Good Clinical Practices
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An Introduction to Good Clinical P ractice
What does the term “Good Clinical Practice” mean? Good Clinical Practice (GCP) is defined in the International Conference on Harmonization (ICH) guideline as an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. This standard ensures that the rights and safety of the trial subjects are protected and that the trial results are credible.
A Brief History Following WWII and during the Nuremberg trials, it became clear what atrocities the Nazi doctors committed 'in the name of medical science'. During their trial the Nazi doctors argued in their defense that there was no international law or informal statement that differentiated between legal and illegal experiments on humans. On 17 April, 1947 two US doctors who worked for the prosecution on the trials, submitted a text with six points defining legitimate research. These six points became ten points and are now known as the Nuremberg Code.
A brief history II These ten items were later incorporated in the Declaration of Helsinki, written in 1964 by the World Medical Association (WMA), an international organization representing physicians. The declaration was a guideline that provided the highest ethical standards at that time.
A brief history III During the 1960s, Thalidomide was used in Europe as a treatment for insomnia, mostly in pregnant women. When the company who manufactured the drug made a submission to the FDA (US Food and Drug Administration) to market the drug on the American market, Frances Kelsey (an FDA employee) reviewed the application thoroughly and kept if off the market when she discovered that it caused birth defects when used on pregnant women.
A brief history IV Eventually, from the mid-1970s, the FDA found it necessary to reject clinical research from other countries, since they didn't have the same ethical and safety standards as the US. Europe and Japan each developed their own set of GCP guidelines, from the mid-1980s onwards. But the differences between the US, Europe and Japan remained and did not contribute to the economical efficiency of clinical trials: pharmaceutical companies had to invest in three different trials to globally market one single drug.
A brief history V
In 1996, an International Conference on Harmonisation (ICH) was called into being, consisting of authorities of Europe, US and Japan and experts form the pharmaceutical industries. This led to an international, uniform standard to accept the results of clinical trials, as long as they are conducted according to the ICHGCP guidelines on Safety, Quality, Efficiency and Multidisciplinary.
13 principles of Good Clinical Practice 1.
Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirements.
13 principles of Good Clinical Practice 1.
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.
13 principles of Good Clinical Practice 1.
The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
13 principles of Good Clinical Practice 1.
The available non-clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
13 principles of Good Clinical Practice 1.
Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
13 principles of Good Clinical Practice 1.
A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.
13 principles of Good Clinical Practice 1.
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.
13 principles of Good Clinical Practice 1.
Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
13 principles of Good Clinical Practice 1.
Freely given informed consent should be obtained from every subject prior to clinical trial participation.
13 principles of Good Clinical Practice 1.
All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
13 principles of Good Clinical Practice 1.
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).
13 principles of Good Clinical Practice 1.
Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
13 principles of Good Clinical Practice 1.
Systems with procedures that assure the quality of every aspect of the trial should be implemented.
From theoretical to practical Now let’s examine some violations of the guidelines of Good Clinical Practice or not. Which specific rule or rules do you think these scenarios do not follow?
This concludes our presentation on Good Clinical Practices. If you have any questions, please feel free to ask.
What does the term “Good Clinical Practice” mean? Good Clinical Practice (GCP) is defined in the International Conference on Harmonization (ICH) guideline as an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. This standard ensures that the rights and safety of the trial subjects are protected and that the trial results are credible.
A Brief History Following WWII and during the Nuremberg trials, it became clear what atrocities the Nazi doctors committed 'in the name of medical science'. During their trial the Nazi doctors argued in their defense that there was no international law or informal statement that differentiated between legal and illegal experiments on humans. On 17 April, 1947 two US doctors who worked for the prosecution on the trials, submitted a text with six points defining legitimate research. These six points became ten points and are now known as the Nuremberg Code.
A brief history II These ten items were later incorporated in the Declaration of Helsinki, written in 1964 by the World Medical Association (WMA), an international organization representing physicians. The declaration was a guideline that provided the highest ethical standards at that time.
A brief history III During the 1960s, Thalidomide was used in Europe as a treatment for insomnia, mostly in pregnant women. When the company who manufactured the drug made a submission to the FDA (US Food and Drug Administration) to market the drug on the American market, Frances Kelsey (an FDA employee) reviewed the application thoroughly and kept if off the market when she discovered that it caused birth defects when used on pregnant women.
A brief history IV Eventually, from the mid-1970s, the FDA found it necessary to reject clinical research from other countries, since they didn't have the same ethical and safety standards as the US. Europe and Japan each developed their own set of GCP guidelines, from the mid-1980s onwards. But the differences between the US, Europe and Japan remained and did not contribute to the economical efficiency of clinical trials: pharmaceutical companies had to invest in three different trials to globally market one single drug.
A brief history V
In 1996, an International Conference on Harmonisation (ICH) was called into being, consisting of authorities of Europe, US and Japan and experts form the pharmaceutical industries. This led to an international, uniform standard to accept the results of clinical trials, as long as they are conducted according to the ICHGCP guidelines on Safety, Quality, Efficiency and Multidisciplinary.
13 principles of Good Clinical Practice 1.
Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirements.
13 principles of Good Clinical Practice 1.
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.
13 principles of Good Clinical Practice 1.
The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
13 principles of Good Clinical Practice 1.
The available non-clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
13 principles of Good Clinical Practice 1.
Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
13 principles of Good Clinical Practice 1.
A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.
13 principles of Good Clinical Practice 1.
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.
13 principles of Good Clinical Practice 1.
Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
13 principles of Good Clinical Practice 1.
Freely given informed consent should be obtained from every subject prior to clinical trial participation.
13 principles of Good Clinical Practice 1.
All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
13 principles of Good Clinical Practice 1.
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).
13 principles of Good Clinical Practice 1.
Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
13 principles of Good Clinical Practice 1.
Systems with procedures that assure the quality of every aspect of the trial should be implemented.
From theoretical to practical Now let’s examine some violations of the guidelines of Good Clinical Practice or not. Which specific rule or rules do you think these scenarios do not follow?
This concludes our presentation on Good Clinical Practices. If you have any questions, please feel free to ask.
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