Answer»
- The clinical trials should be conducted in accordance with the ethical principles based on the declaration of Helsinki and GCP and regulatory requirements
- Before a trial is INITIATED, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and CONTINUED only if the anticipated benefits justify the risks.
- The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
- Available clinical and non clinical information on the product should adequate to support the proposed clinical trial
- Trial should be scientifically sound and described in a CLEAR, detailed protocol
- A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion.
- The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
- Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s)
- Freely given informed consent should be obtained from every subject prior to clinical trial participation.
- All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
- The confidentiality of records that COULD identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s)
- Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). Theyshould be used in accordance with the approved protocol.
- Systems with procedures that assure the quality of every aspect of thetrial should be implemented
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