Research to ensure that new vaccines, drugs, treatments, etc., are safe and effective. Participants must be advised of their rights to compensation in the event of consequential injury, illness or impairment otherwise the trial will not be authorised under European legislation or by an ethics committee. See CLINICAL TRIAL INSURANCE.
Insurance Encyclopedia
Clinical Trial Insurance Policy for Liability Insurance
The policy covers the sum which the insured shall be liable to pay as damages/compensation for claims made by subjects for death or injury or any other adverse reaction in the body as a result of participating in clinical trial. The term insured would include all stakeholders in the trial. The cover includes legal costs also. Breaches of data may also be covered. The policy is generally issued on NO Fault principle. The policy may be a single trial or multi trial policy. Post-trial coverage is also offered for a limited period as decided. The territorial limits are also specified. The policy does not extend to cover (i) Damages within permissible limits as are to be expected within such trials. (ii) Deliberate contravention of instructions by the subject (iii) Deterioration in condition which would normally have occurred even without the trial (iv) War and nuclear perils (v) Fines and Penalties.
Clinical trials
One of the final stages of a long and careful research process to help patients live longer, healthier lives. Clinical trials help doctors and researchers find better ways to prevent, diagnose, or treat diseases. They test new types of medical care such as how well a new cancer drug works and if it is safe. The trials may also be used to compare different treatments for the same condition to see which is better or to test new uses for treatments already employed.
Clinicial trial insurance
Claims-made policy for research organisations, drug manufacturers, hospitals, universities, etc., involved in clinical trials. The insurer indemnifies the policyholder in the sums they have agreed to pay to trial participants for injuries regardless of fault. Claimants may prefer to make normal legal liability claims rather than use the agreed arbitration/ compensation processes. If so, the policyholder’s legal liability is covered under a second section of the policy.
Clinician
General term denoting a medical or dental practitioner who has hospital staff admission privileges and primary responsibility for care of inpatients.
Cloning
1. When each entry in a patient’s medical record is worded exactly alike or similar to the previous entries. 2. When medical documentation is worded exactly the same from patient to patient. Cloning is considered a misrepresentation of the medical necessity requirements for insurance coverage of medical services. If suspected or identified, the services will be denied and may result in recovery of any overpayments made.
Close
Conclusion of the sales presentation that leads to the signing of the insurance application.
Close links
A linkage between an FSAauthorised firm and another firm or entity falling into one of a number of defined categories, viz: a parent company; a subsidiary; a subsidiary of a parent company; entities or persons owning or controlling 20 per cent of the voting rights or capital; companies in respect of which the firm owns 20 per cent or more of the voting rights or capital. The FSA is concerned to satisfy itself that, taking account of close links, it can exercise its supervisory function effectively.
Close or closely held corporation
A corporation that is owned by a small number of individuals who are related. A close corporation fills its own vacancies.
Closed access
Managed care plan that requires enrollees to select a primary care physician (PCP) from the plan’s approved panel of providers. The PCP acts as a gatekeeper and may refer the patient to a specialist when required.