Development↦Management↦Study Management↦Multi-centre Studies
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
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
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n 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
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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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
References
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