Verify a study

When you verify a study, you typically check that a user's flow is logical and usable and that the study design matches the protocol. This procedure also applies to rollover studies.

  1. On the Home page, click the pencil button (pencil button) on a study, and make sure a study version is in Testing.
  2. Make sure the correct study version is assigned to active Testing sites and update if required. See Assign a study version to a site.
  3. Click the Testing Mode button (beaker) on the study you want to verify.
  4. Verify the study.

    Consider performing the following verification activities:

    Activity Tips Where to get more information
    Verify data collection:
    • Verify that a user's flow through forms is logical and usable and that you are collecting the data that you expect.
    • Run the Subject Data report to view the data collected for subjects.
    • We recommend randomizing a number of subjects to make sure that randomization and dispensation occur as expected. The number of subjects to randomize depends on your randomization design. For example, if you have a block size of 4, you might want to randomize 8 or more subjects.
    • We recommend completing all forms in the study for at least one test subject to make sure that the study design meets your expectations. Consider checking that:
      • The Site drop-down in the upper-right corner contains all sites that you expect to see.
      • Required questions are identified correctly.
      • The text in the Question Hint panel on the right is useful.
      • The validation rules work as you expect.
      • You are capturing data as you expected.
      • The forms flow as expected.
      • Site users will have a positive experience entering data.

    For information about a site user's activities, see the Site User Guide.

    See how to Run a report and Subject Data report description.

    Verify the workflow of kits.

    None. See Manage kits at the site and study level.

    Verify that randomization and dispensation occur in accordance with the specifications.

    Consider verifying the following information:

    • The correct randomization numbers are assigned to subjects.
    • Subjects are dispensed kits in accordance with the dispensation schedule.
    • If the study uses label groups, kits have appropriate labels for countries.
    An unblinded user can View a subject's randomization number in a study you are verifying in Testing mode and can also run the following reports:
Once you have verified your study is in compliance with the study protocol, you are ready to go live. To do this, configure your study settings in Production mode as you did for Testing mode.