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 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

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 relevant to the study
Have qualified staff at disposal which are trained on delegated tasks and responsibilities (e.g. site delegation-log)
Are well informed and able to follow study protocol procedures
Are able to correctly manage the investigational product (e.g. IMP/IMD) and biological material (e.g. sample workflow)
Enter study data correctly and promptly 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, 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

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

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