Regulations

Regulations

Regulations concerning the rules of conducting clinical trial at Dolnośląskie Centrum Chorób Serca im. prof. Zbigniewa Religii Medinet Sp. z o.o.

• I. Definitions and general rules of conducting a clinical trial.

  1. Definitions related to the conduct of a clinical trial:
     1. Clinical trial - any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy (based on the Pharmaceutical Law, consolidated text, Journal of Laws of 2021, item 974 with later amendments),
     2. Investigator - a physician or a dentist, if the clinical trial concerns dentistry, or a veterinarian - in the case of a veterinary clinical trial, possessing the right to practice in the territory of the Republic of Poland and appropriately high professional qualifications, scientific knowledge and experience in work with patients, necessary for the conducted clinical trial or veterinary clinical trial, responsible for conducting those trials at a given site; if the clinical trial or veterinary clinical trial is conducted by a team of persons, the investigator appointed by the sponsor, with the consent of the head of the health care facility where the clinical trial is conducted, is the team leader responsible for conducting the trial at a given site (pursuant to the Pharmaceutical Law, consolidated text, Journal of Laws of 2021, item 974 with later amendments),
     3. Sponsor - a natural person, legal person or organisational unit without legal personality, responsible for initiating, conducting and financing the clinical trial, which is based in the territory of one of the European Union Member States or member states of the European Free Trade Association (EFTA) - a party to the Agreement on the European Economic Area, if the sponsor is not based in the territory of one of the European Economic Area countries, it may act only through its legal representative based in that territory (based on the Pharmaceutical Law, consolidated text, Journal of Laws of 2021, item 974 with later amendments),
     4. Investigational Medicinal Product - a pharmaceutical form ofan active substance or placebo being tested or used as a reference in a clinical trial,including products already with a marketing authorization but used or assembled in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about theauthorised form (pursuant to the Pharmaceutical Law, consolidated text, Journal of Laws of 2021, item 974 with later amendments),
     5. Adverse reaction of an investigational medicinal product or an investigational veterinary medicinal product - all untoward and unintended responses to an investigational medicinal product related to any dose administered (pursuant to the Pharmaceutical Law, consolidated text, Journal of Laws of 2021, item 974 with later amendments),
     6. Adverse reaction of a medicinal product - all untoward and unintended responses to a medicinal product occurring during the use of doses recommended in humans for prophylactic, diagnostic, therapeutic purposes or for modification of physiological functions (pursuant to the Pharmaceutical Law, consolidated text, Journal of Laws of 2021, item 974 with later amendments),
     7. Serious adverse event following the use of an investigational medicinal product or a veterinary investigational medicinal product - any event that at any dose of the investigational medicinal product or veterinary investigational medicinal product used results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect (pursuant to the Pharmaceutical Law, consolidated text, Journal of Laws of 2021, item 974 with later amendments),
     8. Serious adverse reaction of a medicinal product - an effect that at any dose of the medicinal product used results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity or other effect of the medicinal product, which the doctor to the best of their knowledge determines to be serious, or is a disease, a congenital anomaly or birth defect (pursuant to the Pharmaceutical Law, consolidated text, Journal of Laws of 2021, item 974 with later amendments),
     9. Good Clinical Practice (GCP) - a set of internationally recognised requirements concerning the ethics and quality of scientific research, when conducting clinical trials that guarantee the protection of rights, safety, well-being of participants in these trials and the reliability of their results (based on the Regulation of the Minister of Health of 2 May 2012 on detailed requirements of Good Clinical Practice, Journal of Laws of 2012, item 489),
     10. Clinical Research Organization (CRO) – this is a person or an organisational unit to which the Sponsor commissions certain duties or tasks related to the clinical trial (based on the Regulation of the Minister of Health of 2 May 2012 on detailed requirements of Good Clinical Practice, Journal of Laws of 2012, item 489),
     11. Clinical Trial Protocol - Protocol referred to in Chapter 4 § 17 of the Regulation of the Minister of Health of 2 May 2012 on detailed requirements of Good Clinical Practice, Journal of Laws of 2012, item 489),
     12. Investigator’s brochure – document referred to in Chapter 5 § 18 of the Regulation of the Minister of Health of 2 May 2012 on detailed requirements of Good Clinical Practice, Journal of Laws of 2012, item 489),
     13. Documentation- Documentation of the conducted trial is divided into three types:
         • Source documentation, which consists of – individual documentation and summary documentation (based on the Regulation of the Minister of Health of 9 November 2015 on types, scope and models of medical documentation and the manner of its processing, Journal of Laws of 2015, item 2069),
         • Trial documentation - which consists of the trial protocol, trial brochure, Patient Informed Consent forms, financial contracts, insurance policy, Sponsor’s National Court Register, Clinical Observation Cards, approvals and opinions of the Bioethics Committee and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, CVs and other documentation confirming the qualifications of the members of the research team, reference ranges and laboratory certificates, documentation concerning the investigational product (certificates, instructions for handling, forms for billing the investigational product)
         • Administrative and financial documentation.
  2. Clinical trials are conducted in accordance with the requirements of Good Clinical Practice, provisions of the Pharmaceutical Law and other provisions of the Polish and international law in force in this area.
  3. A clinical trial is conducted with the patient’s best interests being paramount to the interests of science, while maintaining full freedom of the patient in making decisions on participation in the clinical trial and ensuring physical and mental integrity, privacy and protection of the patient’s personal data.
  4. Conducting a clinical trial by the Investigator may not in any way limit or disorganise the provision of health services to patients of Dolnośląskie Centrum Chorób Serca im. prof. Religii MEDINET sp. z o. o. (hereinafter referred to as MEDINET or the Centre) as part of its normal statutory activity and concluded agreements on financing health services from public funds.

