Subject of the Agreement. 2.1 The Sponsor/CRO hereby entrusts the Entity with the execution of the Trial under the terms of this Agreement, in accordance with the Protocol and any subsequent amendments, and with the amendments to this Agreement/budget resulting from such amendments formalised by the necessary deeds of amendment, duly signed. 2.2 The Trial is to be conducted in strict compliance with the Protocol, in the version in force as accepted by the Principal Investigator and approved by the Ethics Committee and the Competent Authority in conformity with the laws applicable to clinical drugs trials and the principles of ethics and medical practice followed by the healthcare staff involved in the Trial in any capacity. 2.3 The Trial shall also be conducted in accordance with the principles of the Convention on Human Rights and Biomedicine, the updated version of the Helsinki Declaration, the current rules of good clinical practice, and in accordance with the applicable laws on transparency, anti-corruption and the current data protection regulations. 2.4 By signing this Agreement, the Parties declare that they know and accept the contents of the above rules and regulations. 2.5 The Sponsor and the Principal Investigator have an obligation to protect patients’ safety and, where required in the circumstances, may take urgent, appropriate measures to protect patients’ safety such as temporarily suspending the Study (interruption of treatment for patients already enrolled or interruption of the enrolment of new patients), even without the necessary approval of the Ethics Committee and the Competent Authority, subject to the Sponsor's obligation to inform the Ethics Committee and the Competent Authority immediately of any new events, the measures taken, and the programme of measures to be taken in the future, and will duly complete the procedures required by the applicable laws. (a) In the case of non-competitive inclusion of patients or (b) In the case of a multi-centre competitive-enrolment trial 2.7 The Entity and the Sponsor will keep the Trial documentation (the “Trial Master File”) for the period of time specified in the applicable laws. The Entity agrees, as of the date of this Agreement, to keep the documentation for a period of seven years (or for a longer period if required by other applicable laws or by a financial agreement between Entity and the Sponsor). The Sponsor is obligated to inform the Centre of the expiry of the mandatory conservation period (only if requested). At the request of the Sponsor, after expiry of the mandatory conservation period, the Parties may agree the terms of a further conservation period. 2.8 The Entity and the Sponsor, each within their own sphere of responsibility, shall also use forms of digitalisation (or dematerialisation) to conserve the documentation. Regardless of whether or not the archived Trial documentation contains personal data (of a special nature or otherwise), according to the definitions in Regulation (EU) No. 679/2016, the Entity and the Sponsor shall take all the physical and technical measures referred to in Article 32 of said Regulation (EU) No. 679/2016 and shall carry out any security checks as required by ISO 27001 as amended to protect the data, information and documents (both printed and digital). The archiving system shall guarantee not only the integrity of the data, information and printed/digital documents but also their future legibility throughout the mandatory conservation period. To fulfil such obligation both the Sponsor and the Entity may rely on external service providers to manage the archiving obligation. 2.9 The Sponsor, the Entity and the Principal Investigator shall comply with the directions, indications, instructions and recommendations given by the Ethics Committee and by the Competent Authority.
Appears in 5 contracts
Samples: Clinical Investigation Agreement, Clinical Investigation Agreement, Clinical Investigation Agreement
Subject of the Agreement. 2.1 The Sponsor/CRO hereby entrusts the Entity with the execution of the Trial Clinical investigation under the terms of this Agreement, in accordance with the Protocol and any subsequent amendments, and with the amendments to this Agreement/budget resulting from such amendments formalised by the necessary deeds of amendment, duly signed.
2.2 The Trial Clinical investigation is to be conducted in strict compliance with the Protocol, in the version in force as accepted by the Principal Investigator and approved by the Ethics Committee and the Competent Authority Authority, in conformity with the laws applicable to clinical drugs trials Clinical investigations on medical devices and the principles of ethics and medical practice followed by the healthcare staff involved in the Trial investigation in any capacity.
