Getting started

To access the CRF builder contact Sealed Envelope for details. First you must create your CRF by completing the form requesting the trial name and your email address. Completing this form creates your CRF and sends you the unique URL (web address) to access your CRF in future. You can share this URL with your colleagues but be aware that anyone with the URL can edit the CRF.

Only one person should edit the CRF otherwise changes can be over-written!

Subject details and subject ID

At first your CRF will be empty except for a special Subject details visit. This visit contains the subject registration and withdrawal forms which are used by Red Pill to create subjects and mark them as withdrawn from follow-up.

Subject details visit

Default subject details visit

You can change the wording associated with this visit, and its forms and fields but you cannot delete it or add other fields. You should edit the Subject ID field and check the field size is appropriate for your trial. The subject ID can be automatically generated — add this to your list of customisations if required.

Editing subject ID

Changing the subject ID label and field size

Add the first visit

Add the first visit using the Add a visit link. This will usually be a screening or baseline visit and you will probably want to enter the forms in Red Pill for this visit as soon as the subject is added to the database. To make the forms due immediately, set the Visit is due selection to Subject details form is added. See visits for more information.

Adding a baseline visit

Adding a baseline visit. It will be due as soon as the subject is added to the database.

Add forms

Next add forms to your visit using the Add a form to this visit link. The Label field is displayed in the Red Pill interface and the Name field is used to name the underlying database table. Because of this, names must be alphanumeric, start with a letter, and have a maximum length of 32 characters. The name is used when downloading data from Red Pill.

Adding a baseline form

Adding a form to the baseline visit

The Repeatable option should be selected only if you expect to enter multiple forms for the same subject, such as when recording adverse events or other events that may happen multiple times.

The Subject entered form option indicates that the subject will be expected to complete the form themselves online using Red Pill’s Subject entered forms feature. Talk to Sealed Envelope before selecting this option.

Add sections and fields

To add fields to a form you must first add a section. Sections are used to group fields visually on a form. A section can be repeatable to allow a set of questions to be recorded multiple times. This is useful for recording all concomitant medications on one form for instance.

Add a field using the Add a field link in the section. Choose the best field type to suit the data you want to collect. The Label field is displayed in the Red Pill interface and the Name field is used to name the underlying database column. Because of this, names must be alphanumeric, start with a letter, and have a maximum length of 32 characters. The name is used when downloading data from Red Pill.

Adding a date field

Adding a date field to the demographics form

Viewing a form

Viewing the demographics form

Preview your CRF

Once you have created some visits and forms you may wish to preview the Red Pill application to check on how they will appear when in use. Go to the top level of your CRF and click the Preview link. You can generate a new preview based on your current CRF and then click the blue button to view the preview. You will need to add a subject using the link in the top menu bar first, and then you will see all your visits and forms. You can enter data and test that your forms are acting as you expected.

Preview page

Generating a preview

Preview a form

Previewing the demographics form in Red Pill

Page updated 12 Jan 2018