Time zones for studies

How different time zones affect your data in multinational studies.

General Information

Any date and time information in Climedo will always be stored as UTC time (date and timestamp) in the database. However, depending on where the user is located, i.e. which time zone is set on the device of the respective user, the presentation of time & date can differ as UTC time is always converted into the time zone of the user's location. This logic applies to all date & timestamps in Climedo.

Date and time fields

Date and time field values are always displayed according to the user's local time zone device settings in the input forms.

Examples: 

1. Date field value "20/05/22" in Munich time is displayed as "19/05/22" in Alaska (saving 20/05/22 0:00 CET as 19/05/22 22:00 UTC in the database, thus converting it to 19/05/22 13:00 for users in Alaska).
2. As an investigator in Munich, I fill in a date and time field called "When did you take your medication? I enter "18/05/22 20:00" in this field. When my colleague in Tokyo opens the form for the same subject, he/she will see "19/05/22 5:00" as the answer to the same question (saving 18/05/22 20:00 CET as 18/05/22 18:00 UTC in the database, thus converting it to 19/05/22 3:00 for users in Tokyo).

Time based validations

Time-based validations are always triggered according to the user's local time.

Example: 

• A validation is set to display a warning message, if the value from a date and time field is less than 3 hours ago - this time is applied to the time zone the user is in. 
• If the validation is configured in Germany, but the user is located in Portugal, the 3 hours are relative to the local time zone in Portugal.
• If the validation is triggered in Germany, the same validation will be displayed to all users independent from different time zones of the users.

Filter in overviews (incl. subject, query and (S)AE overview)

Filtered data is always based on CET, i.e. although “TODAY” might be different in countries (e.g. in Munich it’s 2nd of June, in London it’s still the 1st of June), filters currently always show CET results.

Example: 

• The date is 18/05/22 22:00 in Munich and 19/05/2022 6:00 in Melbourne. If the filter "YESTERDAY" is applied on 19/05/2022 in Melbourne, the entry created on the above date would be displayed.

Audit Trail

In general, date and time are always displayed according to the local user time zone device settings. This includes:

1. Data entry updates: When date and time fields are updated, the input field data is converted to the respective time zone of the user. Therefore, the time displayed in the audit trail is always the same as in the input form.
2. Timestamps of updates: Timestamps recording when the update event took place are also displayed in the local time zone of the user, including both:
   1. Process events (e.g. input form was signed or locked)
   2. Data entry events
3. Audit Trail Filter: The audit trail timestamp filter always works according to the local time. 
   Example: The date is 18/05/22 22:00 in Munich and 19/05/2022 6:00 in Melbourne. If on 19/05/2022 the filter “yesterday” is applied in Melbourne, the entry would not show up.
   

ePRO scheduling (incl. reminders & expiry)

When configuring the trigger time for a scheduled ePRO, ePRO reminders and ePRO expiries the subject's time zone is taken into account at the time the ePRO is scheduled. This ensures that ePROs are delivered at the correct local time for subjects in different regions, supporting multinational clinical trials. Scheduling settings also take into account any changes in Daylight Saving Time (DST).

A subject's time zone corresponds to the time zone that was assigned to the subject's site. This also means that in rare cases the subject's actual location may not match the site's time zone, e.g. when a subject is on holiday. If the subject is reassigned to a different site with a different time zone, e.g. if they move, any upcoming scheduled ePROs will be sent in the new time zone.

Example: 

• An ePRO is scheduled for the next day at 11:30am in Munich. Patients in Tokyo will also receive the ePRO at 11:30am according to Melbourne time.

Data export

In all data exports (PDF, Excel & CSV), date and time field values and timestamps (e.g. updated at and created at) are currently always displayed in Central European Time (CET). This means that date and time information in Climedo and the data export may differ if the user is not located in the Central European Time Zone. 

As an exception, the locking history & electronic signature history will be exported with UTC timestamps until further notice.

Example: 

• A user is based in London. In Climedo, all date and time fields are displayed in London's time zone. However, when the data is exported, all date and time field values and time stamps are converted into Central European / Berlin time.