All Other Fees. [Insert content in the All Other Fees section of the iCT export here.] Appendix 5 – Conditions Applicable to the Principal Investigator The Principal Investigator is free to participate in the Clinical Investigation and there are no rights that may be exercised by, or obligations owed to, any third party that may prevent or restrict the performance by the Principal Investigator of the obligations set out in the Agreement. Where the Trial Site is not the Principal Investigator’s substantive employer, the Principal Investigator must notify their substantive employer of the proposed participation in the Clinical Investigation and where relevant, the supervision of Personnel, and further, the Principal Investigator must have obtained consent from the substantive employer for participation in the Clinical Investigation. The Principal Investigator is not the subject of any regulatory litigation or misconduct litigation or investigation. No data produced by the Principal Investigator in any other clinical study has been rejected because of concerns as to its accuracy or because it was generated by fraudulent means. The Principal Investigator has considered and is satisfied that facilities appropriate to the Clinical Investigation are available at the Trial Site Site, and any Other Trial Sites, and that in the performance of obligations under this Agreement, is satisfied that they will be supported by medical and other staff of sufficient number and experience to enable the Trial Site, and any Other Trial Site(s), to perform the Clinical Investigation efficiently and in accordance with the obligations under this Agreement. Where the Trial Site is not the Principal Investigator’s substantive employer, the Principal Investigator holds a contract for services (commonly known as an honorary contract) with the Trial Site. During the Clinical Investigation, the Principal Investigator will not serve as principal investigator or sub-investigator in any clinical study for another sponsor if such activity may adversely affect the ability of the Principal Investigator to perform their obligations under this Agreement. The Trial Site carries medical liability insurance covering the Principal Investigator, or is otherwise covered by an equivalent NHS scheme, and the details and evidence of the coverage will be provided to the Sponsor upon request.
Appears in 1 contract
Samples: Clinical Investigation Agreement
All Other Fees. [Insert content in the All Other Fees section of the iCT export here.] Appendix 5 – Conditions Applicable to the Principal Investigator The Principal Investigator is free to participate in the Clinical Investigation Trial and there are no rights that may be exercised by, or obligations owed to, any third party that may prevent or restrict the performance by the Principal Investigator of the obligations set out in the Agreement. Where the Trial Site is not the Principal Investigator’s substantive employer, the Principal Investigator must notify their substantive employer of the proposed participation in the Clinical Investigation Trial and where relevant, the supervision of Personnel, and further, the Principal Investigator must have obtained consent from the substantive employer for participation in the Clinical InvestigationTrial. The Principal Investigator is not the subject of any regulatory litigation or misconduct litigation or investigation. No data produced by the Principal Investigator in any other clinical study trial has been rejected because of concerns as to its accuracy or because it was generated by fraudulent means. The Principal Investigator has considered and is satisfied that facilities appropriate to the Clinical Investigation Trial are available at the Trial Site Site, and any Other Trial SitesSite(s), and that in the performance of obligations under this Agreement, is satisfied that they will be supported by medical and other staff of sufficient number and experience to enable the Trial Site, and any Other Trial Site(s), to Site(s),to perform the Clinical Investigation Trial efficiently and in accordance with the obligations under this Agreement. Where the Trial Site is not the Principal Investigator’s substantive employer, the Principal Investigator holds a contract for services (commonly known as an honorary contract) with the Trial Site. During the Clinical InvestigationTrial, the Principal Investigator will not serve as principal investigator or sub-investigator in any clinical study trial for another sponsor if such activity may adversely affect the ability of the Principal Investigator to perform their obligations under this Agreement. The Trial Site carries medical liability insurance covering the Principal Investigator, or is otherwise covered by an equivalent NHS scheme, and the details and evidence of the coverage will be provided to the Sponsor upon request.
Appears in 1 contract
Samples: Clinical Trial Agreement
All Other Fees. [Insert content in the All Other Fees section of the iCT export here.] Appendix 5 – Conditions Applicable to the Principal Investigator The Principal Investigator is free to participate in the Clinical Investigation Trial and there are no rights that may be exercised by, or obligations owed to, any third party that may prevent or restrict the performance by the Principal Investigator of the obligations set out in the Agreement. Where the Trial Site is not the Principal Investigator’s substantive employer, the Principal Investigator must notify their substantive employer of the proposed participation in the Clinical Investigation Trial and where relevant, the supervision of Personnel, and further, the Principal Investigator must have obtained consent from the substantive employer for participation in the Clinical InvestigationTrial. The Principal Investigator is not the subject of any regulatory litigation or misconduct litigation or investigation. No data produced by the Principal Investigator in any other clinical study trial has been rejected because of concerns as to its accuracy or because it was generated by fraudulent means. The Principal Investigator has considered and is satisfied that facilities appropriate to the Clinical Investigation Trial are available at the Trial Site Site, and any Other Trial SitesSite(s), and that in the performance of obligations under this Agreement, is satisfied that they will be supported by medical and other staff of sufficient number and experience to enable the Trial Site, and any Other Trial Site(s), to perform the Clinical Investigation Trial efficiently and in accordance with the obligations under this Agreement. Where the Trial Site is not the Principal Investigator’s substantive employer, and the Principal Investigator is not a partner at the Trial Site, the Principal Investigator holds a contract for services (commonly known as an honorary contract) with the Trial Site. During the Clinical InvestigationTrial, the Principal Investigator will not serve as principal investigator or sub-investigator in any clinical study trial for another sponsor if such activity may adversely affect the ability of the Principal Investigator to perform their obligations under this Agreement. The Trial Site carries Principal Investigator and Personnel carry medical liability insurance covering the Principal Investigatorinsurance, or is are otherwise covered by an equivalent NHS scheme, and the details and evidence of the coverage will be provided to the Sponsor upon request.
