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Lead investigator in the clinical trials of medicinal products

The duties of the lead investigator in the clinical trial procedure are:

  • to select a sufficient number of tested persons in accordance with inclusive and exclusive criteria of the clinical trial protocol;
  • to verbally or in written form explain to test persons in an understandable way the basic data on the medicinal product in the clinical trial, the purpose and progress of the clinical trial, hazards and benefits for participants in the clinical trial, on the rights and responsibilities of tested persons;
  • to explain to the tested persons the method of selection and an approximate number of participating tested persons in the clinical trial and other possible forms of treatment, their advantages or deficiencies;
  • to acquire from the tested persons or their legal representatives a written statement prior to the start of the clinical trial declaring that they understand the data on the clinical trial and that they participate voluntarily;
  • to guarantee the tested person appropriate treatment during the clinical trial and after it, if the treatment continues or is the consequence of complications during the clinical trial;
  • to guarantee the tested person that their personal data is available only to persons authorised for the clinical trial and that they will be notified on any important information in connection with the clinical trial;
  • to ensure accuracy, completion, legibility and the appropriate timing of data in connection with the clinical trial;
  • to provide for the confidentiality of the secret code of the tested person and the medicinal product in the clinical trial;
  • they can only disclose the secret code according to their judgement in emergency cases;
  • to ensure appropriate storage, registration, issue, use of samples and the storage of unused samples of medicinal products for clinical trials and for their destruction in agreement with the sponsor;
  • to notify the sponsor without delay on any serious adverse events in the clinical trial, except on those for which the testing protocol or the investigator brochure do not determine immediate reporting.

Such immediate reports shall be followed by detailed, written reports. To notify the sponsor in due time determined in the testing protocol on any adverse events and laboratory results which the testing protocol determines as critical in terms of the safety assessment.

In the case of death of tested persons, send the sponsor all additionally required data; in case of immediate danger for the tested person, terminate the clinical trial and notify the sponsor and, if necessary, submit an incentive for changing the testing protocol. In this case, the researcher is obliged to notify all tested persons and guarantee them appropriate therapy and monitoring of their health. The lead investigator in a clinical trial must have appropriate education and experience.

Conditions

  • The principal researcher in a clinical trial of the medicinal product is:

    1. a doctor of medicine or a doctor of dental medicine with a licence
    2. at least two years of experience in the field of clinical trials of medicinal products and
    3. additional education or qualification if this is necessary relating to the relevant clinical trial of a medicinal product.

    Evidence

    Diploma - certified copy or non-certified copy and the original provided on request. Licence - certified copy or non-certified copy and the original provided on request. Certificate of additional education or qualifications

    Legal basis

Recognition of qualifications acquired abroad

There are following systems for the recognition of professional qualifications acquired in the EU:

Cross-border provisions of profession

Performance of the profession in Slovenia is not possible on Cross-border/temporary basis.
Last modified:
8. 9. 2021