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 protocol.

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

More

Multicentre studies can involve more than one EC.

  • The EC responsible for the SP-INV-site takes on the role as lead-EC
  • The SP-INV submits all required study documents to the lead-EC who forwards applicable information to local-EC(s) responsible for additional participating study sites

In multicentre studies:

  • In collaboration with participating study site(s) the SP-INV is responsible to prepare site specific essential documents required for EC submission and approval
  • If applicable, the SP-INV is responsible for submission to RA (e.g. Swissmedic)

Initiating a multicentre study greatly expands SP-INV responsibilities, and should be well thought through.

Reasons for initiating a multicentre study might be:

  • Participant access: In order to answer the study question, more participants are required than what can be provided at one site alone
  • 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.

SP-INV must ensure that all sites:

  • Have qualified staff
  • Are well informed and able to follow protocol procedures
  • Are trained on delegated tasks and responsibilities
  • Enter study data correctly and promptly into the study database
  • File essential documents in ISF
  • Protect the safety and rights of study participants
  • Follow safety reporting guidelines
  • Follow Quality Assurance guidelines
  • Remain motivated throughout the study

More

The study SP-INV:

  • 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/MD transport and delivery
  • Adapts study documents for participants (e.g. additional languages)
  • Defines the monitoring strategy in the monitoring plan and select qualified monitors
  • Submits study documents to EC/RA 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 Investigator site file
  • Keeps ongoing safety evaluation and reports safety issues to the EC and RA, as applicable

Where can I get help?

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

References

ICH GCP E6(R2) – see in particular guidelines

  • 1.40 Multicentre study definition
  • 5.23Multi centre trials

ISO 14155:2020 Medical devices - see in particular sections (access liable to cost)

Swiss Law

ClinO – see in particular articles

  • Art. 27 Multicentre studies
  • Annex 3 - 4 Ethics application multicentre studies

HRO – see in particular articles

  • Art. 17 Multicentre research projects
  • Annex 2 - 8 Ethics application multicentre studies
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EC/RA - Ethics Committee / Regulatory Authorities
  • HRO – Human Research Ordinance
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
  • IMP/MD – Investigational Medicinal Product/Medical Device
  • QMS – Quality Management System
  • RA – Regulatory Authorities
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
Development ↦ Management ↦ Study Management ↦ Multicentre Studies
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

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

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