Appears in 1 contract
Samples: Clinical Trial Agreement
All Other Fees. [Insert content in the All Other Fees section of the iCT export here.] Appendix 5 – Conditions Applicable to the Principal Investigator The Principal Investigator is free to participate in the Clinical Investigation and there are no rights that may be exercised by, or obligations owed to, any third party that may prevent or restrict the performance by the Principal Investigator of the obligations set out in the Agreement. Where the Trial Site is not the Principal Investigator’s substantive employer, the Principal Investigator must notify their substantive employer of the proposed participation in the Clinical Investigation and where relevant, the supervision of Personnel, and further, the Principal Investigator must have obtained consent from the substantive employer for participation in the Clinical Investigation. The Principal Investigator is not the subject of any regulatory litigation or misconduct litigation or investigation. No data produced by the Principal Investigator in any other clinical study has been rejected because of concerns as to its accuracy or because it was generated by fraudulent means. The Principal Investigator has considered and is satisfied that facilities appropriate to the Clinical Investigation are available at the Trial Site Site, and any Other Trial SitesSite(s), and that in the performance of obligations under this Agreement, is satisfied that they will be supported by medical and other staff of sufficient number and experience to enable the Trial Site, and any Other Trial Site(s), to perform the Clinical Investigation efficiently and in accordance with the obligations under this Agreement. Where the Trial Site is not the Principal Investigator’s substantive employer, the Principal Investigator holds a contract for services (commonly known as an honorary contract) with the Trial Site. During the Clinical Investigation, the Principal Investigator will not serve as principal investigator or sub-investigator in any clinical study for another sponsor if such activity may adversely affect the ability of the Principal Investigator to perform their obligations under this Agreement. The Trial Site carries medical liability insurance covering the Principal Investigator, or is otherwise covered by an equivalent NHS scheme, and the details and evidence of the coverage will be provided to the Sponsor upon request.
Appears in 1 contract
Samples: Clinical Investigation Agreement
All Other Fees. [Insert content in the All Other Fees section of the iCT export here.] Appendix 5 3 – Conditions Applicable to the Principal Investigator The Principal Investigator is free to participate in the Clinical Investigation Non-Interventional Study and there are no rights that may be exercised by, or obligations owed to, any third party that may prevent or restrict the performance by the Principal Investigator of the obligations set out in the Agreement. ; Where the Trial Site Participating Organisation is not the Principal Investigator’s substantive employer, the Principal Investigator must notify their substantive employer of the proposed participation in the Clinical Investigation Non-Interventional Study and where relevant, the supervision of Personnel, and further, the Principal Investigator must have obtained consent from the substantive employer for participation in the Clinical Investigation. Non-Interventional Study; The Principal Investigator is not the subject of any regulatory litigation or misconduct litigation or investigation. No data produced by the Principal Investigator in any other clinical study has been rejected because of concerns as to its accuracy or because it was generated by fraudulent means. ; The Principal Investigator has considered and is satisfied that facilities appropriate to the Clinical Investigation Non-Interventional Study are available at the Trial Site Site, and any Other Trial Sites, Participating Organisation and that in the performance of obligations under this Agreement, is satisfied that they will be supported by medical and other staff of sufficient number and experience to enable the Trial Site, and any Other Trial Site(s), Participating Organisation to perform the Clinical Investigation Non-Interventional Study efficiently and in accordance with the obligations under this Agreement. ; Where the Trial Site Participating Organisation is not the Principal Investigator’s substantive employer, the Principal Investigator holds a contract for services (commonly known as an honorary contract) with the Trial Site. Participating Organisation; During the Clinical InvestigationNon-Interventional Study, the Principal Investigator will not serve as principal investigator or sub-investigator in any clinical study for another sponsor if such activity may adversely affect the ability of the Principal Investigator to perform their obligations under this Agreement. ; The Trial Site Participating Organisation carries medical liability insurance covering the Principal Investigator, or is otherwise covered by an equivalent NHS scheme, and the details and evidence of the coverage will be provided to the Sponsor upon request.
Appears in 1 contract
Samples: Clinical Research Organisation Model Non Interventional Study Agreement (Cro Mnisa)