5. Investigator and Investigational Product

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?  

Yes, the principal investigator shall hold the “required qualifications”.

See: Art 37(1) of the Act of March 2023 

“The principal investigator in a clinical trial of a medicinal product conducted in the territory of the Republic of Poland may be:

1) a physician;

2) a dentist;

3) a nurse or a midwife with a diploma of graduation in nursing or midwifery.

(2) In the case referred to in paragraph (1)(3), one of the investigators shall be a physician or dentist.”

By Art 2 of the Pharmaceutical Law 2001 (consolidated text):

“An investigator shall mean a physician, or a dentist if the clinical trial is related to dentistry, or a veterinarian in the case of a veterinary clinical trial, holding the professional license in the territory of the Republic of Poland and adequately high professional qualifications, scientific knowledge and experience in work with patients, necessary for the conducted clinical trial or veterinary clinical trial, responsible for conducting these trials at the given site; if the clinical trial or the veterinary clinical trial is conducted by a team of persons, the investigator designated by the sponsor, with consent of the manager of the healthcare establishment where the clinical trial is conducted, shall be the team manager responsible for conducting this trial at the given site.”

Art 2 of the Medical and Dental Professions Act of 5^th December 1996 provides for the qualifications necessary for a ‘physician’ and a ‘dentist’.  

“Article 2 (1) Practice of the profession of a physician shall consist in the provision of health services by a person having the required qualifications, confirmed by appropriate documents, in particular: examination of the state of health, diagnosis and prevention of diseases, treatment and rehabilitation of patients, providing medical advice, as well as issuing medical opinions and judgments.

(2) The practice of the profession of dentist shall consist in the provision by a person with the required qualifications, confirmed by appropriate documents, of the services specified in paragraph 1, in the field of diseases of the teeth, oral cavity, craniofacial part, and adjacent areas.”

5.2 Does local regulation require any specific documents if PI/CI is based outside the country?

No, not that we have been able to determine but it may not be possible for a PI/CI to be based outside of Poland.

5.3 Does local authority allow electronic ICF administration, including electronic signatures?

Yes, if RA and EC approval has been provided.                                               

Please refer to sections 7.7 and 7.8 of this guidebook. 

5.4 Does local regulation require ICF to be administered as audio/visual and do these need to be recorded?

No, not that we have been able to determine.

5.5 Is there any specific information/requirement on data capture/management (e.g., privacy regulations, etc.)?

Art 8 of the Act of March 2023 provides that:

“In the implementation of clinical trials which are scientific trials, it is permissible the application of articles 15, 16, 18 and 21 of the Regulation (EU) 2016/679 (GDPR) on the protection of the natural person with regard to the processing of personal data …where it is likely that the right provisions will prevent or seriously impede the achievement of the objectives of the clinical trial and where those restrictions are necessary to ensure that objectives are achieved.” 

Art 4 provides that:

“When processing personal data obtained for the purposes of a clinical trial and during that trial, the data controller implements appropriate technical and organizational security measures referred to in Art. 32 sec. 1 of Regulation 2016/679 [the GDPR regulation] taking into account in particular the nature of personal data processed in a clinical trial and the risk of violating the rights or freedoms of persons whose data is processed in connection with the conducted clinical trial.”

Art 36 (2) sets forth the sponsor’s obligations on the processing of personal data as storage of data on computer systems:

"2. If methods based on electronic data storage systems are used to process data obtained in connection with a clinical trial for scientific purposes to the extent necessary to conduct the clinical trial, the sponsor, before starting the processing of these data, is obliged to:

1) provide written instructions for using the electronic data storage system;

2) document that the electronic data storage system was introduced after assessing the security of its use and functionality;

3) ensure access to the IT system for storing data and changing data in such a way that it is possible to retrospectively verify the introduced data changes, which should be understood as the method of keeping clinical trial documentation enabling backward tracing of the course of the trial and all related events and decisions made;

4) indicate persons authorized to process personal data in electronic systems for storing data obtained in connection with the clinical trial.