2.3 The Trial Clinical investigation shall also be conducted in accordance with the principles of the Convention on Human Rights and Biomedicine, the updated version of the Helsinki Declaration, the current rules of good clinical practice, and in accordance with the applicable laws on transparency, anti-corruption and the current data protection regulations.
2.4 By signing this Agreement, the Parties declare that they know and accept the contents of the above rules and regulations.
2.5 The Sponsor and the Principal Investigator have an obligation to protect patients’ safety and, where required in the circumstances, may take urgent, appropriate measures to protect patients’ safety such as temporarily suspending the Study trial (interruption of treatment for patients already enrolled in the Clinical investigation or interruption of the enrolment of new patients), even without the necessary approval of the Ethics Committee and and, if applicable, the Competent Authority, subject to the Sponsor's obligation to inform the Ethics Committee and the Competent Authority immediately of any new events, the measures taken, and the programme of measures to be taken in the future, and will duly complete the procedures required by the applicable laws.
(a) In the case of non-competitive inclusion of patients or
(b) In the case of a multi-centre competitive-enrolment trial
2.7 The Entity and the Sponsor will keep the Trial documentation (the “Trial Master File”) for the period of time specified in the applicable laws. The Entity agrees, as of the date of this Agreement, to keep the documentation for a period of seven years (or for a longer period if required by other applicable laws or by a financial agreement between Entity and the Sponsor). The Sponsor is obligated to inform the Centre of the expiry of the mandatory conservation period (only if requested). At the request of the Sponsor, after expiry of the mandatory conservation period, the Parties may agree the terms of a further conservation period.
2.8 The Entity and the Sponsor, each within their own sphere of responsibility, shall also use forms of digitalisation (or dematerialisation) to conserve the documentation. Regardless of whether or not the archived Trial documentation contains personal data (of a special nature or otherwise), according to the definitions in Regulation (EU) No. 679/2016, the Entity and the Sponsor shall take all the physical and technical measures referred to in Article 32 of said Regulation (EU) No. 679/2016 and shall carry out any security checks as required by ISO 27001 as amended to protect the data, information and documents (both printed and digital). The archiving system shall guarantee not only the integrity of the data, information and printed/digital documents but also their future legibility throughout the mandatory conservation period. To fulfil such obligation both the Sponsor and the Entity may rely on external service providers to manage the archiving obligation.
2.9 The Sponsor, the Entity and the Principal Investigator shall comply with the directions, indications, instructions and recommendations given by the Ethics Committee and by the Competent Authority.patients
Appears in 4 contracts
Samples: Clinical Investigation Agreement, Clinical Investigation Agreement, Clinical Investigation Agreement
Subject of the Agreement. 2.1 The Sponsor/CRO hereby entrusts the Entity with the execution of the Trial under the terms of this Agreement, in accordance with the Protocol and any subsequent amendments, and with the amendments to this Agreement/budget resulting from such amendments formalised by the necessary deeds of amendment, duly signed.
2.2 The Trial is to be conducted in strict compliance with the Protocol, in the version in force as accepted by the Principal Investigator and approved by the Ethics Committee and the Competent Authority in conformity with the laws applicable to clinical drugs trials and the principles of ethics and medical practice followed by the healthcare staff involved in the Trial in any capacity.
2.3 The Trial shall also be conducted in accordance with the principles of the Convention on Human Rights and Biomedicine, the updated version of the Helsinki Declaration, the 2008 Istanbul Declaration, the current rules of good clinical practice, and in accordance with the applicable laws on transparency, anti-corruption and the current data protection regulations.
2.4 By signing this Agreement, the Parties declare that they know and accept the contents of the above rules and regulations.
2.5 The Sponsor and the Principal Investigator have an obligation to protect patients’ safety and, where required in the circumstances, may take urgent, appropriate measures to protect patients’ safety such as temporarily suspending the Study (interruption of treatment for patients already enrolled or interruption of the enrolment of new patients), even without the necessary approval of the Ethics Committee and the Competent Authority, subject to the Sponsor's obligation to inform the Ethics Committee and the Competent Authority immediately of any new events, the measures taken, and the programme of measures to be taken in the future, and will duly complete the procedures required by the applicable laws.
