Visits in Red Pill organise forms in the CRF into logical groupings. Mostly, the visits will correspond to real-world visits the participant makes, such as baseline and follow-up visits. They can also be used to group forms that are completed on demand (such as adverse events and other clinical events), and to sub-divide stages of a long real-world visit (such as in-hospital).
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Visits can be scheduled by defining time-points when they become due. When visits are scheduled, they show up on the Red Pill Overdue forms page, and due dates and overdue forms are shown in the participant details highlighted in red.
The time-point when a visit is due is set in the visit details. Due dates are calculated relative to another date, such as the date a form was completed, or a date field in a form. The Visit is due dropdown allows any date in the CRF to be selected. It also includes the date when forms are added to Red Pill. For example, a baseline visit could become due 0 days after the subject details form is added. This would mean as soon as the participant is added to the database, all baseline forms would become due.
The offset field allows visits to become due a defined period after the visit date. For example, a 3-month follow-up visit might be set to become due 3 months after the randomisation form is added (i.e. date of randomisation). Or an in-hospital form might become due 3 days after the date of surgery.
Even if you're not sure exactly when a visit will become due (e.g. a discharge visit), it is worth setting an offset to highlight visits that are outstanding after the visit would normally be expected to have taken place.
It is also possible to use arbitrary text to define when the visit is due. For example, for visits that don't have a specific due date (such as the first visit when a participant is recruited), you can apply a text description instead, such as ‘At any time’, or you might describe an optional visit as due only if certain criteria are met. These text labels will be displayed in Red Pill, but due dates will not be calculated, and the visit will not appear on the Overdue forms page.
Within each visit, you can optionally define a visit date. This visit date can be either a date field collected on a form in the visit or the date when a form in the visit is added; this means that the visit date cannot be set until you have created at least one form in the visit. It’s recommended that you set this field as required.
If you set a visit date, it will be used on the Red Pill 'Visit summary' report. This report shows, by site, how many participants have completed this field, the range of dates entered, and an estimate of the number of participants per month completing the visit date. A participant is counted as attending the visit when the visit date is known. As participants accrue and move through the trial, the report provides an overview of the flow of participants through each stage.
For each visit, by clicking on the corresponding link, you can edit visit details, and duplicate or delete the visit and all of its forms. You can also change the order of visits within the CRF by clicking on the ⋮⋮ symbol next to the label of the visit and dragging it to the right place.