When I create a randomization design, what fields should I choose?

The fields you choose depend on whether the study is open-label, blinded, or both open-label and blinded.

First (or only) period of the study is open-label

Subjects must be randomized when the study starts with an open-label period.

• Type: Choose Unblinded.
• Randomization: Choose any algorithm. Do not choose None - Open Label; a study that starts with an open-label period must randomize subjects.
• Re-Randomization: Choose No.

First (or only) period of the study is blinded

With this randomization design, subjects are randomized, and the study remains blinded.

• Type: Choose Blinded.
• Randomization: Choose any algorithm.

  If you choose a stratified option: In your second randomization design, you must choose Randomized. You won't be able to assign a randomization design to a visit if you choose Mapped.

• Re-Randomization: Choose No.

Second or later period of the study (if required) is an open-label extension

What do you want to happen when you start the open-label extension?

• Keep all subjects on their current treatment arms while revealing the treatment description:
  • Type: Choose Unblinded.
  • Randomization: Choose Open Label - None.
  • Re-Randomization: Choose Yes.
• Move subjects to new treatment arms, or keep subjects in their treatment arms (or do a combination of the two options). When subjects in 1 treatment arm are moved to multiple treatment arms, randomization determines their new treatment arms:
  • Type: Choose Unblinded.
  • Randomization: Choose an algorithm without "stratified" in its name for subjects who will be randomized. You can't map subjects to treatment arms if you choose a stratified algorithm.
  • Re-Randomization: Choose Yes.
  • Treatment Arms: Choose Mapped.

    Tip:

    You'll specify how subjects change treatment arms when you assign the randomization design to a visit.

Second or later period of the study (if required) is blinded

Do I need to create a second randomization design? Only if you need to start a blinded period with randomization.

What do you want to happen when the blinded period begins?

• Randomize all subjects (either again or for the first time):
  • Type: Choose Blinded.
  • Randomization: Choose any algorithm.
  • Re-Randomization: Choose Yes.
  • Treatment Arms: (Appears only if you choose a non-stratified algorithm; for stratified algorithms, the only option is to randomize all subjects again) Choose Randomized.
• Move subjects to new treatment arms, or keep subjects in their treatment arms (or do a combination of the two options). When subjects in 1 treatment arm are moved to multiple treatment arms, randomization determines their new treatment arms.
  • Type: Choose Blinded.
  • Randomization: Choose a non-stratified algorithm for randomizing the subjects who will be randomized. You can't map subjects to treatment arms if you choose a stratified algorithm.
  • Re-Randomization: Choose Yes.
  • Treatment Arms: Choose Mapped.

    Tip:

    You'll specify how subjects change treatment arms when you assign the randomization design to a visit.

Small study with smaller cohorts

Subjects must be randomized in a balanced manner across stratum groups.

• Type: Choose Unblinded or Blinded, based on your study period.
• Randomization: Choose Minimization.