(a) In the case of non-competitive inclusion of patients or
(b) In the case of a multi-centre competitive-enrolment trial
2.7 The Entity and the Sponsor will keep the Trial documentation (the “Trial Master File”) for the period of time specified in the applicable laws. The Entity agrees, as of the date of this Agreement, to keep the documentation for a period of seven years (or for a longer period if required by other applicable laws or by a financial agreement between Entity and the Sponsor). The Sponsor is obligated to inform the Centre of the expiry of the mandatory conservation period (only if requested). At the request of the Sponsor, after expiry of the mandatory conservation period, the Parties may agree the terms of a further conservation period.
2.8 The Entity and the Sponsor, each within their own sphere of responsibility, shall also use forms of digitalisation (or dematerialisation) to conserve the documentation. Regardless of whether or not the archived Trial documentation contains personal data (of a special nature or otherwise), according to the definitions in Regulation (EU) No. 679/2016, the Entity and the Sponsor shall take all the physical and technical measures referred to in Article 32 of said Regulation (EU) No. 679/2016 and shall carry out any security checks as required by ISO 27001 27011 as amended to protect the data, information and documents (both printed and digital). The archiving system shall guarantee not only the integrity of the data, information and printed/digital documents but also their future legibility throughout the mandatory conservation period. To fulfil such obligation both the Sponsor and the Entity may rely on external service providers to manage the archiving obligation.
2.9 The Sponsor, the Entity and the Principal Investigator shall comply with the directions, indications, instructions and recommendations given by the Ethics Committee and by the Competent Authority.
3.1 The Principal Investigator shall be supported in the execution of the Trial by the healthcare and non-healthcare personnel and by any contractors engaged by the Entity, as appointed by the Entity and operating under its responsibility for all aspects pertaining to this Trial, who are qualified to conduct the Trial, and who have previously received adequate training as provided for in the applicable laws, by the Sponsor/CRO and who have declared their willingness to take part in the Trial (the Co-investigators). Without affecting the foregoing, the definition of “Investigators” does not include any medical or non-medical personnel who perform proprietary institutional activities in the context of the Trial (for example hospital pharmacists who prepare the trial drugs).
3.2 The Parties acknowledge that the Principal Investigator is bound by all the responsibilities and obligations imposed on their role by the applicable regulations on clinical drug trials.
3.3 This Agreement is made between the Sponsor/CRO and the Entity. The Sponsor/CRO is extraneous to the relations between the Entity, the Principal Investigator and the Co-investigators, and is thus indemnified in respect of any claim that the personnel of the Entity involved in the study may make in relation to the Trial.
3.4 In relation to the Trial, the Principal Investigator and the Co-investigators may not receive any direct or indirect compensation from the Sponsor/CRO, nor have any contact or dealings with the Sponsor/CRO or relations of any kind that are not of a technical or scientific nature.
3.5 If the relationship between the Principal Investigator and the Entity ends for any reason, the Entity will inform the Sponsor/CRO in writing and indicate the name of a replacement. The named replacement must be approved by the Sponsor/CRO and by the competent Ethics Committee. The Entity guarantees that the new Principal Investigator is qualified to continue the Trial, that they will accept the terms and conditions of this Agreement and that they will agree to respect the Protocol when executing the Trial. Pending approval of the substantial amendment for the change of Principal Investigator, the investigator indicated by the Sponsor shall carry out the necessary trial activities. If the Sponsor/CRO does not intend to accept the name of the replacement proposed by the Entity, or if the Entity does not propose a substitute, the Sponsor/CRO may terminate this Agreement in accordance with the provisions of Article 7.
3.6 Before starting the Trial, the Principal Investigator shall obtain the informed consent of the patient or his/her legal representative in accordance with the current laws on clinical trials, and also in accordance with Regulation (EU) 2016/679 and the Italian enacting laws (legislative decree 196 of 30 June 2003 as amended by legislative decree 101 of 10 August 2018). Consent shall also be provided for the processing of personal data in accordance with the current Italian and EC laws on data protection as amended, and as outlined in Article 11 below.