• II. Clinical trial design

  A. Feasibility

  1. Cooperation with Dolnośląskie Centrum Chorób Serca im. prof. Religii MEDINET sp. z o. o. (hereinafter referred to as MEDINET) begins at the stage of submitting an offer for conducting a clinical trial by an entity interested in conducting it on the premises of MEDINET.
  2. Proposals should be sent to the Clinical Research Centre at the following e-mail address: badaniakliniczne@medinet.pl
  3. Managing Director of Dolnośląskie Centrum Chorób Serca im. prof. Religii MEDINET sp. z o. o. signs the Confidentiality Agreement on behalf of MEDINET. This agreement should be filled in on a model document prepared by MEDINET or submitted in Polish or in English and Polish.
  4. Each proposed trial shall be reviewed by the Clinical Trial Assessment Panel. In the case of a positive opinion regarding the substantive value of the project, the Clinical Trial Centre sends back the completed feasibility questionnaire.

  
  

  B. Site validation

  1. In order to arrange a validation visit at a site, please contact the Clinical Trial Centre Coordinator by sending an e-mail to: badaniakliniczne@medinet.pl

  
  

  C. Trial implementation and agreement signing

  1. The basis for conducting clinical trials in MEDINET is the conclusion of a tripartite agreement between the subject requesting the trial (Sponsor, CRO), the Investigator and Dolnośląskie Centrum Chorób Serca im. Religii MEDINET sp. z o. o.
  2. A subject interested in concluding a clinical trial agreement with MEDINET should submit to the Executive Director an Application for conducting a clinical trial with all required attachments (including a draft agreement) – (Appendix 1) The application should include the following documents
     1. Draft or filled-in agreement (in accordance with the model agreement for conducting a clinical trial in MEDINET) with filled-in appendices
     2. A commitment to submit the Central Bioethics Committee’s approval to conduct the trial within three working days of its receipt
     3. Commitment to provide a clinical trial approval issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products within three working days of its receipt
     4. The trial protocol, a summary of the protocol in Polish, and the trial procedure outline,
     5. Clinical trial insurance policy that meets the requirements of the Regulation of the Minister of Finance of 6 October 2010 concerning the mandatory civil liability insurance of the sponsor and the clinical investigator in connection with the conduct of a clinical trial of devices, Journal of Laws of 2010, no 194, item 1290 with later amendments),
     6. A current excerpt from the National Court Register or a certificate of entry into the register of business activity not older than 6 months, Power of attorney for persons representing the ordering party - in case of an application submitted by persons not listed in the National Court Register,
  3. Consent of the Managing Director expressed on the basis of the above application authorises the company to request for necessary documents and certificates of the Centre and constitutes the basis for commencement of negotiations on the terms and conditions of the agreement for conducting the clinical trial.
  4. In order to commence negotiations, the interested entity sends the documents listed in item 2 in electronic form to the following e-mail address: badaniakliniczne@medinet.pl
  5. Failure to complete the documents referred to above will result in MEDINET calling for supplementation. Failure to complete the documents will be treated as a formal deficiency, which will make it impossible to start negotiations, and thus to sign the agreement.
  6. After the Managing Director gives his/her preliminary approval (Appendix 2) for the proposal to conduct a clinical trial, the Clinical Trial Coordinator transfers this information by e-mail to the members of the Clinical Trial Assessment Team (hereinafter the Team).
  7. The Managing Director issues the final decision on conducting a clinical trial in MEDINET after receiving the opinion of the Clinical Trial Assessment Team.
  8. If the Managing Director issues a positive decision, the process of negotiating the agreement for conducting a clinical trial begins:
     1. Agreeing on legal provisions, in which MEDINET’s Legal Advisor is involved
     2. Agreeing on the budget - this process involves the Clinical Trial Centre Coordinator, the Financial Specialist, and the Investigator.
  9. The agreement conclusion procedure shall be conducted in writing in the Polish language.
  10. After negotiations are completed, the ordering party sends an agreed number of copies of the negotiated agreement to MEDINET, at least 5.
