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.
Parent topic: Randomization FAQs (for study designers)