To define a dataset for the current Study or Site, perform the following steps:

  1. Select Tasks > Create Dataset.
    The Create Dataset page for the current Study or Site opens.
  2. Click Proceed to Create a Dataset.
    The Create Dataset: Select Items page opens.

    Create Dataset: Select Items

  3. In the Info sidebar panel, click an Event, and then click a CRF for the Event that you want to include in the dataset definition. For the example shown, the Initial Treatment Event was selected, and then the Concomitant Medications CRF for the Event was selected. You can add more Event CRFs in a later step.

    Create Dataset: Select Event

    After clicking an Event CRF, a table displays, listing all of the Event’s CRF Items you can include in the dataset definition. It also lists the metadata for each item, which was defined when the CRF was created.

    Create Dataset: Select Items in Concomitant Medications CRF

  4. In the table, select the checkbox for each Item to include in the dataset definition, or select the Select All Items checkbox. If you are selecting many but not all Items in the CRF, you might find it easier to use Select All Items, then for each item you want to exclude, select its checkbox to clear it.

    Note: With some large studies (> 10,000 Items), the ‘Select All’ function may not work. If this is the case you will have to manually select each Item you want in your dataset.

  5. If you want to add more Event CRFs:
    • Click the Save and Add More Items button.
    • Repeat steps 3 to 5 to select the Event CRF Items to include in the dataset definition.
    • To see the Items already selected, click the View Selected Items link in the Info sidebar panel.

    If you want to select all Items for all CRFs for all Events, instead of selecting each Event and CRF, instead click Select All Items in Study in the Info sidebar panel.

  6. To select non-CRF Attributes to include in the dataset definition, click the link for it in the Info sidebar panel.
    The Create Dataset: Select Attributes page opens for the option you chose.
    For example, when you click Subject Attributes, the Create Dataset: Select Subject Attributes page opens.

    Create Dataset: Select Attributes

  7. Select the checkbox for each Attribute to include.
  8. If you want to include Attributes of a different type:
    • Click Save and Add More Items.
    • Repeat steps 6 to 8 to select additional Attributes to include in the dataset definition.
    • To see the Attributes already selected, click the View Selected Items link in the Info sidebar panel.
  9. After selecting all Items and Attributes you want to include in the dataset, click the Save and Define Scope button.
    The Create Dataset: Define Temporal Scope page opens.

    Create Dataset: Define Scope

  10. Set a date range for the dataset definition by following the onscreen instructions: the date you specify is the Subject enrollment date. For example, if you select 2011 for the year for the Beginning Date and Ending Date, the dataset will include all Subjects who enrolled in 2011. After specifying the date range, click the Continue button.
    The Create Dataset: Specify Dataset Properties page opens.

    Create Dataset: Specify Properties

  11. Provide a Name and Description for the dataset definition, and optionally, change the Item Status. You can also specify ODM ID values, which you might use if you export the dataset to an ODM file format. Then click Continue.
    The Create Dataset: Confirm Dataset Properties page opens.
  12. Verify the Name and Description, then click Confirm and Save.
    The Download Data page opens. Now that the dataset definition exists, at any time you can generate and download a file containing all data that matches the criteria you specified.