3.7 The Principal Investigator shall provide information to the Sponsor/CRO and to the Ethics Committee in relation to the progress of the Trial and shall promptly inform the Sponsor/CRO of any serious adverse events, subject to any other obligations to report to the Ethics Committee in accordance with current regulations, plus any other clinical information that is relevant to the study and indicated in the Protocol (e.g: pregnancy) that is directly or indirectly related to the execution of the Trial, in accordance with the provisions of the Protocol, the rules of Good Clinical Practice and the laws applicable to pharmacovigilance and clinical drugs trials.
3.8 The Entity guarantees that the Principal Investigator shall undertake to execute the Trial in accordance with the highest standards of diligence.
3.8.1 The Principal Investigator shall keep all of the Case Report Forms (CRF), duly compiled, in accordance with the terms and conditions of the Protocol for the trial and with the applicable regulations, in printed or digital form and in any case they shall be delivered promptly in accordance with the GCP, by the date indicated in the trial Protocol.
3.8.2 The Principal Investigator shall also resolve any queries raised by the Sponsor/CRO by the date indicated in the trial Protocol.
3.8.3 To verify the correspondence between the data recorded on the CRF and the data contained in the original clinical records, the Entity and the Principal Investigator shall allow direct access to the source data during the monitoring visits and any audits by the Sponsor/CRO and inspections by the Competent Authorities, including remote methods, provided that the laws on confidentiality and patient privacy are respected.
3.8.4 The Entity and the Principal Investigator, having been informed sufficiently in advance, shall allow the correct execution of the monitoring and auditing at the Trial Centre ______ by the Sponsor/CRO and by the Competent Authority, such activities to be carried out to guarantee the proper execution of the Trial.
Appears in 3 contracts
Samples: Clinical Investigation Agreement, Clinical Investigation Agreement, Clinical Investigation Agreement
Subject of the Agreement. 2.1 The Sponsor/CRO hereby entrusts the Entity with the execution of the Trial under the terms of this Agreement, in accordance with the Protocol and any subsequent amendments, and with the amendments to this Agreement/budget resulting from such amendments formalised by the necessary deeds of amendment, duly signed.
2.2 The Trial is to be conducted in strict compliance with the Protocol, in the version in force as accepted by the Principal Investigator and approved by the Ethics Committee and the Competent Authority in conformity with the laws applicable to clinical drugs trials and the principles of ethics and medical practice followed by the healthcare staff involved in the Trial in any capacity.
2.3 The Trial shall also be conducted in accordance with the principles of the Convention on Human Rights and Biomedicine, the updated version of the Helsinki Declaration, the current rules of good clinical practice, and in accordance with the applicable laws on transparency, anti-corruption and the current data protection regulations.
2.4 By signing this Agreement, the Parties declare that they know and accept the contents of the above rules and regulations.
2.5 The Sponsor and the Principal Investigator have an obligation to protect patients’ safety and, where required in the circumstances, may take urgent, appropriate measures to protect patients’ safety such as temporarily suspending the Study (interruption of treatment for patients already enrolled or interruption of the enrolment of new patients), even without the necessary approval of the Ethics Committee and the Competent Authority, subject to the Sponsor's obligation to inform the Ethics Committee and the Competent Authority immediately of any new events, the measures taken, and the programme of measures to be taken in the future, and will duly complete the procedures required by the applicable laws.
(a) In the case of non-competitive inclusion of patients or
(b) In the case of a multi-centre competitive-enrolment trial
2.7 The Entity and the Sponsor will keep the Trial documentation (the “Trial Master File”) for the period of time specified in the applicable laws. The Entity agrees, as of the date of this Agreement, to keep the documentation for a period of seven years (or for a longer period if required by other applicable laws or by a financial agreement between Entity and the Sponsor). The Sponsor is obligated to inform the Centre of the expiry of the mandatory conservation period (only if requested). At the request of the Sponsor, after expiry of the mandatory conservation period, the Parties may agree the terms of a further conservation period.
