Sponsor duties and SUSAR reporting in Switzerland

Sponsor duties and SUSAR reporting

The sponsor carries the trial: protocol, GCP compliance, monitoring, safety, amendments, insurance and archiving. In safety terms the chain is fixed. Investigators report serious adverse events to the sponsor within 24 hours, and the sponsor reports SUSARs to Swissmedic and the ethics committee within 7 or 15 days.

Last reviewed: 2026-09-17

Reading time: 5 min

Reviewed by Swiss Pharmacovigilance

Who is the sponsor?

The sponsor is the person or institution that takes responsibility for initiating, managing and financing a clinical trial in Switzerland. In industry trials it is the company; in investigator-initiated trials it is usually the hospital or the investigator. A sponsor established abroad needs a representative in Switzerland who can be reached by the authority and the ethics committee.

The duties are continuous rather than a set of gates. Each one produces a record, and the trial master file is the place those records live. An inspection reads the file, not the intention.

A protocol and a statistical analysis plan, kept under version control
GCP compliant conduct, with trained investigators and delegation logs
A risk based monitoring plan, executed and documented
Safety assessment and reporting, with SUSAR triage and the annual safety report
Substantial amendments approved before they are implemented
Insurance in force for the whole trial and all sites
The trial master file, archived for the required period
Notification of the end of the trial and a final report

The safety reporting chain

Safety reporting runs in two hops. The investigator reports serious adverse events to the sponsor within 24 hours of becoming aware of them. The sponsor then assesses each event for the three SUSAR attributes, suspected, unexpected and serious, and reports the ones that qualify to Swissmedic and the ethics committee on the 7 or 15 day deadline.

Unexpectedness is judged against the investigator's brochure, or against the product information for an authorised product. That reference document is therefore a safety document, not an administrative one, and every version change can change what is reportable.

Who reports what, to whom, and by when
Event	Who reports	To whom	Deadline
Serious adverse event at a site	Investigator	Sponsor	24 hours
Fatal or life threatening SUSAR	Sponsor	Swissmedic and the ethics committee	7 days
Other SUSARs	Sponsor	Swissmedic and the ethics committee	15 days
Safety or protective measure taken urgently	Sponsor	Swissmedic and the ethics committee	Without delay
Annual safety report	Sponsor	Swissmedic and the ethics committee	Annually, for the trial duration
End of trial, or premature termination	Sponsor	Swissmedic and the ethics committee	As set by the ordinance, with reasons
Final report	Sponsor	Ethics committee, register	After the end of the trial

The 7 day clock runs over the weekend

A fatal SUSAR notified on a Friday afternoon leaves you the weekend inside the deadline, not outside it. A trial without named on-call cover and a documented fallback for the person who assesses causality will miss this deadline eventually.

The first 24 hours after a fatal SUSAR

The aim of the first day is not the report, it is the decision: is this a SUSAR, and does anything at the sites have to change now. Do those two things in parallel and the 7 day submission becomes a writing exercise rather than a scramble.

Record the date and time of first awareness. That is your day 0 for the 7 day deadline.
Collect the minimum facts: participant identifier, treatment allocation where unblinding is allowed, event, course, outcome.
Assess the three attributes: suspected, unexpected against the investigator's brochure, serious.
Decide with the medical lead whether an urgent safety measure is needed at the sites.
Inform the sites and, where a measure is taken, notify the authority and committee without delay.
Prepare and submit the SUSAR report inside 7 days, and log the acknowledgement.

The annual safety report and the final report

The annual safety report summarises the safety experience of the trial over the reporting year: exposure, the SUSARs reported, other relevant findings and the sponsor's conclusion on whether the risk-benefit balance still holds. It goes to Swissmedic and the ethics committee for as long as the trial runs.

At the end, the sponsor notifies the end of the trial, gives reasons for any premature termination, and files the final report. The results also have to be posted in the register used at registration. Teams routinely underestimate this last step and finish the science months before they finish the file.

Frequently asked questions

What is the difference between an SAE and a SUSAR?

A serious adverse event is any serious event in a participant, whatever its cause. A SUSAR is an event that is additionally suspected to be caused by the investigational product and unexpected against the reference safety information. Investigators report SAEs to the sponsor; the sponsor reports SUSARs to the authorities.

Do we report SUSARs from foreign sites of the same trial?

SUSARs arising in the trial are assessed globally by the sponsor, and those relevant to the Swiss part of the trial reach Swissmedic and the ethics committee. Set the scope out in the safety management plan so the sites and the safety team work to the same rule.

Who assesses causality, the investigator or the sponsor?

Both. The investigator gives an assessment for their case, and the sponsor makes the overall assessment for reporting. If either considers the event related, it is treated as suspected.

Can a CRO take on the sponsor duties?

A CRO can perform the tasks, but the sponsor remains responsible in law. Put the delegated tasks, the deadlines and the escalation path in the contract, and keep evidence that you oversaw the delegation.

What counts as an urgent safety measure?

Any action taken to protect participants from an immediate hazard, such as suspending recruitment, unblinding, changing a dose or amending the monitoring. You may act first and notify immediately afterwards; the notification is not a precondition for protecting participants.

Does the annual safety report replace the PSUR?

No. The annual safety report covers the clinical trial. A PSUR covers an authorised product on the market. A product that is both in trials and authorised needs both, with consistent underlying data.