Summary

This article covers custom PDF forms. 

Table of Contents

The application allows for custom PDF forms to be generated based on data currently entered into the system. The best example are Serious Adverse Event forms that must be printed and sent to a monitoring and/or regulatory agency.

The site can select the custom PDF form and have many of the fields be auto-populated from what they entered on the eCRF. This reduces duplication of work and the potential for transcription errors on the paper form.

Configuring the PDF

PDF Form Auto-Population requires a base PDF file to be uploaded to the system as a data file. This guide will use an old MedWatch FDA reporting form as an example, however any PDF file can be used in practice. You will need Adobe Acrobat Professional to create the form, Acrobat Reader does not have the necessary features.



In order to tell the eClinical system where to populate the data, a form must be created on the PDF. Each form field will correspond to a question path or formula within the eClinical application.

Text Fields

Text fields in the PDF form can be used for any question type in the eClinical application, however they are most used for Text, Date, and PartialDate data types. To create a text field, in the Acrobat Professional menu select Tools > Forms > Text Field Tool. Then drag a box over the area where you would like the data to be populated.



After the text field has been created, change the “Name” of the text field to be the path of the question in the eClinical application. In the example of Date of Birth, a valid path might be “#visitScreening.demographics.dateOfBirth”. After entering the name, close the “Close” button. The text field will update to reflect the new name.


Questions on Dynamic Forms

If your PDF is created from a dynamic form in eClinical, such as an Adverse Event, many of the fields you wish to auto-populate will come directly from that eCRF. In that case, the name of the PDF form field should be only the questionId, not the entire path.

Checkboxes

Many PDFs have checkbox questions. In this case, each separate checkbox will be a field on the PDF. To support this, you must use the Formulas worksheet in the DataArchitect file. Each individual checkbox will need a corresponding formula. When that formula evaluates to “true”, the checkbox will be marked. The Data Type of these expressions should always be “Boolean”, and the Expression Type should always be “expression”.

For example, a gender question would require two formulas, one for Male and one for Female. An appropriate formula for female would be #visitScreening.demographics.gender == ‘female’. If the formula is true (i.e. “female” is checked on the eCRF), the PDF will check that question.


After the formulas have been created, you will need to add Checkbox form fields to the PDF file. In the menu, select Tools > Forms > Checkbox Tool. Then drag a box over the checkbox on the form. The name should be that of the formula created for this checkbox.


Field Properties

Appearance

Each field on the PDF can be customized for size, font size, font type, and other display options. Double-click on a form field and select the “Appearance” tab. The default font size is “Auto” which will adjust to fit the contents into the box provided. You may wish to keep this or hard code an exact size for every field. The default font type is Helvetica, again you may keep this or change to suit your needs. Note that more exotic fonts may not be supported by eClinical. You can also change the text color, border color (if any), and even fill color.


Options

The “Options” tab allows you to change the right-left alignment of the text, allow multi-line text, a character limit, or to comb the text. Setting a comb is useful for questions like subject number or initials, where on the form there are distinct boxes in which to place each letter. Creating a text field covering every box and then setting the comb to the appropriate number of characters will allow for the PDF auto-population to correctly fill in that field.


Configuring the DataArchitect

App Properties

The App Properties tab contains the specifications for which eCRFs have auto-populated PDFs available, and which PDFs to use for those eCRFs. There are three properties to configure for every auto-populated PDF:

  • formnamePDF#
  • formnamePDF#Name
  • formnamePDF#Default

The “formname” is the formTypeId of the form on which the PDF should be available. Set “formnamePDF#” to be the name of the PDF file that will be uploaded to eClinical. This will also be the name of the filename when users download it from the eCRF. The “formnamePDF#Name” property defines what appears in the drop-down PDF menu on the eCRF. In most cases, “formnamePDF#Default” can be set to “true”.


Roles

You must determine which roles will be able to access the auto-populated PDF. To do this, create a new row on the Roles Worksheet. The “Actions” column should be a plain english description, such as “Serious AE PDF”. Leave “Actions Required” blank, but enter “Screens Required” with the name of the PDF property configured on the App Properties worksheet. For example, if you have the property “saePDF1″ with value “seriousAE”, you would enter “seriousAE” on the App Properties worksheet. Place an “X” in the column for each role that should have access to the PDF.

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