2.8 The Entity and the Sponsor, each within their own sphere of responsibility, shall also use forms of digitalisation (or dematerialisation) to conserve the documentation. Regardless of whether or not the archived Trial documentation contains personal data (of a special nature or otherwise), according to the definitions in Regulation (EU) No. 679/2016, the Entity and the Sponsor shall take all the physical and technical measures referred to in Article 32 of said Regulation (EU) No. 679/2016 and shall carry out any security checks as required by ISO 27001 as amended to protect the data, information and documents (both printed and digital). The archiving system shall guarantee not only the integrity of the data, information and printed/digital documents but also their future legibility throughout the mandatory conservation period. To fulfil such obligation both the Sponsor and the Entity may rely on external service providers to manage the archiving obligation.
2.9 The Sponsor, the Entity and the Principal Investigator shall comply with the directions, indications, instructions and recommendations given by the Ethics Committee and by the Competent Authority.
3.1 The Principal Investigator shall be supported in the execution of the Trial by the healthcare and non-healthcare personnel and by any contractors engaged by the Entity, as appointed by the Entity and operating under its responsibility for all aspects pertaining to this Trial, who are qualified to conduct the Trial, and who have previously received adequate training as provided for in the applicable laws, by the Sponsor/CRO and who have declared their willingness to take part in the Trial (the Co-investigators). Without affecting the foregoing, the definition of “Investigators” does not include any medical or non-medical personnel who perform proprietary institutional activities in the context of the Trial (for example hospital pharmacists who prepare the trial drugs).
3.2 The Parties acknowledge that the Principal Investigator is bound by all the responsibilities and obligations imposed on their role by the applicable regulations on clinical drug trials.
3.3 This Agreement is made between the Sponsor/CRO and the Entity. The Sponsor/CRO is extraneous to the relations between the Entity, the Principal Investigator and the Co-investigators, and is thus indemnified in respect of any claim that the personnel of the Entity involved in the study may make in relation to the Trial.
3.4 In relation to the Trial, the Principal Investigator and the Co-investigators may not receive any direct or indirect compensation from the Sponsor/CRO, nor have any contact or dealings with the Sponsor/CRO or relations of any kind that are not of a technical or scientific nature.
3.5 If the relationship between the Principal Investigator and the Entity ends for any reason, the Entity will inform the Sponsor/CRO in writing and indicate the name of a replacement. The named replacement must be approved by the Sponsor/CRO and by the competent Ethics Committee. The Entity guarantees that the new Principal Investigator is qualified to continue the Trial, that they will accept the terms and conditions of this Agreement and that they will agree to respect the Protocol when executing the Trial. Pending approval of the substantial amendment for the change of Principal Investigator, the investigator indicated by the Sponsor shall carry out the necessary trial activities. If the Sponsor/CRO does not intend to accept the name of the replacement proposed by the Entity, or if the Entity does not propose a substitute, the Sponsor/CRO may terminate this Agreement in accordance with the provisions of Article 7.
3.6 Before starting the Trial, the Principal Investigator shall obtain the informed consent of the patient or his/her legal representative in accordance with the current laws on clinical trials, and also in accordance with Regulation (EU) 2016/679 and the Italian enacting laws (legislative decree 196 of 30 June 2003 as amended by legislative decree 101 of 10 August 2018). Consent shall also be provided for the processing of personal data in accordance with the current Italian and EC laws on data protection as amended, and as outlined in Article 11 below.
3.7 The Principal Investigator shall provide information to the Sponsor/CRO and to the Ethics Committee in relation to the progress of the Trial and shall promptly inform the Sponsor/CRO of any serious adverse events, subject to any other obligations to report to the Ethics Committee in accordance with current regulations, plus any other clinical information that is relevant to the study and indicated in the Protocol (e.g: pregnancy) that is directly or indirectly related to the execution of the Trial, in accordance with the provisions of the Protocol, the rules of Good Clinical Practice and the laws applicable to pharmacovigilance and clinical drugs trials.
