Common use of Responsibilities of the Principal Investigator Clause in Contracts

Responsibilities of the Principal Investigator. The Principal Investigator undertakes to: conduct the Clinical Trial in accordance with the Protocol and the applicable laws; adhere to any instructions regarding the conduct of the Clinical Trial, as received from the Sponsor or set forth in the Good Clinical Practice; perform the Clinical Trial, which includes Trial Participants recruitment, performing services specified in the Protocol and the Investigator’s Brochure, providing – in cooperation with the Site – proper medical care to the Participants during the Trial, completing CRFs, and reporting on Trial progress to the Sponsor; comply with the principles of collecting, reporting and storing data as set forth in this Agreement, the Protocol, and generally applicable laws, within the timeframes and according to the requirements specified by the Sponsor; ensure the protection of data, including personal data of the Trial Participants collected as part of the Trial, and to keep such data confidential; hand over, upon each request of the Sponsor, any materials and studies collected and developed as part of performance hereunder. Upon the consent of the CRO, the Principal Investigator shall appoint a trial team among the employees and contractors of the Site, as necessary to perform the Clinical Trial, exhibiting the necessary skills and qualifications (the “Trial Team”). The Principal Investigator represents that every member of the Trial Team abide by the provisions of this Agreement and the Protocol. The Principal Investigator shall be liable for the actions or omissions of the Trial Team during the conduct of the Clinical Trial as if they were the Principal Investigator’s own actions or omissions. The Principal Investigator shall exercise direct supervision over the correct performance of the activities entrusted by him/her to selected persons and shall evaluate and accept the work once delivered. The Principal Investigator represents that he/she has the necessary qualifications and licences to act as an investigator, which shall be evidenced, upon the Sponsor’s request, by presenting the relevant documents (as required by the applicable laws). If a Serious Adverse Event (SAE) occurs, the Principal Investigator is obliged to adhere to the Sponsor’s instructions, as set out in the Protocol or in other instructions handed over by the Sponsor, and to report such an event immediately to the Site and the Sponsor within 24 hours of becoming aware thereof. In the event of receiving queries from the CRO or the Sponsor regarding adverse events, the Principal Investigator shall respond to any such questions to the best of his/her knowledge. If a serious breach of the Protocol or the provisions of EU Regulation 536/2014 occurs, the Principal Investigator is obliged to immediately report such a breach to the Site and the Sponsor within 24 hours of becoming aware thereof. In the event of receiving queries from the CRO or the Sponsor regarding said serious breaches, the Principal Investigator shall respond to any such questions to the best of his/her knowledge. The Principal Investigator is responsible for maintaining the Trial documentation in accordance with applicable laws and the Protocol, including ensuring appropriate conditions for archiving the Trial documentation, during the Trial and after its conclusion. The Principal Investigator shall perform this Agreement in person and shall not assign any rights or obligations arising herefrom without the prior written consent of the Sponsor and the Site. When conducting the Clinical Trial, the Principal Investigator shall always exercise his/her best professional judgment, in compliance with the Trial requirements, in relation to all individuals participating in the Clinical Trial. The Principal Investigator represents that no proceedings are currently pending that could lead to the Principal Investigator’s debarment or suspension of his/her medical licence. The Principal Investigator represents that as part of performance hereunder he/she shall not procure services from any person known by the Principal Investigator to have been debarred or suspended. The Principal Investigator undertakes to establish the amount of remuneration due to the members of the Trial Team on the basis of the actual workload of individual members of the Trial Team, and shall provide the CRO with a relevant list within the agreed billing periods. The CRO shall conclude appropriate cooperation agreements with the members of the Trial Team. Pursuant to art. 60 of the Polish Act on clinical trials of medicinal products for human use, the Principal Investigator/Site shall inform, in paper or electronic form, the competent provincial branch of the Polish National Health Fund about the following: name and surname of the Investigator and information on the entity providing healthcare services, the Polish Personal Identification Number (PESEL) of a Trial Participant, and in the event that this number has not been assigned – the type and number of the document confirming identity and date of birth, the date on which a Trial Participant was enrolled into the Clinical Trial, understood as the date of signing the informed consent to participate in the Trial, if applicable, as well as the date of termination of such Participant's participation in the Clinical Trial, classification of the Clinical Trial – commercial clinical trial or non-commercial clinical trial, unique EU trial number, as referred to in art. 81(1) of Regulation 536/2014.

