Becoming a Principal Investigator in Croatia: short guide with 2026 updates
- May 6
- 3 min read
I have never participated in clinical trials. Can I become a Principal Investigator in Croatia?
The approval process of Principal Investigator in Croatia is flexible and prior participation in clinical trials is not always obligatory. Eligibility depends primarily on formal medical qualifications and holding Good Clinical Practice (GCP) certificate. This means that physicians NEW TO CLINICAL RESEARCH CAN CANDIDATE FOR PI ROLE. However, there is a special local requirement: if you have no prior experience in clinical trials, you must be assigned a Mentor.
Why do I need a Mentor, and how long should the mentoring period last?
The main purpose of the mentoring is to help ensure patient safety and regulatory compliance. This means the Mentor should be a prominent expert in the field, with appropriate experience in conducting clinical trials. At the same time the Mentor does not necessarily have to be one of the principal investigators in the clinical trial in question.
The mentoring period is not defined by a specific timeframe but rather by the investigator’s level of experience. A mentor is assigned on a per-study basis if the proposed PI does not yet have sufficient clinical trial experience. It is not a one-time appointment that automatically continues until the investigator becomes fully independent; instead, the need for mentoring is evaluated depending on the investigator’s experience and the requirements of each study.
What general qualifications are required to be a PI in Croatia?
Clinical trials in Croatia must be conducted by principal investigators who:
Hold an undergraduate and graduate university degree in healthcare
Or integrated undergraduate and graduate university degree in healthcare.
Have relevant additional training if required by the study protocol.
Hold a GCP certificate
Is there a regulatory limit on the number of clinical trials in which I may participate at the same time?
As a PI you can conduct no more than 5 clinical trials simultaneously in the active recruitment phase. This requirement ensures that the PI is able to dedicate adequate time and resources for each trial and its patients.
Are there phase-specific requirements for serving as a Principal Investigator?
For a Phase II trial, the proposed PI must:
Have previously participated in at least 3 clinical trials.
Among those trials, at least one must have been a Phase III trial as Principal Investigator
For Phase III trial, the proposed PI must:
Have previously participated in at least 3 clinical trials of phase III as Co-Investigator.
NB! Depending on the complexity and specificity of each individual clinical trial, the Central Ethics Committee (Središnje Etičko Povjerenstvo / SEP) may exceptionally decide otherwise.
Do I need to use a specific CV template to comply with Croatian clinical trial regulations?
Yes. Croatia requires the use of a standardized CTIS Investigator Curriculum Vitae template. Using this official template ensures that your CV meets the administrative and regulatory expectations of the Croatian Central Ethics Committee and Authority.
What type of GCP training is accepted in Croatia?
GCP training may be provided by:
Accredited training providers,
Sponsors or CROs,
Recognized educational institutions.
Online or in-person formats are generally acceptable, provided certification is documented and verifiable.
How long is GCP training valid in Croatia?
Under Croatian regulatory requirements, GCP training must not be older than 3 years at the time of submission.
Who can act as a clinical trial site in Croatia?
Both public and private healthcare institutions may serve as clinical trial sites in Croatia. In practice, the requirements may vary depending on the trial phase, as certain phases are subject to more specific institutional criteria. Each trial must receive approval from the national competent authority and the relevant Ethics Committee.
Is the Croatian 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 Croatia. 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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