Development↦Management↦Study Management↦Multicentre 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 study protocol.
In a multicentre study:
- In addition to a SP-INV-site, additional study site(s) 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
More
The initiation of a multicentre study greatly expands SP-INV responsibilities. Reasons for initiating a multicentre study include:
- Access to additional participants: To address a study question, a larger number of participants might be needed than what a single site can provide
- Collaborations: different sites have different expertise; collaboration with other study sites increases study feasibility
- Grant provider: The implementation of a 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:
- Have adequate access to study participants
- Have sufficient qualified staff at disposal, which are trained on delegated tasks and responsibilities (e.g. site delegation-log)
- Are able to comply with the specifications in the study protocol
- Are able to correctly manage the investigational therapeutic product (IMP / IMD) and the biological material (e.g. sample workflow)
- Enter study data correctly and in a timely manner into the study database
- File essential documents in the study Investigator-Site-File (ISF)
- Protect the safety and rights of study participants by complying with safety reporting guidelines (e.g. safety assessment and reporting)
- Follow Quality Assurance guidelines (e.g. study SOPs, WIs, promptly resolve open issues defined during study monitoring)
- Monitor defined milestones, and maintain required study tracking and oversight at all times
- Dedicate time for study conduct and remain motivated throughout its implementation
More
The SP-INV of the study:
- Writes the study protocol, to be complied with and effective in all participating study sites
- Selects qualified sites to participate in the study (e.g. site qualification)
- Acquires adequate funds
- Writes-up contracts with respective partners
- Ensures adequate study insurance
- Ensures the delivery of the investigational therapeutic product (IMP / IMD) to participating study sites
- Adapts participant documents (e.g. ICF, PIS) according to given study site requriements (e.g. additional languages)
- Defines the monitoring strategy of the study. Develops the risk-based monitoring plan of the study and selects qualified monitors
- In collaboration with participating study site(s), prepares the site-specific study documents for Ethics Committee (EC) submission and approval. In the event of a risk-category B or C study, submits the study to Swissmedic for IMP / IMD study approval.
- Sets-up and validates the study database
- Trains site staff on the study protocol, and other aspects needed for the successful implementation of the study during conduct
- Establishes a risk-based Quality Management System (QMS)
- Provides sites with required documents filed in the ISF
- Defines procedures regarding safety assessment and reporting to EC and, as applicable, Swissmedic
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
References
ICH GCP E6(R2) – see in particular guidelines
- 3. SP-INV responsibilities
- 3.7 Investigator Selection
- Glossary: Definition multi-centre study
ISO 14155:2020 Medical devices (access liable to cost)
Swiss Law
ClinO – see in particular article and annexes
- Art. 27 Multi-centre clinical trials
- Annex 3 Ethics application multi-centre studies
- Annex 4 Swissmedic application multi-centre studies
ClinO-MD – see in particular article
- Art. 13 Multi-centre clinical trials
- Annex Ethics and Swissmedic application multi-centre studies
HRO – see in particular articles
- Art. 17 Multi-centre research projects
- Annex 2 - 8 Ethics application multi-centre studies