Good Clinical Practice (GCP) guidelines .

Good Clinical Practice is a set of guidelines for biomedical studies which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human subjects. AIM: To ensure that the studies are scientifically and ethically sound and that the clinical properties of the pharmaceutical substances under investigation are properly documented. The guidelines seek to establish two cardinal principles: protection of the rights of human subjects and authenticity of biomedical data generated. PURPOSE: To avoid research misconduct and fraud as this is growing public & professional concern nowadays. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origins in the declaration of Helsinki These guidelines have been evolved with consideration of WHO, ICH, USFDA and European GCP guidelines as well as the Ethical Guidelines for Biomedical research on Human Subjects issued by the Indian Council of Medical Research. WHO has laid down some important principles of GCP which include Principle1: All research involving human subjects should be conducted in accordance with the ethical principles contained in the current revision of Declaration of Helsinki and should respect three basic principles, namely justice, respect for persons, beneficence (to maximize benefits and to minimize harms and wrongs) and non malaficence (to do no harm) as defined by Ethical Guidelines for Biomedical Research on Human Subjects.

Principle2: Research involving humans should be scientifically justified and described in a clear, detailed protocol. Principle3: Before research involving humans is initiated, foreseeable risks and discomforts and any anticipated benefits for the individual research subject & society should be identified. Principle4: Research involving humans should be initiated only if the anticipated benefits for the individual research subject and society clearly outweigh the risks. The most important considerations are those related to the rights, safety and wellbeing of the research subjects. Principle5: Research involving humans should receive independent Ethics committee/ institutional review board (IEC/IRB) approval prior to initiation. Principle6: Research involving humans should be conducted in compliance with the approved protocol. Principle7: Freely given informed consent should be obtained from every subject prior to research participation in accordance with national cultures and requirements. When a subject is not capable of giving informed consent, the permission of a legally authorized representative should be obtained in accordance with applicable law. Principle8: Research involving humans should be continued only if the benefitrisks profile remains favorable. Principle9: Qualified and duly licensed medical personnel should be responsible for the medical care of research subjects, and for any medical decisions made on their behalf. Principle10: Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective tasks and currently licensed to do so, where required.

Principle11: All clinical trial information should be recorded , handled and stored in a way that allows its accurate reporting, interpretation and verification. Principle12: The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements. Principle13: Investigational products should be manufactured, handled and stored in accordance with applicable Good Manufacturing Practice(GMP). Principle14: systems with procedures that assure the quality of every aspect of the trial should be implemented.