Obligations of the investigator

The obligations of the investigator are stipulated by Section 20 of the Act on Medical Devices.

The investigator, and, where a multicentric clinical investigation is concerned, also the principal investigator, shall be obliged to:

  • Safeguard the accuracy, readability, and protection of data about the clinical investigation, data in documents and records about the trial subjects, and, moreover, safeguard compliance with the conditions referred to by Section 18 of the Act on Medical Devices.

Prior to the commencement of the clinical investigation, the investigator shall be obliged to:

  • Request any information considered thereby essential for the conduct of the clinical investigation from the sponsor;

  • Acquaint himself/herself with the relevant scope of the intended purpose of the investigational medical device and manufacturer’s instructions;

  • Properly familiarise himself/herself with the clinical investigation plan, including changes thereto, approve the clinical investigation and endorse it with his/her signature;

  • Provide a written affidavit to the effect that the investigator and his/her staff are able to conduct the clinical investigation and that neither he/she nor his/her staff have any personal relationship to the subject-matter of the clinical investigation which could cause a conflict of interest or interfere with the course of the clinical investigation, particularly with a view to parallel conduct of another clinical investigation in which they are personally involved;

  • Safeguard the assessment of the condition of health of the trial subjects and assess whether the condition of health of trial subjects allows for the commencement of the clinical investigation;

  • Safeguard necessary measures to cover cases of Adverse Events arising from the testing of the medical device within the scope of the conducted clinical investigation

  

In the course of the clinical investigation the investigator shall be obliged to:

  • Record the participation of trial subjects in the clinical investigation;

  •  Inform registering providers – general practitioners or paediatricians about the participation of trial subjects in the clinical investigation;

  • Forthwith inform the sponsor of the clinical investigation about any Adverse Events and Serious Adverse Events arising from the testing of the medical device and about adopted measures;

  • Discuss any necessary changes to the clinical investigation plan with the sponsor of the clinical investigation; such changes may not be implemented without the sponsor’s written approval; this procedure shall not apply in case of a critical situation which might jeopardise the health of trial subjects; such deviations from the clinical investigation plan do not require prior approval by the ethics committee or the sponsor of the clinical investigation, but shall be forthwith notified to the sponsor of the clinical investigation;

  • Check whether the persons involved in the conduct of the clinical investigation duly perform the tasks delegated thereto by the investigator.
       

 Upon completion of the clinical investigation the investigator shall be obliged to:

  • Approve and endorse with his/her signature the final report from the clinical investigation.

The provider of healthcare services shall store the documentation of the clinical investigation for the period of at last 15 years of its completion.

 

Clinical Evaluation of Medical Devices Department

1.7.2015