Site Monitoring Visit Window Functional Specifications
Visit Window Rationale
In order to facilitate adherence to a study's monitoring plan, create windows to calculate monitor site visit window dates automatically.
Visit Window Mechanics
By visit type, for a timeframe, allow a study admin to create a window for the next visit in sequence.
The next visit is determined by a study administrator on the Visit Types tab (completed in 312).
The visit window has a minimum and maximum number of days for the next visit.
Visits whose first date is in the window's timeframe apply that window's date range to the next visit of the relevant type.
Some visit types are endpoints which do not have a window for a following visit.
Some visit types are "ad hoc" which are not a part of any window, nor affect any subsequent visits' window calculations.
A visit with a single date inside the window's range is considered in the window. If all dates are not in the window, the visit is considered outside.
- Cases when the hyphen will appear for Out of Window Code
First visit in a sequence including when the visit jumps sequence
Visit Type does not have an applicable window but visit windows are turned on
The visit type is ad_hoc
- Cases when nothing will appear
When the visit is out of window but has not been edited to include a code (! shows in status); only for visit that have had windows later added or changed
Visit window is not turned on for the study (no visit-window columns will appear)
Visit type is an endpoint
- IN will appear even if a visit was out of window, given a code, then the window was changed making the visit is in window
Visit Window Interface
Study Administration
The study administrator will have the ability to create visit window timeframe, minimum and maximum date range, endpoint and "ad hoc" values per visit type
Visit Scheduling
When scheduling a new visit, the visit window's dates will appear on the pop-up calendar with green borders
Visits selected in the range will turn a solid green; visits selected outside the window will turn red
If all dates are out of the window, fields to collect data why the visit is out of window will appear: "Out of Window Reason Code" and "Out of Window Reason Description"
Project Managers will be able to approve visits out of the window by editing the record and checking the "Approved" checkbox. Not approving is done by unchecking the checkbox.
Indeterminate is a third state of to allow the manager to reset to the default approval status of NULL.
Visit Reporting
Visit List will have a new filter "Window" with choices "(unfiltered)" (default), "In", "Out / Approved", "Out / Not Approved"
New column "Window Status" to show blank if in or not applicable, green check for out and approved or red triangular ! for out and not approved
New column "Approved" will be blank by default, "No" if unchecked and "Yes" if checked in the schedule
Clicking on any visits' window icon will switch to the edit view of the visit
Visit Summary will show the investigator's next visit when one is present as the system works now. If there is no next visit, the column will show the investigator's visit window, if applicable, instead. If the end date of the window is today or later, the text will be in green. If the end date of the window is prior to the curent date, the text will show in red.
In all places that list the out of window status, the red exclamation point will denote "out-of-window and not approved" and the green check for "out-of-window and approved"
Known Issues
None.
Phase II
New metric in monitor metrics: % visits in window; perhaps leveraging reason "Monitor Non-Compliance"
See visit windows for all visits I wrote this down but don't know what it means
Monitor's manager to have additional input fields when not approving a visit outside the window which show only to managers in reports
Allow visit windows to be saved per site; add pi_person_id to window_site_monitor_visit_types table