Conversion of a paper CRF

You can use the CRF Builder to create an electronic version in Red Pill of your paper CRF. Below are some tips to help you with this process.

Likert section

When you have a set of questions that are answered using the same categories, it is useful to format them as a Likert section. All fields within a Likert section must be category fields with the same categories. Red Pill displays Likert sections as a grid of radio buttons. Each field shows as a row in the grid.

Paper CRF category fields with same categories

Choosing Likert section format

Likert section in Red Pill

In this case, the Likert section is more convenient for data entry than the category fields.

Category field format in Red Pill

If you choose the Likert scale section format but the categories are not the same for all fields, you will not be able to build your trial until the error has been corrected.

Trial cannot be built until categories are the same for all fields in a Likert section

Inclusion/exclusion criteria

You can format your eligibility questions (answered as Yes/No on the paper CRF) using the specific inclusion/exclusion criterion field types. When the field type is inclusion criterion, the answer must be Yes when entering data on Red Pill; on the other hand, for exclusion criterion, the answer must be No. The user will otherwise see a validation error message.

Inclusion criteria on paper CRF

Validation error message in Red Pill when inclusion criterion is answered as No

Be aware that if your eligibility questions are located on the randomisation form, the inclusion/exclusion fields will need to be answered correctly in order to randomise a participant (i.e. validations cannot be overridden); therefore, you will not be able to record non-eligible participants. If you would like to record non-eligible participants, it is advisable that you include your eligibility questions formatted as Yes/No fields on a form that is not the randomisation form.

Common rules

Conditional free-text fields

When you have a free-text field to be completed depending on a previous question, you can use 'skip unless/required if' rules as exemplified below. The free text field will only be shown when the previous question is answered as Yes.

Conditional free-text field on paper CRF

Conditional free-text field in CF builder

Date fields

Consider adding rules to date fields for the following cases:

• Start and end dates: add a rule that the end date must be on or after the start date.
• Sequential visit dates (e.g. Day, Day, 2, Day 3...): add a rule that the date must be 1, 2, 3... days after Day 1, respectively.
• Dates of investigations/tests that must be the same as or before/after a certain date of reference: add a rule to check this.

Please see Field rules for more details.

Repeating forms and sections

Adverse/serious adverse event forms

It is advised that you format these as repeating forms. 

SAE table on paper CRF

SAE as a repeating form

Concomitant medications

It is advised that you format these as repeating sections. You can add a leading question to determine whether any repeating sections are expected (if you haven't included one on your paper CRF) and request a custom validation rule to enforce completion.

Concomitant medications table on paper CRF

Concomitant medications as a repeating section in the CRF builder

Concomitant medications as a repeating section in Red Pill