Multicentre Studies - Study Management - Management - Development

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:

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 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

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 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)
Dedicate time for study conduct and remain motivated throughout its implementation

The SP-INV of the study:

Writes the study protocol, to be complies with and 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 adequate 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. Develops the monitoring plan of the study and selects qualified monitors
In collaboration with participating study site(s), prepares the site-specific study documents 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 the study protocol, and other aspects needed for the successful implementation of the study during 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
Carries out regular safety evaluation and reports safety issues to the EC and Swissmedic, as applicable

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

ICH GCP E6(R2) – see in particular guidelines

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

ClinO – see in particular articles

HRO – see in particular articles

Abbreviations

Development ↦ Management ↦ Study Management ↦ Multicentre Studies

Your Easy Guide to Clinical Studies