PLANREFERENCE OUTLINE

EU Clinical Trial Application Dossier Plan

Dossier plan for a single EU application assessed jointly by every concerned member state: the Part I / Part II split document by document, a validation gate treated as a gate rather than a formality, requests for information with owners and fixed windows, and the downstream modification and results obligations planned before authorisation starts their timetable. Maps to Regulation (EU) 536/2014.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

CHECKING ACCESS

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REGULATIONS MAPPED
Regulation (EU) 536/2014
DOCUMENT TYPE
Plan
LAST UPDATED
August 2026
PURPOSE

A single EU application is assessed jointly by every concerned member state. The architecture is what practitioners must internalise: the dossier splits into a jointly assessed part and a nationally assessed part, and the clock stops in ways that reward a complete first submission. Filing content in the wrong part, or missing a fixed response window, costs a full cycle rather than a comment.

What's Inside

✓Concerned member states, the proposed reporting member state, and the reasoning behind both choices
✓The jointly and nationally assessed split made document by document, each with a named owner and due date
✓Validation readiness treated as a gate, with the completeness check performed before submission rather than after
✓Requests for information logged on arrival with an owner and the fixed window available to answer
✓Per-member-state decisions and conditions recorded, because they can differ on the national part
✓Downstream modification obligations planned in advance, with the owner named before authorisation starts their timetable
✓Results-reporting obligations and their deadlines, owned from the day the trial is authorised

How to Use It

1Keep the jointly assessed part identical across all member states — one conclusion is reached on it, so varying scientific content between states is incoherent.
2Do not file ethics or site-suitability content in the jointly assessed part; misfiled content is found at validation and costs a cycle.
3Treat validation as a gate rather than a formality, because an incomplete dossier costs a full cycle rather than a comment.
4Assign an owner and a deadline to each request for information on arrival — the window is fixed, and a late answer lapses a sound application.
5Plan the modification and results obligations before authorisation, since authorisation starts their timetable whether or not anyone owns them.
6Record per-member-state conditions as they arrive, so a national condition does not surface later as an unmet commitment.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Member States and Roles
2Dossier Split
3Validation Readiness
4Requests for Information
5Decision and Downstream Obligations
REGULATORY CONTEXT

Regulation (EU) 536/2014 governs clinical trials in the EU, including the single application through the portal, the split between jointly and nationally assessed parts, the validation and assessment timetable with its fixed response windows, and the modification and results-reporting obligations that follow authorisation. It does not choose your concerned member states, your proposed reporting member state, or how you resource a response window. Those determinations are the sponsor’s. The planning structure is SPEQ practitioner synthesis.

MAPPED STANDARDS
Regulation (EU) 536/2014
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