Stability Study Workflow

Study Design and Tracking works in collaboration with several other applications. The users working with this app and with other tools in the workflow might or might not be the same users of these applications.

1. Create a study, providing a name and other required information.

   Typically, study managers create stability studies. They own the study and are responsible for planning the work performed by the scientists.

   For more information, see Creating a Study and Cloning a Study.

2. Design the study.

   Typically, a study Owner designs the stability study, by collaborating with the scientists, project managers, and analysts to determine the requirements.

   1. Add the members to the study and assign their permissions (Owner, Collaborator, or Reader).

      For more information, see Defining Study Members.

   2. Specify the materials to investigate in the study.

      For more information, see Specifying Materials and Lots.

   3. Define the storage conditions and choose the activities to perform during the study.

      For more information, see Defining Storage Conditions and Defining Activities.

   4. Define the time points at which to study the materials, and choose the tasks to carry out at each time point.

      For more information, see Designing Tests and Defining Tasks.

   5. Specify the sample management options.

      For more information, see Configuring Samples.

   Note: If the study requires new activities, a scientist can define them in Foundation Hub or a recipe author can create them in BIOVIA Compose.
3. Review the design and request approval of the study.

   Any Owner can request approval.

   For more information, see Reviewing a Study and Requesting Study Approval.

4. Approve or reject the design.

   A specified study member with review rights, who has never edited the study, can approve or reject the design.

   For more information, see Approving a Study.

5. Activate the study.

   Any owner can activate the study. This generates a Foundation Hub Task Plan with the specified Tasks and the Samples required to fulfill the study design.

   For more information, see Activating a Study.

6. Perform the required tasks at the defined time points and storage conditions on the material samples.

   One or more scientists perform the tasks and track their work in Foundation Hub. Scientists can record their results in BIOVIA Capture or in the Task Plan. If the start dates require changes, scientists can update the affected Samples and Tasks, using either a Foundation Hub Task Plan action or a Pipeline Pilot Web Port job.

   If the study includes requests to manufacture new materials or lots, the scientist can receive the manufactured Samples in CISPro.

7. Monitor the tasks and review the results of the study.

   An Owner, Collaborator, or Reader can monitor the progress of the tasks and review reports containing status and results. They can generate reports either on the Monitoring tab of a study, as actions on the Samples tab of a Foundation Hub Task Plan, or in the Pipeline Pilot Web Port.

   For more information, see Monitoring a Study and Generating Reports for a Study.

8. When all results are recorded and all Foundation Hub Tasks are released, complete the study.

   Any Owner can determine when a study is complete.

   For more information, see Completing a Study.

9. Review the results and finalize the study when the study's requirements are met.

   A specified study member with review rights, who has never edited the study, can finalize the study.