Serious Adverse Event (SAE) reporting

A Serious Adverse Event (SAE) shall mean an adverse event which has caused:

A) Death;

B) Serious deterioration of the trial subject’s state of health which resulted in:

  • a life-threatening disease or injury to health,
  • a permanent damage to a body structure or function,
  • hospitalisation of the trial subject or prolonged hospitalisation, or
  • the necessity to perform a medical procedure to prevent a life-threatening disease, injury to health, permanent damage to a body structure or function; or

C) A jeopardy to the foetus, death of the foetus, a congenital abnormality or damage to the newborn during delivery.

 

Scheduled hospitalisation, hospitalisation for a pre-existing condition, or a procedure required by the clinical investigation plan, without serious deterioration of the state of health, shall not be considered SAEs.

The investigator shall be obliged to forthwith notify the sponsor of the clinical investigation of any Adverse Events and Serious Adverse Events arising from the testing of the medical device.

The sponsor shall be obliged to assess, together with the investigator, any Serious Adverse Events arising from the testing of the medical device and to forthwith inform other investigators, the Institute and the ethics committee as they arise.

The particulars of Serious Adverse Event reporting to the Institute are set forth by Section 2 of Decree No 62/2015 Coll., implementing some provisions of the Act on Medical Devices.

Serious Adverse Event reports shall be filed using the form for the reporting of Serious Adverse Events in compliance with the guideline of the European Commission for Serious Adverse Event reporting.

 

SAE Reporting Form

SAE Reporting Form

Annex to MEDDEV 2.7

 

 

The sponsor of the clinical investigation shall report to the Institute Serious Adverse Events via an electronically completed Serious Adverse Event Reporting Form signed with a certified electronic signature in the Czech or English language.

 

Where the clinical investigation is conducted using also medical devices for which conformity has been assessed (which are CE-marked) and during their use an event occurred which resulted or could result in a serious deterioration of the state of health or death, such events shall be reported as adverse incidents in compliance with Section 70 of the Act on Medical Devices.

 

A Serious Adverse Event in a clinical investigation of a medical device commenced prior to the effective date of the new Act on Medical Devices and uncompleted by this date shall be reported to the Institute in compliance with existing legal regulations, both by the sponsor and the investigator:

Serious Adverse Event reporting pursuant to existing legal regulations

  • The investigator shall be obliged to forthwith inform the sponsor, or the sponsor’s assistant, if applicable, the concerned ethics committee, and the Institute about the arising SAE and about adopted measures.

  • The investigator may inform about the arising SAE in the form of a written description of the event sent to the Institute by means of a letter, fax or e-mail message or by sending a copy of a completed SAE reporting form of the trial subjects Case Report Form (CRF).

 

 

  • The sponsor shall be obliged to forthwith inform the Institute about any SAEs as they arise. The information shall be sent by means of the SAE reporting form. The form is part of the recommending guideline MEDDEV 2.7/3 Clinical investigations: Serious Adverse Event reporting, which has been published by the European Commission to achieve a joint approach by all stakeholders to the obligations set forth by European directives governing SAE reporting.

  • The sponsor shall be obliged to inform the investigators in writing about any SAEs arising from clinical investigations conducted at several sites within 10 days of the day of learning thereof.

 

 

Clinical Evaluation of Medical Devices Department

1.7.2015