Publication date: October 23, 2025
Investigator status
The legal status of an investigator is determined based on Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and the Polish Act of 9 March 2023 on clinical trials on medicinal products for human use .
If a clinical trial is conducted by a team, the principal investigator is the primary investigator. If there is only one person responsible for conducting the clinical trial, the investigator is the primary investigator. This distinction is important because it determines who can, respectively, fulfill the roles of investigator and principal investigator.
The researcher may therefore be a doctor or, pursuant to Article 49 of Regulation 536/2014, a person exercising a profession with the necessary knowledge and experience in working with patients, who is permitted to be a researcher in a given Member State.
If the entire team is responsible for conducting a clinical trial, the principal investigator must be a physician, dentist, nurse, or midwife, as stipulated in Article 37 of the Clinical Trials of Medicinal Products for Human Use Act. This regulation seems appropriate because it allows these professions to prescribe medications independently without medical assistance.
A proposal to include a pharmacist was also made, but this was rejected. However, a pharmacist, like a laboratory diagnostician or other healthcare professionals, may also be part of the research team. However, as stated in paragraph 2, if the principal investigator is a nurse or midwife, the team must include a physician or dentist. The investigators’ qualifications should be presented in the application for permission to conduct a clinical trial.
Under Article 4.1 of the Principles of Good Clinical Practice, the investigator should also be able to formally demonstrate their competence by submitting documents required by the sponsor, the Independent Bioethics Committee, or the relevant authorities. However, the Principles of Good Clinical Practice do not provide any further guidance on whether the investigator should be the most qualified person on the team.
The selection of the principal investigator should be made with due care, as his or her possible replacement is linked, under Article 15 of Regulation No. 536/2014, to the procedure for issuing an authorisation for a substantial modification of a clinical trial.
Under Article 71 of Regulation No. 536/2014, an investigator may also act as a sponsor. This is the next person with status in the clinical trial procedure. Their primary responsibilities include initiating the clinical trial, managing it, and ensuring its financing, as defined in Article 2, paragraph 2, point 14 of Regulation No. 536/2014.
Under Articles 42 and 43 of the Clinical Trials of Medicinal Products for Human Use Act, the Patient is also obligated to make a contribution to the Clinical Trials Compensation Fund before the trial begins. This fund was established to provide financial support to individuals injured as a result of participating in clinical trials that began after April 14, 2023, or to the families of individuals who died as a result of participating in trials.
However, if these two functions are not combined in one person, then pursuant to Article 36 paragraph 1 item 2 of the Act on Clinical Trials of Medicinal Products for Human Use, the sponsor must seek the consent of the investigator or principal investigator (issued in writing) if he or she wishes to obtain access to source documents.
Rights and obligations of the investigator
The investigator or principal investigator has specific rights and responsibilities. Their responsibilities include ensuring that the clinical trial at the clinical trial site complies with the requirements of Regulation No. 536/2014 and that the clinical trial is conducted in accordance with the protocol and the principles of good clinical practice, as set out in Articles 73 and 47.
Four basic responsibilities also include:
– providing comprehensive information about the study conducted and obtaining informed consent from participants to participate in accordance with Article 29 of Regulation No. 536/2014;
– tracking all cases where individuals refused to participate in the study or withdrew from it pursuant to Article 30(4) of Regulation No. 536/2014;
– providing information to the appropriate branch of the Provincial National Health Fund regarding the inclusion of a participant in a clinical trial or its exclusion (within 30 days of the date of occurrence of a given event) pursuant to Article 60 of the Act on Clinical Trials of Medicinal Products for Human Use;
– reporting adverse events and serious adverse events to the sponsor pursuant to Article 41 of Regulation No. 536/2014, taking into account that serious adverse events must be reported within 24 hours of becoming aware of them.
In addition, the investigator also has certain information obligations under Article 56 – he or she shall record, process and store all information relating to the clinical trial in a manner that allows for its accurate reporting, interpretation and verification, while protecting the confidentiality of participants’ records and their personal data in accordance with applicable data protection law.
In addition to the above, the investigator should also keep the clinical trial master records pursuant to Article 57 of Regulation No 536/2014, which, pursuant to Article 58, should be archived for 25 years.
In some cases, the investigator is also responsible for overseeing the administration of medication to the participant and the amount of product dispensed (this procedure must also be properly documented), particularly in smaller research centers. This task may also be performed by a co-investigator or, in larger facilities, a pharmacist.
On the one hand, the investigator, as a responsible person, supervises the entire team and other subcontractors, including delegating tasks within his/her colleagues, and on the other hand, he/she also has many general tasks that result from his/her position:
a/ supervising the level of knowledge and skills of the research staff to ensure the proper conduct of the study;
b/ ensuring the safety of clinical trial participants;
c/ responsibility for each violation of the study protocol;
d/ supervising the course of the study, including the preparation of the final report and being responsible for financial settlements;
e/ ensuring that the protocol is approved by the regulatory authorities and the Bioethics Committee;
f/ ensuring that each person making up the team knows how to perform their duties, has completed the required training, has the required education and is familiar with the protocol and procedures of the study.