Changes to the Study Design report

For the new Age question type

Any Age questions that you create appear in their own rows in the Forms section. The Answer Type for Age questions is Calculation.

For the open-label and multiple randomization designs change

• The Study Design Summary section has a new Blinded Status column. This status is set in the randomization design that was applied to the visit or a prior visit.

  N/A appears for unscheduled visits, including screening, withdrawal, and study completion visits.

• The Randomizations section has a new Blinded column, which indicates whether a randomization design is blinded or unblinded.
• When a study has multiple randomization designs, the Randomizations section now has columns for the new settings for a randomization design, including:
  • Blinded Status
  • Re-Randomization
  • Treatment Arms Randomized or Mapped
  • Assign New Randomization Numbers to All Subjects
• The Treatment Arms section now shows columns for New Treatment Arms and Previous Treatment Arms, so you can easily track how subjects are mapped to new treatment arms in a randomization design.

  Previous Treatment Arms has a value only when the randomization design is a re-randomization in which subjects are mapped to treatment arms. Otherwise, N/A appears. New Treatment Arms always has a value for every type of randomization design.

For calculated doses on kit types

• In the Kits section, a new Calculating Doses column lists either Yes or No for each kit type.
• When Calculating Doses is Yes, a new Calculated Doses section appears within the Kits section and includes all the details specified in the calculated dose, including the title, the kit measurement, and the dosing frequency.

For the new subject numbering fields

The values of the new subject number settings now appear in the Subject Settings section.