "Verification that lab test confirms" or do not define a target at all, in which case the cursor goes to the next sequential Question during data entry.

• Branching to make Questions, visits, or Intervals expected or not expected for a patient: If the initial, or source, Question should make Questions collectible that are included in a different DCM, or even a different CPE (Clinical Planned Event, or Visit) or Interval, use Enhanced DCI Books and their rules to define these relationships; see Designing a Flexible Study and Flexible Study Design Examples.

  Note:

  This type of branching is different from indicator and conditional branching in that the Questions made collectible by the response value may or may not be the next Questions answered in data entry—they may be in another CRF or visit entirely.

  For example, define a Question Age. If the study has an age limit of 60 and the patient is 60 or under, the normal series of visits becomes expected for the patient (up to the next source Question, if any). If the patient is over 60, only the End of Study visit is enabled.