3. If the collected data is processed, the sponsor ensures the possibility of comparing the processed data with the original data.

4. The Sponsor allows personal data to be processed only by persons with written authorization issued by the data administrator. Persons authorized to process personal data undertake in writing to keep them confidential." 

Additionally, the EMA’s final guidance of 09 March 2023 on Computerized Systems and Electronic Data in Clinical Trials, includes the following:

“6.1. Data capture and location 

The primary goal of data capture is to collect all data required by the protocol. All pertinent observations should be documented in a timely manner. The location of all source data should be specified prior to the start of the trial and updated during the conduct of the trial where applicable. 

6.1.1. Transcription 

Source data collected on paper (e.g. worksheets, paper CRFs or paper diaries or questionnaires) need to be transcribed either manually or by a validated entry tool into the EDC system or database(s). In case of manual transcription, risk-based methods should be implemented to ensure the quality of the transcribed data (e.g. double data entry and/or data monitoring).

6.1.2. Transfer 

Trial data are transferred in and between systems on a regular basis. The process for file and data transfer needs to be validated and should endure that data and file integrity are assured for all transfer. 

Data that is collected from external sources and transferred in open networks should be protected from unwarranted changes and secured/encrypted in a way which precludes disclosure of confidential information. 

All transfers that are needed during the conduct of a clinical trial need to be pre-specified. 

Validation of transfer should  include appropriate challenging test sets and ensure that the process is available and functioning at clinical trial start (e.g. to enable ongoing sponsor review of diary data, lab data or adverse events by safety committees). Data transcribed or extracted and transferred from electronic sources and their associated audit trails should be continuously accessible (according to delegated roles and corresponding access rights). 

Transfer of source data and records where the original data or file is not maintained is a critical process and appropriate considerations are expected in order to prevent loss of data and metadata. 

6.1.3. Direct capture 

Direct data capture can be done by using electronic data input devices and applications such as electronic diaries, electronic questionnaires, and eCRFs for direct data entry. Where treatment-related pertinent information is captured first in a direct data capture tool such as a trial participant diary, a PRO form or a special questionnaire, a documented procedure should exist to transfer or transcribe information into the medical record, when relevant.

Direct data capture can be done by automated devices such as wearables or laboratory or other technical equipment (e.g. medical imaging, electrocardiography equipment) that are directly linked to a data acquisition tool. Such data should be accompanied by metadata concerning the device used (e.g. device version, device identifiers, firmware version, last calibration, data originator, timestamp of events). 

6.1.4. Edit checks 

Computerized systems should validate manual and automatic data inputs to ensure a predefined set of validation criteria is adhered to. Edit checks should be relevant for the protocol and developed and revised as needed. Edits checks should be validated and implementation of the individual edit checks should be controlled and documented. If edit checks are paused at any time during the trial, this should be documented and justified. Edit checks could be either run immediately at data entry or automatically during defined intervals (e.g. daily) or manually”. 

5.6 If a clinical study involves the study product as OTC and this is provided via pharmacy/amazon, etc., are there any specific regulations for IP management that need to be followed?

The EU CTR 536/2014 does not mention OTC but instead, they are using the term of Auxiliary Medicinal Product (AMP), which is defined in Art 2 (8) as “a medicinal product used for the needs of a clinical trial as described in the protocol, but not as investigational medicinal product”.

Art 2. (10) goes further on the AMP clarification indicating: “a medicinal product authorized in accordance with Regulation (EC) No 726/2004, or in any Member State concerned in accordance with Directive 2001/83/EC, irrespective of changes to the labelling of the medicinal product, which is used as an auxiliary medicinal product”.

