Definition of Expected forms
Note: The definition of expected forms in the Data Viewer is different from the definition used in the Reporting and Analysis module.
In the Data Viewer, a CRF is counted as Expected if it meets any of the following criteria.
- A Started CRF is counted as Expected, regardless of whether its visit was supposed to start.
A dynamic form that is Activated but not Started does not count as Expected. The one case where a Started CRF does not count as Expected is if the subject is not enrolled.
- An ALT form is counted as Expected if the ALT form appears in the InForm user interface.
The ALT form appears in the InForm user interface if the form to which it is an alternate has been started. The calculation does not take into account whether the visit in which the ALT form appears was supposed to start yet.
- Every CRF in the current study version for each subject counts as Expected, unless the following restrictions cause the CRF to NOT be counted as Expected:
- CRFs are only counted as Expected for Enrolled subjects.
- CRFs are only counted as Expected for subjects who have started at least one CRF.
- The date the first CRF is started in the InForm application is the First CRF Date for the subject and is used in some calculations, as follows.
- This First CRF Date is the Server Date/Time when the CRF was entered electronically into the InForm application, which could be after the real-world subject visit when the paper form was filled in.
- This First CRF Date is an internal date in the InForm application, and does not appear in the InForm user interface.
- Only subject visits and the common visit are considered. Other special visits such as screening, enrollment, monitoring and so on, are not considered.
- Only CRFs are considered. Other kinds of forms are not considered.
- Dynamic forms that have been deleted (removed) are not counted as Expected.
- CRFs are only counted as Expected if the visit in which they appear is expected to have started, which is calculated as follows:
- Dynamic visits are Expected if activated and the specified date is more than the dynamic visit’s ProjectedStartHours after the First CRF Date. The ProjectedStartHours is converted to whole days and then truncated before this calculation.
- Repeating Visits and Unscheduled Visits are Expected if the specified date is greater than the date from the Date-of-Visit CRF.
- Scheduled Visits are expected if the specified date is more than the visit’s StartHours after the First CRF Date. The StartHours value is converted to whole days and then truncated before this calculation.
All the calculations to determine if a visit is expected to have started use several dates with varying time zones:
- The First CRF Date is GMT.
- The Date-of-Visit for repeating and unscheduled visits is the value entered by the user in the Date of Visit form. No time zone is entered, so none can be assumed.
- The date specified in the Data Viewer user interface as input for this expected CRF. No time zone is entered, so none can be assumed.
Note: The date a user enters in the Data Viewer is in the local time for the user. The Data Viewer converts the local time to GMT time to find matching expected forms.
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