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Planning decision and service continuity around country holidays

In a multinational trial, one team's ordinary working day may be another country's public holiday.

Representative research photograph: Planning decision and service continuity around country holidays
Photo: U.S. Marine Corps photo by Staff Sgt. Sean Potter · License: Public domain · Cropped and resized.
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In a multinational trial, one team's ordinary working day may be another country's public holiday. Adding holidays to a calendar helps but is insufficient by itself. Sponsors should establish who can make necessary decisions and how critical services will operate during planned absences.

Decision framework

Distinguish public holidays, supplier working days and company shutdowns. Appropriate regulatory owners should verify legal or system-specific time calculations; the project calendar should not automatically generate a legal interpretation. Necessary medical and operational contacts for continuing participant activities need a separate, explicit arrangement.

Worked example

For example, a document approval date falls on a local holiday while the translation supplier elsewhere remains open. Starting translation before the final version is released could create avoidable rework. The team identifies an authorised deputy or a realistic alternative schedule in advance. Calendar differences do not justify uncontrolled use of a draft.

Implementation checks

  • Display critical pending approvals together with authorised deputies before approaching holiday periods affect the relevant teams.
  • Test emergency contact details and the scope of supplier coverage through a realistic desk-based example.
  • Assess the likely backlog after the holiday instead of placing an unrealistic collection of deliveries on the first working day.

Acceptance and boundaries

Accept the plan when teams can route a critical matter appropriately despite planned absences. Do not assume that every service operates continuously; explain the agreed coverage. Obtain confirmation through applicable local processes rather than inventing deputy authority or automatic extensions of deadlines.

Frequently asked questions

Do holidays extend every deadline?
No. Applicable calculations should be checked against the relevant rules, system and process.
Is a general emergency telephone number sufficient?
Not unless its scope, response authority and routing arrangements are understood.

Sources

  1. EMA — ICH E6 good clinical practice
  2. EMA — CTIS sponsor handbook and support