OpenClinica allows the user to select specific Events, Forms, and/or items (or all data) to be included in a dataset. The dataset can then be exported on demand or on a regular schedule.

You can create a dataset with any data that has been entered into OpenClinica. You can also combine data from different Events and Forms as needed when creating a dataset.

Once you define the data that you want to extract, you can choose from a number of different formats in which to view and work with that data. Once the extract is run, datasets include data from all sites and all participants within those sites.

You can also download Participant Casebooks to extract all data on a single participant.

Archived and removed Forms are not included in any extracts by default (although archived Form Versions are included.) This setting can be changed for Participant Casebooks or when using the API.

To Create a Dataset:

  1. Click Tasks in the header bar, and select Create Dataset.

  1. In the left panel, expand the Event that contains the Form data that you want to extract. If the Form is in multiple Events, select one Event now, and add more Events and Forms later.

  1. Select the Form that contains the data you want to extract.

  1. Select individual items, or to select all items in that Form, check the Select All Items checkbox above the item list.
  2. (Optional) To select additional items, either from the same Form in other Events, or from a different Form, click Save and Add More Items. Then repeat steps 2 through 4 until you have selected all of the items you want to include in the dataset.

Note: In addition to selecting data from Forms, you can also select data from Events, Participants, and CRFs from the Event/Participant/CRF Attributes screens. You can also click Select All Items in the Study to include all items in the study.

  1. Once you have selected all of the items you want to include in the dataset, click Save and Define Scope. The Name and Description screen appears.

  1. Enter a name and description for the dataset.

Note: Names must be alphanumeric characters, but underscores are permitted.

  1. In the Item Status field, select the completion status of the data you want to include in the extract. You can choose to include data from: CRFs marked Complete, CRFs not marked Complete, and all CRFs.
  2. Ignore the message and fields on the lower portion of the screen, and click Confirm and Save.