Updating an Active Study

You can make changes to a study that is already active. Several steps transition the study through lifecycle states so that you can ensure tracking of audit events and so that you can choose to reactivate without edits if appropriate.

This task shows you how to:

See Also
Working with Study Lifecycles
About the Lifecycle of a Study
Monitoring a Study

Context:

If you identify that a study requires modification, you can pause it to immediately halt any Foundation Hub Tasks and move it to the Inactive state. To modify the study, you can reject it to return it to the Unapproved state. You can then edit the study and request approval of the changes, before re-activation.

Important: You cannot change the master sample setting for a study after its initial activation.

Pause the Study

You can pause a study that requires edits.

  1. From the Home Page, open the study to pause.

    For information, see Opening a Study.

  2. Click Pause.

    Tip: You can also reject an active study.

    The form to request pausing the study opens. For more information, see Study Signature Form.
  3. Choose the reason for signing the study and add a comment.
  4. Enter your password to confirm that you are formally providing your electronic signature.
  5. Click Sign.

The Summary tab for the study is shown. The Lifecycle and Status tab shows that the study is now in the Inactive state.

You can directly reactivate the inactive study if you do not require edits. For more information, see Reactivating an Inactive Study.

Reopen the Paused Study

You can reject an inactive study that requires edits.

  1. From the Home Page home page, open the inactive study to reopen.

    For more information, see Opening a Study.

  2. Click Reject.
    The form to request rejection of the study opens. For more information, see Study Signature Form.
  3. Choose the reason for signing the study and add a comment.
  4. Enter your password to confirm that you are formally providing your electronic signature.
  5. Click Sign.

The Summary tab for the study is shown. The Lifecycle and Status tab shows that the study is now in the Unapproved state.

You can edit the study and restart a request for approval. For more information, see Requesting Study Approval and Approving a Study.

When editing a paused study, you cannot make the following changes:

  • Change the selected materials and change their order. For more information, see Specifying Materials and Lots.
  • Edit the input parameters for lot manufacture requests.
  • Alter the Master Sample setting.
  • Alter the Sample Reuse setting.
  • Remove or edit storage conditions.
  • Clear boxes in the Test Design for which at least one task is already in progress.

If you edit the test design for the study such that it requires more material than is available or requested, the Materials tab and Summary tab display warnings.

For a study with sample grouping, if you edit the test design after activation, this updates the groups of samples so that the Tasks in the Foundation Hub Task Plan are consistent with the test design. If you add a new activity, time point, or storage condition, this adds the appropriate samples to existing Tasks or creates a new Task if required. If you remove an activity, time point, or storage condition, this removes the Samples from existing Tasks and abandons the Task if it has no Samples.

Reactivate the Edited Study

You can reactivate a paused study when another study member approves the changes.

Follow the instructions in Activating a Study.

The Summary tab for the study is shown. The Lifecycle and Status tab shows that the study is now in the Active state.

This updates any existing suspended Foundation Hub Tasks, according to the changes made to the study.

For more information, see Phases of a Study.