3.8 The Entity guarantees that the Principal Investigator shall undertake to execute the Trial in accordance with the highest standards of diligence.
3.8.1 The Principal Investigator shall keep all of the Case Report Forms (CRF), duly compiled, in accordance with the terms and conditions of the Protocol for the trial and with the applicable regulations, in printed or digital form and in any case they shall be delivered promptly in accordance with the GCP, by the date indicated in the trial Protocol.
3.8.2 The Principal Investigator shall also resolve any queries raised by the Sponsor/CRO by the date indicated in the trial Protocol.
3.8.3 To verify the correspondence between the data recorded on the CRF and the data contained in the original clinical records, the Entity and the Principal Investigator shall allow direct access to the source data during the monitoring visits and any audits by the Sponsor/CRO and inspections by the Competent Authorities, including remote methods, provided that the laws on confidentiality and patient privacy are respected.
3.8.4 The Entity and the Principal Investigator, having been informed sufficiently in advance, shall allow the correct execution of the monitoring and auditing at the Trial Centre ______ by the Sponsor/CRO and by the Competent Authority, such activities to be carried out to guarantee the proper execution of the Trial.
Appears in 2 contracts
Samples: Clinical Investigation Agreement, Clinical Investigation / Study Agreement
Subject of the Agreement. 2.1 The Sponsor/CRO hereby entrusts the Entity with the execution of the Trial under the terms of this Agreement, in accordance with the Protocol and any subsequent amendments, and with the amendments to this Agreement/budget resulting from such amendments formalised by the necessary deeds of amendment, duly signed.
2.2 The Trial is to be conducted in strict compliance with the Protocol, in the version in force as accepted by the Principal Investigator and approved by the Ethics Committee and the Competent Authority in conformity with the laws applicable to clinical drugs trials and the principles of ethics and medical practice followed by the healthcare staff involved in the Trial in any capacity.
2.3 The Trial shall also be conducted in accordance with the principles of the Convention on Human Rights and Biomedicine, the updated version of the Helsinki Declaration, the 2008 Istanbul Declaration, the current rules of good clinical practice, and in accordance with the applicable laws on transparency, anti-corruption and the current data protection regulations.
2.4 By signing this Agreement, the Parties declare that they know and accept the contents of the above rules and regulations.
2.5 The Sponsor and the Principal Investigator have an obligation to protect patients’ safety and, where required in the circumstances, may take urgent, appropriate measures to protect patients’ safety such as temporarily suspending the Study (interruption of treatment for patients already enrolled or interruption of the enrolment of new patients), even without the necessary approval of the Ethics Committee and the Competent Authority, subject to the Sponsor's obligation to inform the Ethics Committee and the Competent Authority immediately of any new events, the measures taken, and the programme of measures to be taken in the future, and will duly complete the procedures required by the applicable laws.
(a) In the case of non-competitive inclusion of patients or
(b) In the case of a multi-centre competitive-enrolment trial
2.7 The Entity and the Sponsor will keep the Trial documentation (the “Trial Master File”) for the period of time specified in the applicable laws. The Entity agrees, as of the date of this Agreement, to keep the documentation for a period of seven years (or for a longer period if required by other applicable laws or by a financial agreement between Entity and the Sponsor). The Sponsor is obligated to inform the Centre of the expiry of the mandatory conservation period (only if requested). At the request of the Sponsor, after expiry of the mandatory conservation period, the Parties may agree the terms of a further conservation period.
2.8 The Entity and the Sponsor, each within their own sphere of responsibility, shall also use forms of digitalisation (or dematerialisation) to conserve the documentation. Regardless of whether or not the archived Trial documentation contains personal data (of a special nature or otherwise), according to the definitions in Regulation (EU) No. 679/2016, the Entity and the Sponsor shall take all the physical and technical measures referred to in Article 32 of said Regulation (EU) No. 679/2016 and shall carry out any security checks as required by ISO 27001 27011 as amended to protect the data, information and documents (both printed and digital). The archiving system shall guarantee not only the integrity of the data, information and printed/digital documents but also their future legibility throughout the mandatory conservation period. To fulfil such obligation both the Sponsor and the Entity may rely on external service providers to manage the archiving obligation.
