Annotated Forms and Blank Casebooks

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Annotated forms can be produced in various ways depending on the objective. The following three options are available:

Export a single annotated form with complete data dictionary

Start on the Form Builder page. Select the desired form so that you have it open.

Clicking the Annotate link tells the system to generate a PDF version of the selected form. Once the system has completed generating the PDF version of the CRF, the system will download the Annotated PDF document. The Annotated PDF document shows the layout of the CRF with a field number displayed in red next to each field as shown in the figure below. The field number corresponds to the Field Number displayed on the Form Summary document that accompanies the CRF. 

 

In addition to the form layout page(s) with the field number identifiers, the Annotated CRF also includes a Form Summary page(s) that provides the Form Name, Form Type, Number of Data Fields, and the Total Fields contained on the form. Below the Form Summary is another table that provides additional details for each field as shown in the figure below.

The table provides additional information about each field including the Field Number, Label associated with the field if applicable, Name of the field, Type of field, Length of the field, Choices for the field if applicable, and any Conditional Actions.

 

Annotating All Forms With Complete Data Dictionary

Annotating All forms in one PDF is also an option on the right side of the form builder screen.

To annotate study/site type forms, do not select any versions.

If Conditional actions are not included, a simplified data dictionary will be produced, which leaves out conditional action details.

By default the system will not include child forms built for device/language optimization. If these are needed, check the box to include Child forms.

 

Annotated Forms as a Casebook View

To export all the PDFs in visit order based on how it would look under a study subject, use the casebook view. This leaves out all data dictionary details and exports a single file of only the forms as they would appear on paper.

The PDF file includes embedded bookmarks by Visit for convenient navigation within the PDF.

When exporting the casebook view of the scheduled visits, its important to select which visit schedule cohort is desired.

Unscheduled visits and log forms must be separately exported. They will be exported by sequence and alphabetically.

 

The mobile app can also export blank PDFs - individual forms

 

Tapping the button above will automatically open the PDF preview and also export the PDF instantly to the device's iCloud TrialKit folder (iOS only). No further action is needed. 

If the form content goes off the page due to the parent form design, it's simple to create a targeted child form for the purpose of paper data entry. This way you can have separate layouts for PDF without impacting the validated electronic version.

To create a targeted PDF version of the form, follow these steps:

  1. Create a PDF size option in the device dictionary. If paper width is 8 inches (accounting for .25 inch margins) and there are 100 dots per inch, then any forms targeting this size would screen width setting of 800 pixels wide. Dots per inch x paper width = CRF width.

  2. Open the parent form in the form builder (do not tap save)

  3. Open the form properties

  4. Target the form to the PDF size option. A message will indicate when complete.  

  5. Without tapping the save button on the parent form, open the form library list and select the newly created PDF child version of the form. 

  6. Change the layout as desired for the paper version of the form. 300 DPI is generally a good setting to display all content of most forms.

If some of the content is off the boundaries of the PDF page, adjust the DPI settings in the form properties to a higher value. Normally, a value of 200 is enough to fit most forms on a PDF page.

Save the changes

Tap the PDF export button shown above.

From the IOS app, these are exported to the device’s iCloud folder. If the margins are off the page, the form properties DPI setting can be adjusted.

 

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