  11. The Organisational Department shall register the agreement in a relevant register, giving it an internal number.
  12. All copies of original documents shall be certified as true copies by persons authorised to represent the Sponsor.
  13. Within 15 days of receipt of the above-mentioned copies of the agreement, it is accepted and initialled by the Legal Counsel and then submitted to the Managing Director for signature.
  14. The signed agreements shall be sent back by courier to the interested entity at its expense.
  15. After submitting the Clinical Trial Application, the Sponsor is obliged to pay a one-off handling fee for administrative, legal and office activities to the account of the Centre in the amount of at least PLN 5000 (net). The fee will be paid within 30 days from the date of processing the application to conduct the clinical trial at the site.
  16. The Managing Director will appoint a trial coordinator who will be the first point of contact for the company commissioning the trial for the entire duration of the trial.
  17. After receiving approval from the Central Bioethics Committee to conduct the trial and permission to conduct a clinical trial issued by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, the subject sends a scan of the approval to the Clinical Trial Centre at: badaniakliniczne@medinet.pl
  18. In the case of trials requiring other consents than those mentioned above, the Subject, after obtaining them, sends a scan of the Consent to the Clinical Trial Centre at the following address: badaniakliniczne@medinet.pl
  19. It is possible to annex the contractual provisions at the request of any of the parties - in accordance with the provisions of the negotiated tripartite agreement - then the process of signing the annexes to agreements follows in the same manner as signing the agreement.

• III. Execution of the clinical trial

  1. Preparation for the execution of a clinical trial begins with the opening of the site during the trial initiation visit.
  2. The Clinical Trial Centre Coordinator is responsible for the proper execution of the clinical trial agreement on the part of the Centre.
  3. The remuneration for the Centre for conducting clinical trial is 40% of the budget allocated for the trial (after deduction of costs of diagnostic tests, laboratory tests and costs related to hospitalisation of a patient as required by the Trial Protocol).
  4. The handling fee ( start-up fee ) for the examination of an application is obligatory, independent of the final signing of the agreement and is not refundable. The fee constitutes compensation for costs related to the examination of an application for execution of a clinical trial.
  5. The archiving fee, i.e. the fee for storage and archiving of documentation is a minimum of PLN………………….. net and is not reimbursable.
  6. The obligations of the Investigator and Sponsor are regulated by legal regulations, in particular the Regulation of the Minister of Health of 2 May 2012 on detailed requirements for Good Clinical Practice (Journal of Laws of 2012, item 489).
  7. The investigator is responsible for the substantive execution of the trial under the clinical trial agreement, as well as for maintaining and storing documentation, including medical documentation, in accordance with applicable regulations, provisions of the concluded agreement and in a way that ensures personal data protection.
  8. Recruitment of trial participants shall take place under the supervision of the Investigator. The investigator shall inform trial participants of their rights as clinical trial participants, in particular:
     1. The right to full and comprehensible information about the trial, the possible consequences of participation and to give informed written consent to participate,
     2. The right to withdraw that consent at any stage of participation in the trial without any detriment to health and without the need to justify it,
     3. The right to reimbursement of travel expenses incurred in connection with participation in the trial (patients are not entitled to any gratification in connection with participation in the trial).
  9. The investigator is required to obtain written consent from the participants to participate in the trial.
  10. The pharmacist shall be responsible for the correct maintenance and recording of free doses of medicinal products intended for the clinical trial.
  11. The investigational product intended for the clinical trial, together with documentation on storage description, batch number and quantity, shall be delivered to the Pharmacy Department by the Sponsor, where it shall be recorded, stored and prepared in accordance with the provisions of the Pharmaceutical Law and the Trial Protocol.