2.9 The Sponsor, the Entity and the Principal Investigator shall comply with the directions, indications, instructions and recommendations given by the Ethics Committee and by the Competent Authority.
Appears in 2 contracts
Samples: Clinical Investigation Agreement, Clinical Investigation Agreement
Subject of the Agreement. 2.1 The Sponsor/CRO hereby entrusts the Entity with the execution of the Trial under the terms of this Agreement, in accordance with the Protocol and any subsequent amendments, and with the amendments to this Agreement/budget resulting from such amendments formalised by the necessary deeds of amendment, duly signed.
2.2 The Trial is to be conducted in strict compliance with the Protocol, in the version in force as accepted by the Principal Investigator and approved by the Ethics Committee and the Competent Authority in conformity with the laws applicable to clinical drugs trials and the principles of ethics and medical practice followed by the healthcare staff involved in the Trial in any capacity.
2.3 The Trial shall also be conducted in accordance with the principles of the Convention on Human Rights and Biomedicine, the updated version of the Helsinki Declaration, the 2008 Istanbul Declaration, the current rules of good clinical practice, and in accordance with the applicable laws on transparency, anti-corruption and the current data protection regulations.
2.4 By signing this Agreement, the Parties declare that they know and accept the contents of the above rules and regulations.
2.5 The Sponsor and the Principal Investigator have an obligation to protect patients’ safety and, where required in the circumstances, may take urgent, appropriate measures to protect patients’ safety such as temporarily suspending the Study (interruption of treatment for patients already enrolled or interruption of the enrolment of new patients), even without the necessary approval of the Ethics Committee and the Competent Authority, subject to the Sponsor's obligation to inform the Ethics Committee and the Competent Authority immediately of any new events, the measures taken, and the programme of measures to be taken in the future, and will duly complete the procedures required by the applicable laws.
(a) In the case of non-competitive inclusion of patients or
(b) In the case of a multi-centre competitive-enrolment trial
2.7 The Entity and the Sponsor will keep the Trial documentation (the “Trial Master File”) for the period of time specified in the applicable laws. The Entity agrees, as of the date of this Agreement, to keep the documentation for a period of seven years (or for a longer period if required by other applicable laws or by a financial agreement between Entity and the Sponsor). The Sponsor is obligated to inform the Centre of the expiry of the mandatory conservation period (only if requested). At the request of the Sponsor, after expiry of the mandatory conservation period, the Parties may agree the terms of a further conservation period.
2.8 The Entity and the Sponsor, each within their own sphere of responsibility, shall also use forms of digitalisation (or dematerialisation) to conserve the documentation. Regardless of whether or not the archived Trial documentation contains personal data (of a special nature or otherwise), according to the definitions in Regulation (EU) No. 679/2016, the Entity and the Sponsor shall take all the physical and technical measures referred to in Article 32 of said Regulation (EU) No. 679/2016 and shall carry out any security checks as required by ISO 27001 as amended to protect the data, information and documents (both printed and digital). The archiving system shall guarantee not only the integrity of the data, information and printed/digital documents but also their future legibility throughout the mandatory conservation period. To fulfil such obligation both the Sponsor and the Entity may rely on external service providers to manage the archiving obligation.
2.9 The Sponsor, the Entity and the Principal Investigator shall comply with the directions, indications, instructions and recommendations given by the Ethics Committee and by the Competent Authority.
