PLANREFERENCE OUTLINE

GLP Multi-Site Study Arrangement

Arrangement for a study split across sites without splitting responsibility for it: phases and sites named in the plan itself, a principal investigator per delegated phase reporting to the study director, quality-assurance coverage agreed rather than assumed, raw data ownership and transfer, deviations routed without delay, and one final report with signed contributing reports attached. Maps to the OECD GLP Principles.

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.

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REGULATIONS MAPPED
OECD GLP Principles
DOCUMENT TYPE
Plan
LAST UPDATED
August 2026
PURPOSE

Phases of a study are delegated to principal investigators at test sites while the study director retains overall responsibility for the study and its final report. The arrangement fails when delegation is read as transfer — a phase no quality assurance unit inspected, or a deviation that reached the study director weeks late, both follow from that one misreading. Who holds what is the study director’s to state explicitly.

What's Inside

✓Phases, sites, countries and monitoring authorities named in the study plan itself rather than in correspondence
✓A principal investigator identified for each delegated phase, with the limits of that delegation stated
✓Quality assurance coverage agreed per phase and per site, so no phase ends up inspected by nobody
✓Raw data ownership, the transfer arrangements between sites, and the final archive location
✓Deviation routing to the study director, with the elapsed time between occurrence and notification recorded
✓Communication arrangements, including who acts when the study director cannot be reached in time
✓Report consolidation into one final report, with signed contributing reports attached rather than summarised

How to Use It

1Name every phase and site in the study plan itself; sites added by correspondence leave the plan describing a study that was not run.
2Hold both statements true at once — the principal investigator carries the phase, and the study director still carries the study.
3Agree quality assurance coverage explicitly per phase, or a phase ends up inspected by nobody with each unit assuming the other had it.
4Record where raw data lives at each stage and where it finally archives, because data left at a test site is data you cannot produce.
5Route deviations to the study director without delay and record the delay, so the accountable person learns while they can still act.
6Attach signed contributing reports to the final report rather than paraphrasing them; a summary cannot be audited back to its author.
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
1Phases and Sites
2Principal Investigators
3Quality Assurance Coverage
4Raw Data Ownership and Transfer
5Deviation Routing
6Report Consolidation
REGULATORY CONTEXT

The OECD Principles of Good Laboratory Practice provide for multi-site studies through principal investigators at test sites, with the study director retaining overall responsibility for the study, the study plan and the final report, and with quality assurance coverage required across the sites involved. They do not allocate your phases, choose your archive location, or set the notification time you treat as acceptable for a deviation. Those determinations belong to the sponsor and the study director. The arrangement structure is SPEQ practitioner synthesis.

MAPPED STANDARDS
OECD GLP Principles
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