• VI. Reporting and accounting for the clinical trial

  1. The Accounting Department undertakes to keep separate records for a given clinical trial in a manner accessible by the financial and accounting system, i.e. each clinical trial has its own separate Cost Centre. The Accounting Department shall not be able to keep separate records of a clinical trial per patient.
  2. The investigator is obliged to correctly identify patient visits and hospitalisations in connection with the clinical trial, to mark test orders in patients included in the clinical trial and drug orders.
  3. In accordance with Article 37k 1d. of the Pharmaceutical Law, the trial coordinator / Investigator shall inform the relevant provincial branch of the National Health Fund about the PESEL [Polish Resident ID No.] number of the clinical trial participant, and in the case of its absence - about the number of the document confirming his/her identity, within 14 days from the date of inclusion in the trial.
  4. The investigator is obliged to identify the individual file of the patient participating in the trial.
  5. The Coordinator together with the Investigator shall be responsible for the accuracy and timeliness of the data provided.

• V. Retention of records

  1. For the duration of the trial, the trial records shall be kept in the Clinical Trial Centre in complete security.
  2. The Coordinator keeps all documents related to the clinical trial agreement
  3. Source documentation of patients during the clinical trial may be located:
     • in the Outpatient Clinic, which is the Clinical Trial Site,
     • in the Department, which is the Research Centre,
     • Clinical Trial Centre.
  4. After completion of the clinical trial, the trial documentation is transferred by the Trial Coordinator upon request of the Principal Investigator to the hospital archives. The period for which the documentation is retained is specified in the clinical trial agreement or legal regulations in this respect.

• VI. Completion of the trial

  1. The Sponsor shall notify the Investigator of the end of the trial.
  2. Immediately after completion of the trial, the Investigator shall submit to the Coordinator information about the end of the clinical trial and shall submit, through the Coordinator, to the Managing Director the final settlement agreed by the Trial Coordinator with the Financial Director - in accordance with Appendix No. 6. The Clinical Trial Site Coordinator attaches information about the possibility of purchasing equipment donated for the duration of the trial.
  3. Upon completion of the trial, the Pharmacy Department Manager provides a copy of the trial product records to the Clinical Trial Centre Coordinator.
  4. The site closure visit for a given trial may only take place after final settlement between the sponsor, the Institution and the Investigator with notification and presence of the Trial Team.

• VII. Summary

  1. Failure to comply with the above Clinical Trial Procedure will result in no agreement or termination of the agreement to conduct the clinical trial in question.

Legal provisions:

1. Act of 6 September 2001. Pharmaceutical Law, consolidated text, Journal of Laws of 2021, item 974 with later amendments;
2. Regulation of the Minister of Health of 2 May 2012 on detailed requirements of Good Clinical Practice, Journal of Laws of 2012, item 489;
3. Regulation of the Minister of Health of 30 April 2004 on the manner of conducting clinical trials involving minors (Journal of Laws, No. 104, item 1108;
4. Regulation of the Minister of Finance of 6 October 2010 concerning the mandatory civil liability insurance of the sponsor and the clinical investigator in connection with the conduct of a clinical trial of devices, Journal of Laws of 2010, no 194, item 1290 with later amendments.