Details for sponsors

Which studies can now be built in Oracle Clinical One Platform?

• Open-label studies

  An open-label study must have one or more randomization events.

• Blinded studies

  A blinded study can now have one or more randomization events.

• Blinded and open-label studies

  Studies with both blinded and open-label periods can have one or more randomization events, and can:

  • Start blinded, and then have an open-label extension.
  • Start open label, and then become blinded.

    To start as open label, a study must randomize subjects when the open-label period begins.

What options are available for subjects changing treatment arms during the second randomization event?

You have the following options for both open-label and blinded periods:

• Randomize all subjects again.
• One of the following:
  • Move all subjects to new treatment arms.
  • Keep all subjects in their treatment arms.
  • Move some subjects to new treatment arms, and keep other subjects in their treatment arms.

  When subjects in 1 treatment arm are split into 2 or more treatment arms, randomization determines their new treatment arms. For example, consider a study with 3 treatment arms: 5 mg dose, 10 mg dose, and placebo. Subjects in the 5 mg dose and 10 mg dose arms remain in their treatment arms throughout the study, and subjects in the placebo arm are randomized to determine whether they move into either the 5 mg dose or 10 mg dose arms.

  More variations are possible. For instance, the study can add or drop treatment arms, and subjects can be mapped or randomized into an added treatment arm.

Tip:

If you're doing a crossover study where all subjects swap treatment arms without being re-randomized, you don't need to create a second randomization design. Instead, you can simply update the dispensation schedule so that subjects receive the appropriate treatment for each visit. This functionality was available before this system update.

In an open-label period or study, what unblinding information is visible, and where is it?

The Kit Reconciliation tab, which provides unblinded users with the same view that site users have, has a new Kit Description column, which lists Blinded for any kits with blinded descriptions. Unblinded users will continue seeing the kit type description on the Inventory tab; this functionality isn't changed.

For details about what site users and blinded users at your organization see, see Details for sites and sponsor users who view subject data.

Any reporting changes?

Yes! For details, see Report improvements.

Any other changes?

The code view pop-up was modified to provide details about each randomization event in the study. The pop-up provides the same details as before, including the treatment arm title and kit description, but the new organization of information makes it easier to find what you're looking for.