Responsibilities of the Principal Investigator. The Principal Investigator undertakes to: conduct the Clinical Trial in accordance with the Protocol and the applicable laws; adhere to any instructions regarding the conduct of the Clinical Trial, as received from the Sponsor or set forth in the Good Clinical Practice; perform the Clinical Trial, which includes Trial Participants recruitment, performing services specified in the Protocol and the Investigator’s Brochure, providing – in cooperation with the Site Institution – proper medical care to the Participants during the Trial, completing CRFs, and reporting on Trial progress to the Sponsor; comply with the principles of collecting, reporting and storing data as set forth in this Agreement, the Protocol, and generally applicable laws, within the timeframes and according to the requirements specified by the Sponsor; ensure the protection of data, including personal data of the Trial Participants collected as part of the Trial, and to keep such data confidential; hand over, upon each request of the Sponsor, any materials and studies collected and developed as part of performance hereunder. Upon the consent of the CRO, the Principal Investigator shall appoint a trial team among the employees and contractors of the Site, as necessary to perform the Clinical Trial, exhibiting the necessary skills and qualifications (the “Trial Team”). The Principal Investigator represents that every member of the Trial Team abide by the provisions of this Agreement and the Protocol. The Principal Investigator shall be liable for the actions or omissions of the Trial Team during the conduct of the Clinical Trial as if they were the Principal Investigator’s own actions or omissions. The Principal Investigator shall exercise direct supervision over the correct performance of the activities entrusted by him/her to selected persons and shall evaluate and accept the work once delivered. The Principal Investigator represents that he/she has the necessary qualifications and licences to act as an investigator, which shall be evidenced, upon the Sponsor’s request, by presenting the relevant documents (as required by the applicable laws). If a Serious Adverse Event (SAE) occurs, the Principal Investigator is obliged to adhere to the Sponsor’s instructions, as set out in the Protocol or in other instructions handed over by the Sponsor, and to report such an event immediately to the Site Institution and the Sponsor within 24 hours of becoming aware thereof. In the event of receiving queries from the CRO or the Sponsor regarding adverse events, the Principal Investigator shall respond to any such questions to the best of his/her knowledge. If a serious breach of the Protocol or the provisions of EU Regulation 536/2014 occurs, the Principal Investigator is obliged to immediately report such a breach to the Site Institution and the Sponsor within 24 hours of becoming aware thereof. In the event of receiving queries from the CRO or the Sponsor regarding said serious breaches, the Principal Investigator shall respond to any such questions to the best of his/her knowledge. The Principal Investigator is responsible for maintaining the Trial documentation in accordance with applicable laws and the Protocol, including ensuring appropriate conditions for archiving the Trial documentation, during the Trial and after its conclusion. The Principal Investigator shall perform this Agreement in person and shall not assign any rights or obligations arising herefrom without the prior written consent of the Sponsor and the SiteInstitution. When conducting the Clinical Trial, the Principal Investigator shall always exercise his/her best professional judgment, in compliance with the Trial requirements, in relation to all individuals participating in the Clinical Trial. The Principal Investigator represents that no proceedings are currently pending that could lead to the Principal Investigator’s debarment or suspension of his/her medical licence. The Principal Investigator represents that as part of performance hereunder he/she shall not procure services from any person known by the Principal Investigator to have been debarred or suspended. The Principal Investigator undertakes to establish the amount of remuneration due to the members of the Trial Team on the basis of the actual workload of individual members of the Trial Team, and shall provide the CRO with a relevant list within the agreed billing periods. The CRO shall conclude appropriate cooperation agreements with the members of the Trial Team. Pursuant to art. 60 of the Polish Act on clinical trials of medicinal products for human use, the Principal Investigator/Site Investigator shall inform, in paper or electronic form, the competent provincial branch of the Polish National Health Fund about the following: name and surname of the Investigator and information on the entity providing healthcare services, the Polish Personal Identification Number (PESEL) of a Trial Participant, and in the event that this number has not been assigned – the type and number of the document confirming identity and date of birth, the date on which a Trial Participant was enrolled into the Clinical Trial, understood as the date of signing the informed consent to participate in the Trial, if applicable, as well as the date of termination of such Participant's participation in the Clinical Trial, classification of the Clinical Trial – commercial clinical trial or non-commercial clinical trial, unique EU trial number, as referred to in art. 81(1) of Regulation 536/2014.

