Claims pursuant to the Guidelines should be made by the patient to the company, preferably via the investigator, setting out details of the nature and background of the claim and, subject to the patient providing on request an authority for the company to review any medical records relevant to the claim, the company should consider the claim expeditiously. The undertaking by a company extends to injury arising (at whatever time) from all administrations, clinical interventions or procedures occurring during the course of the trial but not to treatment extended beyond the end of the at the instigation of the investigator. The use of unlicensed products beyond the period is wholly the responsibility of the treating doctor. The fact that a company has agreed to abide by these Guidelines in respect of a does not affect the right of a patient to pursue a legal remedy in respect of injury alleged to have been suffered as a result of participation. Nevertheless, patients will normally be asked to accept that any payment made under the Guidelines will be in full settlement of their claims. A company sponsoring a trial should encourage the investigator to make clear to participating patients that the is being conducted subject to the ABPI Guidelines relating to compensation for injury arising in the course of clinical trials and have available copies of the Guidelines should they be requested. If a legal remedy is pursued and the case is the subject of adjudication or settlement, the patient may not bring a further claim, based on the same facts, under these Guidelines.
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: