Phases of a Study

This topic describes the phases involved in the creation, definition, activation, and completion of a study involving multiple Study Design and Tracking users. When you create a study, its initial lifecycle state is Unapproved. The goal of a study is to gather data and ultimately transition the study to the Finalized state. A defined group of users (members of the study) typically performs the transitions in the workflow, depending on their access role, review rights, and whether they have made any edits.

This page discusses:

See Also
About the Lifecycle of a Study
Study Design and Tracking Access to Content

Lifecycle Maturity

The general progression through the lifecycle of a study is:

  1. Create.
  2. Define.
  3. Request approval.
  4. Approve.
  5. Activate.
  6. Complete.
  7. Finalize.

Other transitions are:

  • 8. Reject.
  • 9. Pause.
  • 10. Reactivate

Each transition through the workflow is controlled. Only appropriate study members can begin each transition and they must formally provide an electronic signature for their action.

1. Creating a Study

When you create and save a study for the first time, you specify some basic information and the study saves in the Approved state. The user who creates a study is automatically an Owner.

2. Defining a Study

When you define a study to add materials, storage conditions, time points, and activities, the study saves in the Approved state. When it is fully defined, you can request approval.

3. Requesting Approval

A study must fulfill certain criteria before you can request approval.

  • A user creates a study, adding members and assigning them access roles and review rights.
  • The members with Collaborator or Owner access roles fully define the study.
  • An Owner study member requests approval, selecting one or more study members with review rights who have not edited the study.

    If all members have edited the study, you must add another member with review rights, before you can request approval. For more information, see Defining Study Members.

When you request approval, the study moves to the Pending Approval state. For more information, see Requesting Study Approval.

Another user can approve or reject a study that is Pending Approval.

4. Approving a Study

Only a specified study member with review rights who has not edited the study can approve.

An appropriate user reviews a Pending Approval study, before they approve or reject it. For more information, see Reviewing a Study.

When you approve a study that includes requests to manufacture material lots, the approval applies to the manufacture as well as the test tasks.

When you approve a study, it moves to the Approved state. For more information, see Approving a Study.

You can reject or activate an Approved study. For more information, see Withdrawing a Study and Activating a Study.

5. Activating a Study

Only an Owner study member can activate it.

When you activate (launch) a study, it moves to the Active state. This creates the Foundation Hub Task Plan, Tasks, and Samples. The study's name populates the Task Plan's name and the Task Plan details include the study's identifier. For more information, see Activating a Study.

If you reactivate a previously activated study, this updates the corresponding Foundation Hub Tasks, as appropriate for the changes to the study:

  • Abandons draft, assigned, or submitted Tasks corresponding to removed tests and deletes their Samples.

    Tasks abandoned in this way are not represented in the Monitoring tab of the study.

  • Returns the suspended Tasks to their former state before pausing the study.
  • Updates start dates for Tasks.
  • Creates Tasks and Samples for new tests.

You cannot remove tests from a study if they correspond to in progress, complete, or released Tasks. To abandon these Tasks, use Foundation Hub to change their status. Tasks abandoned in this way remain represented in the Monitoring tab of the study. For more information, see Reactivate the Edited Study.

You can reject or pause an Active study.

6. Completing a Study

Only an Owner study member can indicate that it is complete.

When you complete a study, it moves to the Complete state. For more information, see Completing a Study.

You can finalize or reactivate a Complete study.

7. Finalizing a Study

Only a specified study member with review rights who has not edited the study can finalize it.

When you finalize a study, it moves to the Finalized state. For more information, see Finalizing a Study.

You can return a Finalized study to the Active state.

8. Rejecting a Study

The access roles and rights required for a study member to reject it depend on the state from which it is rejected:

  • Pending Approval - the Owner who requested approval or a study member with Review Rights can reject it.
  • Approved - an Owner can reject it.
  • Inactive - an Owner can reject it.
  • Active - an Owner can reject it.

When you reject a study, it moves to the Unapproved state. For more information, see Withdrawing a Study.

You can edit an Unapproved study and then request approval again.

9. Pausing a Study

Only an Owner study member can pause it.

When you pause (inactivate) an active study, it moves to the Inactive state. This suspends the Foundation Hub Tasks that are in draft, assigned, or submitted states. You can still change the status of in progress Foundation Hub Tasks for an Inactive or Unapproved study. For more information, see Updating an Active Study and Reactivating an Inactive Study.

You can reject an inactive study. You can then make edits, and restart the approval process. For more information, see Reopen the Paused Study.

10. Reactivating a Study

Only an Owner study member can reactivate it.

When you reactivate (launch) an inactive study, it returns to the Active state. This updates the Foundation Hub Task Plan, Tasks, and Samples. See Reactivating an Inactive Study.

You can reject or pause an Active study.