This section will demonstrate how you can build Castor study structure from a paper case report form.
This example CRF page captures Demographics data:
The Structure tab allows you to outline the different forms, i.e. sections that contain related data.
Study forms: Phases/steps
Phases in Castor normally represent study visits. In the example below, one phase ‘Baseline Visit’ is created. A step is a form within this phase (visit) that groups one or more related questions (fields). In our example, the baseline visit contains groups of questions related to ‘Demographics’, ‘Informed consent’, ‘Inclusion criteria’ and ‘Exclusion criteria’. The relevant steps are thus created in the Baseline visit phase:
Reports: Repeated Measures
Looking at the CRF example in the beginning of this article, we see a tabular representation of Medical history. This section contains information about all relevant medical conditions of a subject. One patient can have several relevant medical conditions and another patient can have none. Such instances that can occur 0-N times for each participant require a Report form in Castor. With such repetitive instances, it is often convenient to choose the Repeated Measure type of report, as this can be displayed in a tabular format (see below).
Below you will see how the Medical history repeated measure looks like in the eCRF for one participant. Using the ‘Add measurement’ button, any number of conditions can be added. In the example below, a patient has only one medical condition:
This patient has more than one medical condition:
Other common examples where a Repeated measure Report form can be used to collect data are Blood pressure and Concomitant medications.
Reports: Serious Adverse Events and other events
Report forms should also be used in case any unintended events occur which are not part of the main study data capture. The reason for this follows the same 0-N principle as repeated measures - it is unknown how many times these events will occur for a patient, and therefore it is best to use a report form instead of a study form. The advantage of a Reports form is that once the structure is created, a report form can be generated any number of times and can be linked to any phase of a study. The Report form structure, type 'Event' in Castor:
Reports, similarly to study phases, also consist of steps.
In the example below one Serious Adverse Event report form is created and linked to the Baseline Phase:
Surveys and Survey packages
Surveys and survey packages are used when study participants are the ones entering data, for example, via a link sent electronically.
The survey structure also consists of steps, which represent the different survey pages:
You can add questions (fields) to the survey structure via the Form tab.
In order to send the surveys electronically to your study participants, you will also need to create a survey package:
You can imagine survey packages as the envelopes or ‘packages’ in which you put the surveys. You can then send this survey package to a patient via email. This email contains a link to the survey package, where the participant can immediately fill in data.