Personnel, and further, the Principal Investigator must have obtained consent from the substantive employer for participation in the Clinical Trial; 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 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 Trial are available at the Participating Organisation and that in the performance of obligations under this Agreement, is satisfied that he/she will be supported by medical and other staff of sufficient number and experience to enable the Participating Organisation to perform the Clinical Trial efficiently and in accordance with the obligations under this Agreement; Where the 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 Participating Organisation. During the Clinical Trial, the Principal Investigator will not serve as principal investigator or sub-investigator in any clinical for another sponsor if such activity may adversely affect the ability of the Principal Investigator to perform his/her obligations under this Agreement; The Participating Organisation carries medical liability insurance covering the Principal Investigator and the details and evidence of the coverage will be provided to the Sponsor upon request. Appendix 6 Material Transfer Provisions – [DELETE IF NOT APPLICABLE] Where the Protocol requires the Participating Organisation to supply Material to the Sponsor or CRO this Appendix 6 shall apply. In accordance with the Protocol, the Participating Organisation shall send Material to the Sponsor, CRO or, in accordance with Section 7 below, to a third party nominated by the Sponsor or CRO. The Participating Organisation warrants that all Material has been collected with appropriate informed consent and has been collected and handled in accordance with applicable law (including, without limitation, the Human Tissue Act 2004) and as required by the Protocol. Subject to Section 2 above, the Material is supplied without any warranty, expressed or implied, including as to its properties, merchantable quality, fitness for any particular purpose, or freedom from infection. The Sponsor or CRO shall ensure, or procure through an agreement with the nominee of the Sponsor or CRO as stated in item 1 above that:
Personnel, and further, the Principal Investigator must have obtained consent from the substantive employer for participation in the Clinical Trial; 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 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 Trial are available at the Participating Organisation and that in the performance of obligations under this Agreement, is satisfied that he/she will be supported by medical and other staff of sufficient number and experience to enable the Participating Organisation to perform the Clinical Trial efficiently and in accordance with the obligations under this Agreement; Where the 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 Participating Organisation. During the Clinical Trial, the Principal Investigator will not serve as principal investigator or sub-investigator in any clinical for another sponsor if such activity may adversely affect the ability of the Principal Investigator to perform his/her obligations under this Agreement; The Participating Organisation carries medical liability insurance covering the Principal Investigator and the details and evidence of the coverage will be provided to the Sponsor upon request. Appendix 6 – Material Transfer Provisions [DELETE IF NOT APPLICABLE] Where the Protocol requires the Participating Organisation to supply Material to the Sponsor or CRO this Appendix 6 shall apply. In accordance with the Protocol, the Participating Organisation shall send Material to the Sponsor, CRO or, in accordance with Section 7 below, to a third party nominated by the Sponsor or CRO. The Participating Organisation warrants that all Material has been collected with appropriate informed consent and has been collected and handled in accordance with applicable law (including, without limitation, the Human Tissue Act 2004) and as required by the Protocol. Subject to Section 2 above, the Material is supplied without any warranty, expressed or implied, including as to its properties, merchantable quality, fitness for any particular purpose, or freedom from infection. The Sponsor or CRO shall ensure, or procure through an agreement with the nominee of the Sponsor or CRO as stated in item 1 above that:
CRO-mCTA-UK-February_2018.docx