An Overview on Good Clinical Practice

Clinical research is critical to determine the safety and usefulness of express health and medical products and practices. Most of what is known today about the safety and efficiency of express products and treatments has come from randomized controlled clinical tests that are designed to answer important systematic and medicare questions. Randomized controlled trials form the footing for “evidence-based medicine”, but such research can be depended upon only if it is conducted according to guidelines and standards collectively known as “good clinical research practice”.

The Handbook for Good Clinical Research Practice—Guidance for Implementation by the World Health Organisation outlined good clinical practice as “a process that incorporates established ethical and scientific quality standards for the design, conduct, recording and reporting of clinical research involving the collaboration of human subjects.”

On the other hand, the European Union Directive 2001/20/EC, article 1, clause 2 outlined good clinical practice as a “set of known internationally moral and scientific quality requirements which should be observed for designing, conducting, recording and reporting trials that involve the collaboration of human subjects.”

Listed below are a few of the core principles of good clinical practice as noted in the United States, Western european Union member states and Asian countries:

1. Trials should be conducted as per ethical beliefs that have their origin in the Stipulation of Helsinki, and that match with GCP and the applicable regulatory duty (s).

2. Before a trial is initiated, predictable risks and inconveniences should be weighed against anticipated benefit for the individual trial subject and society. A trial should be began and continued only if the anticipated benefits explain the hazards.

3. The rights, safety and well-being of the trial subjects are the most significant points to consider and should prevail over interest of science and society.

4. The available non-clinical and clinical info on an investigational product should be sufficient to support the suggested medical trial.

5. Medical trials should be scientifically sound, and described in clear, detailed custom.

These principles are self-explanatory and, when summarised, simply mean: All controlled trials should be conducted as per moral principles, sound systematic proof and clear detailed customs. The advantages of conducting trials should outweigh the hazards. The rights, safety and well-being of trial players are of paramount significance and these should be saved by getting informed consent and maintaining confidentiality. The care must be given by reasonably qualified personnel with sufficient experience. Records should be easily reached and retrievable for correct reporting, verification and interpretation.

The guidelines on good clinical practice are considered the ‘bible ‘ of clinical trials, and have become a global law which guarantees humanity as we all know it today.

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