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.
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.
CRO-mCTA-UK-February_2018.docx