What is it? Why is it important?

A Multicentre study is a study that is conducted at more than one site, but according to a single study protocol.


In a multicentre study:

  • In addition to a SP-INV-site, additional study sites participate in the study
  • Each additional study site has its own Site-INV 
  • Each Site-INV is responsible for the conduct of the study at its own site 
  • Each site must comply and follow specifications defined in the study protocol


Multicentre studies can involve more than one Ethics Committee (EC).

  • The EC responsible for the SP-INV-site and the approval of the multi-centre study, takes on the role of the lead-EC
  • The SP-INV submits all required study documents to the lead-EC who forwards applicable information to local-EC(s). Local-EC(s) are responsible for any additional participating study sites under their jurisdiction


The initiation of a multicentre study greatly expands SP-INV responsibilities. Reasons for initiating a multicentre study might be:

  • Access to additional participants: In order to answer a study question, more participants are required than what single site can provided
  • Collaborations: different sites have different expertise; collaboration with other study sites increases study feasibility
  • Grant provider: Multicentre study is a funding criterion

What do I need to do?

Clearly differentiate between SP-INV responsibilities versus the reduced responsibilities of the Site-INV.


The SP-INV must ensure that all sites:


The SP-INV of the study:

  • Writes the study protocol, which is effective in all participating study sites
  • Selects qualified sites to participate in the study
  • Acquires adequate funds
  • Writes-up contracts with respective partners
  • Ensures adequate study insurance
  • Ensures IMP/IMD transport and delivery
  • Adapts participant documents (e.g. ICF, PIS) according to given study site requriements (e.g. additional languages)
  • Defines the monitoring strategy of the study in the monitoring plan, and selects qualified monitors
  • In collaboration with participating study site(s) prepares the site specific essential documents required for EC submission and approval. In the event of a risk-category B or C study, submits the study to Swissmedic for approval.
  • Sets-up the study database
  • Trains site staff on study protocol, and other aspects for successful study conduct
  • Establishes a risk-based Quality Management System
  • Maintains study oversight and monitors milestones and timelines
  • Provides sites with required documents filed in the ISF
  • Keeps ongoing safety evaluation and reports safety issues to the EC and Swissmedic, as applicable

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic


ICH GCP E6(R2) – see in particular guidelines

  • 1.40 Multi-centre study definition
  • 5.23Multi centre trials


ISO 14155:2020 Medical devices (access liable to cost)

Swiss Law

ClinO – see in particular articles

  • Art. 27 Multi-centre studies
  • Annex 3 - 4 Ethics application multi-centre studies

HRO – see in particular articles

  • Art. 17 Multi-centre research projects
  • Annex 2 - 8 Ethics application multi-centre studies
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • HRO – Human Research Ordinance
  • ICF – Informed Consent
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • PIS – Participant Information Sheet
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Development ↦ Management ↦ Study Management ↦ Multicentre Studies

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Development ↦ Management ↦ Study Management ↦ Multicentre Studies

Please note: the Easy-GCS tool is currently under construction.