Creating a Study

You can create a study to investigate a material.

This task shows you how to:

See Also
Introductory Concepts
Study Data
Phases of a Study
Cloning a Study

Create a Study

You can initially define only the basic information for a study. For example, a description, the name, the type, the purpose, and the objective.

  1. From the Study Design and Tracking home page, click Create a new study.
    For more information, see Create a New Study.
  2. Enter a name for the study.
  3. Optional: Enter the objective and a description of the study.
  4. Optional: Select the type of the study.
  5. Choose the domain standard of the study.

    Note: If you select GMP, you can only select approved activities for the study. For more information, see Defining Tasks.

  6. Click Create.

The Summary tab of the study displays, see Study. Indicates any missing information required to request approval for the study. The new study's identifier is automatically generated with the next available Study Id. For more information, see Reviewing a Study.

Define the Study

You can define the general details of a study, including the date to start the study.

  1. From the Study Design and Tracking home page, click the name of the study for which to add more information.
    This displays the Summary tab of the study. Indicates any missing information required to request approval for the study.
  2. Click to edit the study definition.
    1. Optional: Enter your login information for Foundation Hub, your user must have access to CISPro materials.
    The General Information tab opens and the lists are updated with the available data on the connected Foundation Hub server.
  3. Select the appropriate development phase for the study.
  4. Enter a start time and date for the study.

    Tip: Select the start date using the calendar and edit the generated text for the time.
    This is the time and date when storage of the samples begins.

  5. Select the appropriate study type.
  6. Optional: Click Save.
    The Summary tab of the study is shown again, with any remaining missing information required to request that approval for the study indicated by .
  7. Proceed to select the materials and lots to study.

    For more information, see Specifying Existing Materials and Lots.

When you create a study, this automatically generates a unique identifier. The General Information section of the Summary tab and the header of the study report the study's identifier. For an active (or previously active) study, the identifier is included in the Task Plan details in Foundation Hub.