In March 2024, the EMA updated the recommendations on “Auxiliary Medicinal Products in Clinical Trials”. These recommendations can also be found in Chapter III- Quality section under the Eudralex Volume 10. This publication provides additional clarifications, such as:

“Examples are medicinal products used as rescue medication, challenge agents, to assess end-points in the clinical trial, or background treatment. Further, the medicinal product should be related to and relevant for the design of the clinical trial, which excludes ‘concomitant medications’. As outlined in preamble 54 concomitant medications is unrelated to the clinical trial and not relevant for the design of the clinical trial”. For further definition and examples, see Annex 1 of this document."

Therefore, an authorized or marketed medicinal product (i.e.: Auxiliary Medicinal Product) used in a clinical trial will need to comply with the requirements set within the EU CTR and will be labeled accordingly.

5.7 For a marketed study product/OTC, can a participant be compensated after confirmation of the purchased study product, or upfront prior to product acquisition? Does compensation in any way impact how the study is viewed (i.e., RWE vs. Interventional Study)?

Yes, subject to limitations.

Art 37 K of the Act of 6^th September 2001 – Pharmaceutical Law provides that "the Sponsor….in particular provides investigational medicinal products, comparators and devices free of charge to clinical trials participants .”

5.8 Is it permitted to pay participant stipends (i.e., is it permitted to pay the patients for their participation in the clinical trial)? If so, what is the average range?

Yes, subject to limitations.

The Supreme Bioethics Committee has issued a guideline on “Remuneration of clinical trial participants” that provides additional clarifications.

5.9 Specific labeling requirements for clinical study product

Yes, these are set out in Chapter X, Article 66, and Annex VI of the EU CTR 536/2014.

Art 10.1 of the Act of March 2023 provides – among other things – that:

“(2) Additional information provided on the packaging of the investigational medicinal product and auxiliary medicinal product within the meaning of Article 2 (2) (8) of Regulation 536/2014 shall be labeled in Polish in accordance with Articles 66-68 of that Regulation.” 

The key additional information set out in Art 66 of Clinical Trial Regulation (EU) 536/2014 includes:

“(a) information to identify contact persons or persons involved in the clinical trial; 

(b) information to identify the clinical trial; 

(c) information to identify the medicinal product; 

(d) information related to the use of the medicinal product.” 

Additionally, on 13^th December 2022, the European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) published their Recommendation Paper on Decentralized Elements in Clinical Trials which includes the following information:

5.10 What documents need to be submitted (including relevant fee if any), and to whom, if a permit is needed for an investigational/study product being shipped from outside the country? Are there any specific requirements for biologics?

If the product is being imported from outside the EEA, then the Office President’s certificate attesting that the clinical trial has been entered in the Central Register of Clinical Trials is required. If importation is from within the EEA, then no such certification is required. 

According to Art 37K of the Pharmaceutical Law of 2001:

“(3) Import of investigational medicinal products and equipment necessary for conducting clinical trials shall require the Office President’s certificate attesting that the clinical trial has been entered in the Central Register of Clinical Trials and that the product or equipment concerned is imported for the purposes of such trial.

(4) The provision of paragraph 3 shall not concern the import of investigational medicinal products and equipment necessary for conducting clinical trials from a European Union Member State or a European Free Trade Association (EFTA) Member State – party to the Agreement on the European Economic Area.”

5.11 What is the turn-around time to get an import permit?

If the importation of the investigational product is from within the EEA, then no import permit is required. If the product is being imported from outside the EEA, then the Office President’s certificate attesting that the clinical trial has been entered in the Central Register of Clinical Trials is required.

For import license, it takes 90 days from the date of submitting the import request. 

For relevant products, see the following form which is required to be completed in accordance with the Health Regulation of 29th April 2019 on the form for applications for licenses to manufacture or import medicinal products.

5.12 Does local authority allow the destruction of clinical supplies at an off-site location (e.g. third-party vendor in or outside the country) after study completion? Are certificates of destruction required?

We have not been able to determine an answer to this question.