This article describes a method for downloading single Participant Casebooks and Archival Casebooks within Study Runner. 

Download Single Participant Casebooks

You can access a Participant Casebook from the Participant Details screen.

A Participant Casebook includes participant data, excluding data that you do not have permission to view.

  1. Click the Participant Matrix header button in Study Runner.
  2. Click the Participant ID or the View button next to the participant you want to download data for.

Note: 

You can also skip steps 1 and 2 and go directly to the Participant Details screen by entering the Participant ID in the Search box in the upper-right hand corner of any screen within the Study Runner.

  1. Scroll to the bottom of the Participant Details screen, and select Casebook.    
  2. Under Format, click the radio button next to JSON, CDISC ODM XML, or PDF to choose the format in which you want the data downloaded.
  3. For JSON and CDISC ODM XML formats, uncheck the checkboxes if you do not want to include certain options in the data. You can choose to include or exclude: Notes & Discrepancies (Queries, Annotations, and Reason for Change), Audit Trail, Metadata, and/or Archived Form data. Note: The selections cannot be changed for PDF format.

Note: Casebooks always include Clinical Data.

  1. Choose how to view the data (if applicable):
    • For XML or JSON files:
      • To get a link, select the Get Link button. Highlight and copy the link into the URL bar in your browser to view the data.
      • To open the webpage directly in your browser, select the Open button.
      • To download the file, select the Download button.
    • For PDFs, click Get PDF to initiate the process. 
  2. A green message bar will appear letting you know that the PDF is being generated. This may take some time if it is a large study. Click the Bulk Actions Log link or click Tasks in the header bar of Study Runner and select Bulk Actions Log to navigate to the Bulk Actions Log and view the status of the job. Refresh the page if the job has not completed yet.
  3. Click the Download icon to download the Participant Casebook that was generated.

Download Archival Casebooks

Data Managers also have the option to download the all participant casebooks at once for archival purposes. This can be done for the entire study or for a single site.

  1. From the Tasks menu in Study Runner, select Archival Casebooks.
  2. The Archival Casebooks page opens. 
  3. Check the checkboxes if you want to include or exclude Removed Participants and/or forms hidden at sites. They are unchecked by default.
  4. Click the Get File button to generate the Archival Casebook.
  5. A popup message will appear warning you that generating a PDF casebook for every participant in the study could take a long time. Clicking the Yes button will generate the Archival Casebook. 
  6. The Get File button will be disabled until the job has been completed or canceled.
  7. A green message bar will appear letting you know that the PDF is being generated. This will take some time if it is a large study (likely hours or days). Click the Bulk Actions Log link or click Tasks in the header bar of Study Runner and select Bulk Actions Log to navigate to the Bulk Actions Log and view the status of the job. Refresh the page if the job has not completed yet.
  8. If you need to cancel the Archival Casebook job while the job is still in progress, click the Cancel icon. Any participant casebooks generated prior to canceling will be available for download, as well as the summary file(s). 
  9. Click the Download icon to download the Annotated Casebook PDF ZIP archive that was generated.
  10. The Archival Casebook download contains the following in a ZIP archive:
    • A CSV summary that includes the number of participant casebooks that succeeded and failed, creation date, whether the zip file includes removed participants, and a list of those participants included in the Archival Casebook zip file.
    • A CSV summary file for each site with the number of participant casebooks that succeeded and failed, creation date, whether the zip file includes removed participants, and a list of those participants included in the site Archival Casebook folder.
    • A PDF file for each participant that includes:
      • A cover page with the Participant OID, Study Name and Study OID, Site Name and Site OID (if the participant is assigned to a site), and Participant Status.
      • A Table of Contents that includes the Participant OID, a heading for each event, and a page number for each CRF below the associated event.
      • A title sheet for each participant PDF that includes Participant ID and Participant OID, Study Name and Study OID, Site Name and Site OID (if the participant is assigned to a site), Event Name  and Event OID, Event Repeat Key, Event Start and End Dates, Event Status, Event Lock Status, Event Signature Status, Form Name and Form OID, Form Status, Form SDV Status, Form Query Status, and Form Version.
      • The contents of the CRF.

Notes:

Participant casebooks contain all forms the user generating the casebook has access to. If the user does not have permissions to view a particular form, it will not be included in the casebook. Contact data forms will only be visible for users who have access to them, but contact data values will be masked for extra security.

Participants who do not have any forms will be included in the zip file, but the PDF will indicate that the participant does not have any forms or the user generating the PDF does not have permission to view any of the participant’s forms.

Languages

Casebooks can be displayed in different languages (only for studies configured to support this). When a form has multiple languages configured, the Casebook will display in the same language that would appear for the user when opening a form to edit on screen.

This only applies to the labels and hints defined for the form.

Note: OpenClinica does not yet have every language configured and tested. New languages are added to the system by request. If your preferred language is not currently set up in OpenClinica, please reach out to our Support Team to discuss getting it added.