Responsibilities of the Principal Investigator. The Principal Investigator undertakes to: conduct the Clinical Trial in accordance with the Protocol and the applicable laws; adhere to any instructions regarding the conduct of the Clinical Trial, as received from the Sponsor or set forth in the Good Clinical Practice; perform the Clinical Trial, which includes Trial Participants recruitment, performing services specified in the Protocol and the Investigator’s Brochure, providing – in cooperation with the Site – proper medical care to the Participants during the Trial, completing CRFs, and reporting on Trial progress to the Sponsor; comply with the principles of collecting, reporting and storing data as set forth in this Agreement, the Protocol, and generally applicable laws, within the timeframes and according to the requirements specified by the Sponsor; ensure the protection of data, including personal data of the Trial Participants collected as part of the Trial, and to keep such data confidential; hand over, upon each request of the Sponsor, any materials and studies collected and developed as part of performance hereunder. Upon the consent of the CRO, the Principal Investigator shall appoint a trial team among the employees and contractors of the Site, as necessary to perform the Clinical Trial, exhibiting the necessary skills and qualifications (the “Trial Team”). The Principal Investigator represents that every member of the Trial Team abide by the provisions of this Agreement and the Protocol. The Principal Investigator shall be liable for the actions or omissions of the Trial Team during the conduct of the Clinical Trial as if they were the Principal Investigator’s own actions or omissions. The Principal Investigator shall exercise direct supervision over the correct performance of the activities entrusted by him/her to selected persons and shall evaluate and accept the work once delivered. The Principal Investigator represents that he/she has the necessary qualifications and licences to act as an investigator, which shall be evidenced, upon the SponsorCRO’s request, by presenting the relevant documents (as required by the applicable laws). If a Serious Adverse Event (SAE) occurs, the Principal Investigator is obliged to adhere to the Sponsor’s instructions, as set out in the Protocol or in other instructions handed over by the Sponsor, and to report such an event immediately to the Site and the Sponsor within 24 hours of becoming aware thereof. In the event of receiving queries from the CRO or the Sponsor regarding adverse events, the Principal Investigator shall respond to any such questions to the best of his/her knowledge. If a serious breach of the Protocol or the provisions of EU Regulation 536/2014 occurs, the Principal Investigator is obliged to immediately report such a breach to the Site Institution, the Site, and the Sponsor within 24 hours of becoming aware thereof. In the event of receiving queries from the CRO or the Sponsor regarding said serious breaches, the Principal Investigator shall respond to any such questions to the best of his/her knowledge. The Principal Investigator is responsible for maintaining the Trial documentation in accordance with applicable laws and the Protocol, including ensuring appropriate conditions for archiving the Trial documentation, during the Trial and after its conclusion. The Principal Investigator shall perform this Agreement in person and shall not assign any rights or obligations arising herefrom without the prior written consent of the Sponsor Sponsor, the Institution, and the Site. When conducting the Clinical Trial, the Principal Investigator shall always exercise his/her best professional judgment, in compliance with the Trial requirements, in relation to all individuals participating in the Clinical Trial. The Principal Investigator represents that no proceedings are currently pending that could lead to the Principal Investigator’s debarment or suspension of his/her medical licence. The Principal Investigator represents that as part of performance hereunder he/she shall not procure services from any person known by the Principal Investigator to have been debarred or suspended. The Principal Investigator undertakes to establish the amount of remuneration due to the members of the Trial Team on the basis of the actual workload of individual members of the Trial Team, and shall provide the CRO with a relevant list within the agreed billing periods. The CRO shall conclude appropriate cooperation agreements with the members of the Trial Team. Pursuant to art. 60 of the Polish Act on clinical trials of medicinal products for human use, the Principal Investigator/Site Investigator shall inform, in paper or electronic form, the competent provincial branch of the Polish National Health Fund about the following: name and surname of the Investigator and information on the entity providing healthcare services, the Polish Personal Identification Number (PESEL) of a Trial Participant, and in the event that this number has not been assigned – the type and number of the document confirming identity and date of birth, the date on which a Trial Participant was enrolled into the Clinical Trial, understood as the date of signing the informed consent to participate in the Trial, if applicable, as well as the date of termination of such Participant's participation in the Clinical Trial, classification of the Clinical Trial – commercial clinical trial or non-commercial clinical trial, unique EU trial number, as referred to in art. 81(1) of Regulation 536/2014.