Create Visits and Procedures Page

[anastath]

UPDATE on 18/08

1) Each Visit should have a number of Procedures and not vice versa. (TBD with business if this change should be reflected in the Sponsor app UI) 2) Each Visit should be scheduled at a predefined date from the previous Visit including an offset. (e.g.second Visit should be scheduled 7 days after the first visit +- 1 day). Within the Sponsor app, there is no need to define date and time of each Visit, the Sponsor just assumes one starting date (D0) for the Trial and defines the period between this date and all other Visits dates. 3) Information that should be sent by Sponsor app to the HCO app, for each Visit:

• Serial Number of the Visit and Name of the Visit
• Predefined period from starting date (D0) + an offset period
• Name of the procedures
• Visit details, and Things to remember

[anastath]

• First focus on Information flow between Sponsor app and HCO app, then on UI changes (updated Visits and Procedures wireframe, update the Visits and Procedures current implementation, etc. )
• Natassa TO-DO:: Check with business people if the Sponsor UI should also change perspective (i.e., each Visit to have a number of Procedures, or Vice versa). The thing is, that the Sponsor may view Procedures and their Visits and HCO + Patient may view Visits and their Procedures (cross check with business)
• • EDIT 25/08: feedback from business: Sponsor should add Visits and then associate Procedures with each Visit. We keep the current orientation (Visits are added horizontally as lines)

[anastath]

UPDATE on 25/08

The Visits and Procedures page in Sponsor should follow the logic of the Flow chart below

• Please note that the randomisation Visit (corresponds to Visit 2 in flowchart above), corresponds to the randomisation date (aka Time 0) and all periods are calculated based on this date. This Visit should be somehow marked (e.g. with a different colour, a checkmark, or whatever) to be distinguised from other Visits.
• For each Visit, a period and a time window in days should be inserted. The time window is calculated in days. It could plus or minus some days from the period. Minus days might be different from plus days (e.g. for a Visit, we could have period to be 2 weeks from the randomisation date and time window to be - 2 days + 3 days).
• I think it is reundant to have period in both weeks and days, we can have only weeks.

[anastath]

Attaching one more flowchart sent as an example. Main difference is that it contains two Visits before the randomisation Visit (V1a 'Screening', and V1b 'Pre-baseline') but the logic behind remains the same i.e. reference date (aka Time 0) refers to the randomisation Visit and all period are calculated based on this reference date.

[anastath]

UPDATE on 08/09

When the Sponsor adds a new Visit s/he should be presented with a checkbox to check whether the newly added Visit is the randomisation visit or not.

• If checked, only one field for period should appear prefilled with 0 and not editable. No visit window should appear for the randomisation visit (The randomisation vist has always 0 days visit window)
• If not checked, period should be available with two editable fields (+ and - weeks) and no Visit window
• After being checked, period should be available with one editable field (+ weeks) and Visit window should be available with two fields (- + days)