Repeating eForms and visits

When a user completes the eForms within a repeating visit in Data Entry, an identical visit with uncompleted forms will be inserted into the schedule immediately to the right of the original visit.

Repeating visits should be used when you need to record the same information at an unpredictable number of visits.

Example

A study contains a visit, during which subjects will be given some form of treatment and will undergo a set of blood tests. Depending on the reaction of the subject to the treatment, an indefinite number of such visits may take place.

You would need to create a Treatments eForm and a Blood Tests eForm and place them both in a repeating Treatment visit.

We recommend that you always include a visit date on the repeating visit. This helps to avoid confusion as to which cycle of the visit you are working in.

Note that a large number of visit cycles will result in a wide schedule. This knowledge may affect your schedule layout.

Creating a repeating visit

In the schedule, click in the third row of the visit header - this is the Visit Cycles row. See image Enter the number of cycles that you want this visit to have, and press the Return key or click elsewhere. For an unlimited number of cycles, enter -1 (this will be shown on the schedule as Unlimited).

A repeating visit with unlimited cycles will always display an empty visit cycle on the schedule but this will not cause the subject status to be Missing.

When a user completes a repeating eForm in data entry, a message will be displayed asking if they would like to create a copy of the eForm. A new copy of the eForm is inserted into the schedule immediately beneath the original eForm.

Repeating eForms should be used when you cannot predict the number of times that a certain eForm will need to be filled in.

Example

You need to record adverse events throughout the study but cannot predict how many will occur and how often. You would need a repeating Adverse Event eForm, appearing in each visit. This eForm may not be needed on some visits but on others would be filled in several times.

We recommend that you include an eForm date, and an eForm label where possible. This helps to avoid confusion as to which cycle of the eForm you are working on.

Note that a large number of eForm cycles will result in a long schedule. This knowledge may affect your schedule layout.

 

A repeating eForm will always display an empty eForm cycle on the schedule but this will not cause the visit or subject status to be Missing.

 

It is also possible to set a fixed number of eForm cycles. To do this, create a repeating eForm and then use the Arezzo Composer to set the number of cycles. Note that you must set the eForm to be repeating on the visit schedule before setting the number of cycles, otherwise an error will occur when the data entry user attempts to save the eForm.

You may use repeating forms within repeating visits.

Example

You need to measure an undefined number of lesions on each visit and you do not know at the design stage how many visits will be required. You need a repeating Lesion eForm in an initial Baseline visit, on which you record the initial measurements for each lesion. This repeating eForm would also go into a repeating Assess visit so that the measurements could be recorded for each subsequent visit.

 

When using repeating visits and eForms, remember the following:

• A repeating visit cannot contain repeating forms alone. It must also contain at least one non-repeating eForm with no Internal Trigger.

• If you do create a repeating visit containing only repeating forms, when you close the study, you will be warned that this study will not be available for Data Entry. On attempting to open the study in Data Entry, you will see a similar message explaining that the study cannot be opened.