How to become a Principal Investigator in Bosnia and Herzegovina?

We continue to share a series of guides designed to help physicians become Principal Investigators.

1. I have never participated in clinical trials. Can I become a Principal Investigator in Bosnia and Herzegovina? 

Yes. Prior participation in clinical trials is not required to become a Principal Investigator in Bosnia and Herzegovina. This means that physicians NEW TO CLINICAL RESEARCH CAN BE A CANDIDATE FOR PI ROLE. However, depending on the trial prior experience may be expected.

2. What general qualifications are required to be a PI in Bosnia and Herzegovina? 

Clinical trials in Bosnia and Herzegovina must be conducted by principal investigators who: 

•Has at least a medical or dental degree 

•Experienced in the field in which the investigational medicinal product is primarily used 

•Hold a GCP certificate 

3. 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 3 clinical trials simultaneously during one calendar year. This requirement ensures that the PI is able to dedicate adequate time and resources for each trial and its patients. 

4. Are there phase-specific requirements for serving as a Principal Investigator? 

There are no strictly defined phase-specific requirements under the law. Which means that approval process is flexible. 

5. Do I need to use a specific CV template to comply with clinical trial regulations? 

No official template is prescribed. However, in accordance with GCP and Agency (Agencija za Lijekove i Medicinska Sredstva) requirements, the CV must be up to date, signed, and dated. As per general industry practice, a PI’s CV usually includes information on previous medical experience, clinical trial experience, as well as certifications and training. 

6. What type of GCP training is accepted in Bosnia and Herzegovina? 

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. 

7. Since GCP R3 was issued in 2025, is R2 Certificate still can be recognized as valid?   

In ongoing and new clinical trials in Bosnia and Herzegovina that use GCP R2 training as evidence, the Agency will accept certificates issued before 22.07.2025 until their expiration date. All GCP training conducted after 22.07.2025 must be in accordance with ICH GCP (R3).

NB! Sponsors may not further accept R2 training anymore.

8. Who can act as a clinical trial site in Bosnia and Herzegovina?

Both public and private healthcare institutions providing secondary or tertiary care  may serve as clinical trial sites in Bosnia and Herzegovina. 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. Phase I trials are conducted in B&H, but not on healthy volunteers. An additional requirement for phase I is the presence of a clinical pharmacologist in the research team.

9. Is the national 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 Bosnia and Herzegovina. 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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