3.1 The Principal Investigator shall be supported in the execution of the Trial by the healthcare and non-healthcare personnel and by any contractors engaged by the Entity, as appointed by the Entity and operating under its responsibility for all aspects pertaining to this Trial, who are qualified to conduct the Trial, and who have previously received adequate training as provided for in the applicable laws, by the Sponsor/CRO and who have declared their willingness to take part in the Trial (the Co-investigators). Without affecting the foregoing, the definition of “Investigators” does not include any medical or non-medical personnel who perform proprietary institutional activities in the context of the Trial (for example hospital pharmacists who prepare the trial drugs).
3.2 The Parties acknowledge that the Principal Investigator is bound by all the responsibilities and obligations imposed on their role by the applicable regulations on clinical drug trials.
3.3 This Agreement is made between the Sponsor/CRO and the Entity. The Sponsor/CRO is extraneous to the relations between the Entity, the Principal Investigator and the Co-investigators, and is thus indemnified in respect of any claim that the personnel of the Entity involved in the study may make in relation to the Trial.
3.4 In relation to the Trial, the Principal Investigator and the Co-investigators may not receive any direct or indirect compensation from the Sponsor/CRO, nor have any contact or dealings with the Sponsor/CRO or relations of any kind that are not of a technical or scientific nature.
3.5 If the relationship between the Principal Investigator and the Entity ends for any reason, the Entity will inform the Sponsor/CRO in writing and indicate the name of a replacement. The named replacement must be approved by the Sponsor/CRO and by the competent Ethics Committee. The Entity guarantees that the new Principal Investigator is qualified to continue the Trial, that they will accept the terms and conditions of this Agreement and that they will agree to respect the Protocol when executing the Trial. Pending approval of the substantial amendment for the change of Principal Investigator, the investigator indicated by the Sponsor shall carry out the necessary trial activities. If the Sponsor/CRO does not intend to accept the name of the replacement proposed by the Entity, or if the Entity does not propose a substitute, the Sponsor/CRO may terminate this Agreement in accordance with the provisions of Article 7.
3.6 Before starting the Trial, the Principal Investigator shall obtain the informed consent of the patient or his/her legal representative in accordance with the current laws on clinical trials, and also in accordance with Regulation (EU) 2016/679 and the Italian enacting laws (legislative decree 196 of 30 June 2003 as amended by legislative decree 101 of 10 August 2018). Consent shall also be provided for the processing of personal data in accordance with the current Italian and EC laws on data protection as amended, and as outlined in Article 11 below.
3.7 The Principal Investigator shall provide information to the Sponsor/CRO and to the Ethics Committee in relation to the progress of the Trial and shall promptly inform the Sponsor/CRO of any serious adverse events, subject to any other obligations to report to the Ethics Committee in accordance with current regulations, plus any other clinical information that is relevant to the study and indicated in the Protocol (e.g: pregnancy) that is directly or indirectly related to the execution of the Trial, in accordance with the provisions of the Protocol, the rules of Good Clinical Practice and the laws applicable to pharmacovigilance and clinical drugs trials.
3.8 The Entity guarantees that the Principal Investigator shall undertake to execute the Trial in accordance with the highest standards of diligence.
3.8.1 The Principal Investigator shall keep all of the Case Report Forms (CRF), duly compiled, in accordance with the terms and conditions of the Protocol for the trial and with the applicable regulations, in printed or digital form and in any case they shall be delivered promptly in accordance with the GCP, by the date indicated in the trial Protocol.
3.8.2 The Principal Investigator shall also resolve any queries raised by the Sponsor/CRO by the date indicated in the trial Protocol.
3.8.3 To verify the correspondence between the data recorded on the CRF and the data contained in the original clinical records, the Entity and the Principal Investigator shall allow direct access to the source data during the monitoring visits and any audits by the Sponsor/CRO and inspections by the Competent Authorities, including remote methods, provided that the laws on confidentiality and patient privacy are respected.
3.8.4 The Entity and the Principal Investigator, having been informed sufficiently in advance, shall allow the correct execution of the monitoring and auditing at the Trial Centre ______ by the Sponsor/CRO and by the Competent Authority, such activities to be carried out to guarantee the proper execution of the Trial.
Appears in 1 contract
Samples: Clinical Investigation Agreement
