Study Definition module

 

Completion of eForms and visits

The completion of an eForm or visit determines the scheduling of further eForms and visits. For example, the next cycle of a cycling eForm will not be created until the current eForm cycle is complete, and an eForm with Arezzo scheduling constraints will not be activated until the eForms on which it is dependent are complete. Similarly a new visit cycle is not created until the previous visit cycle is complete.

 

However, an internal trigger on an eForm does not affect the completion of the visit so the eForm does not have to be filled in for the visit to be 'complete'. In particular, if a cycling visit only contains eForms with internal triggers, all visit cycles will be created immediately (because each visit cycle is immediately complete). For a cycling visit, it is advisable to always include at least one eForm that is not cycling and has no internal trigger.

eForm completion

An eForm is complete if it has been saved and contains no mandatory questions with a status of Missing, and all its mandatory question groups are complete.

If the status of a mandatory question is Not Applicable or Not Available, the question is ignored when considering the completion of the eForm (so these questions do not affect completion).

If an eForm has no mandatory questions or groups, it will become complete as soon as it has been opened and saved (even if no responses have been entered).

If every question on an eForm is Not Available, the eForm is not complete (e.g. a blank eForm that has been set to Not Available from the subject schedule).

Visit completion

A visit is complete if all its non-cycling eForms are complete (and none has a status of Not Available). Cycling eForms do not affect the completion of a visit, but all non-cycling forms must have been opened and saved, with all their mandatory questions filled in, and have a status other than Not Available.

If you have any blank (non-cycling) eForms that have been set to Not Available in a cycling visit, these will prevent a new visit cycle being created. You should ensure there is always at least one question on each eForm in a cycling visit that can be answered, e.g. "Is this eForm required?". You can either set all the remaining questions to Not Applicable if the answer is No, or set the eForm to Not Available after answering the initial question (so the eForm status will be OK).

Subject status

A subject's status is only set to OK when all visits are complete. If any visit contains a non-cycling eForm which is blank, the subject status will be Missing even if all other eForms have the status OK.

 

 

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