How to become a Principal Investigator in Hungary?
- Pavel Shkliaev
- May 5
- 3 min read
Short guide with 2026 updates
I have never participated in clinical trials. Can I become an Investigator or Principal Investigator in Hungary?
Yes. Prior participation in clinical trials is not required to become an Investigator or Principal Investigator in Hungary. Eligibility depends primarily on formal medical qualifications and specific regulatory training, such as a clinical pharmacology specialization or a university-organized Good Clinical Practice (GCP) certificate. This means that physicians NEW TO CLINICAL RESEARCH CAN CANDIDATE FOR PI OR INVESTIGATOR ROLES.
What qualifications are required to be a PI for Phase 1 studies?
For Phase 1 (clinical pharmacology) studies, the Principal Investigator must hold a specialist exam in clinical pharmacology. Phase 1 studies are subject to the most stringent personnel requirements due to their early development and safety focus. Please note that Phase 1 clinical trials can be only conducted at clinical pharmacology sites certified by NNGYK.
What qualifications are required to be a PI for Phase 2 studies?
For Phase 2 clinical trials, the PI must:
hold a medical specialist qualification in the therapeutic area relevant to the investigational medicinal product
hold a clinical pharmacology specialist qualification and complete a university-organized GCP course.
What qualifications are required to be a PI for other clinical trials?
For clinical trials outside Phase 1 and Phase 2, the PI must have a university-organized GCP certificate completed.
Do I need to use a specific CV template to comply with Hungarian clinical trial regulations?
Yes. Hungary requires the use of a standardized Investigator Curriculum Vitae template adopted for Hungary v 2.0. Using this official template ensures that your CV meets the administrative and regulatory expectations of the Hungarian Central Ethics Committee and Authority.
Do I need a separate GCP certificate if I hold a clinical pharmacology specialization?
Yes. Although a clinical pharmacology specialization may fulfill regulatory requirements in certain cases, most sponsors will still require a valid GCP certificate. Therefore, physicians who wish to act as Principal Investigators are strongly advised to obtain and maintain an up-to-date GCP certificate.
What type of GCP training is accepted in Hungary?
Accepted GCP training must be:
organized by a university, and
documented with a certificate clearly stating the completion date.
GCP courses organized solely by CROs or commercial providers may not be sufficient where regulations explicitly require university-organized training.
How long is GCP training valid in Hungary?
Under Hungarian regulatory requirements, GCP training is considered valid for 5 years prior to the start of the clinical trial. However, in practice, many sponsors require GCP certificates issued within the last 2–3 years.
Who can act as a clinical trial site in Hungary?
Both public and private healthcare institutions may serve as clinical trial sites in Hungary. In practice, the requirements may vary depending on the trial phase, as certain phases (e.g., Phase 1) are subject to more specific institutional criteria. Each trial must receive approval from the national competent authority and the relevant Ethics Committee.
Is the Hungarian regulator the only authority who decides whether I can be a Principal Investigator?
No. The national regulator grants the official approval for conducting a clinical trial at a selected site within Hungary. However, before regulatory submission, the SPONSOR — as the main organizer of the trial — selects the trial site and the Principal Investigator.
Sponsor selection criteria may include additional criteria to the above and typically consider factors such as:
physician’s clinical and research experience,
access to the required patient population,
overall site capabilities.
In other words, meeting regulatory requirements is essential — but it is not the only factor.
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