GOOD CLINICAL PRACTICES AND GOOD MANUFACTURING PRACTICES FOR INVESTIGATIONAL MEDICINAL PRODUCTS.

GOOD CLINICAL PRACTICES AND GOOD MANUFACTURING PRACTICES FOR INVESTIGATIONAL MEDICINAL PRODUCTS.

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Good Clinical Practice

According to the European Medicines Agency (2002), a good Clinical Practice are guidelines that set the standards for design, conduct, performance, monitoring, auditing , recording, analysing and reporting of clinical trials providing that the data collected and the results are credible and accurate while maintaining integrity and confidentiality of trial subjects. Many countries have specified guidelines they adhere to when conducting clinical trials to ensure integrity of human subjects. Most guidelines ensure that an informed consent is obtained from the participating trial subjects and that the person conducting the trials is qualified and well conversant with the guidelines and all procedures to ensure that the scientific interests do not surpass human rights and well being. It is within the provisions that the investigator should have alternative methods of treatment if the investigational medicinal product brings adverse effects that had not been predicted or if the subject decides to quit the trial before he is completely cured. Participants should be compensated if a clinical trial leads to health destruction to an individual who was otherwise healthy, (European Commission Enterprise Directorate-general, July 2002).

Directive 2005/28/EC

Good Clinical practices according to the Directive 2005/28/EC states that the rights, well being and safety of trial subjects should be held paramount to other societal interests of the researcher, (Commission Directive 2005/28/EC, April 2005). This is to mean that if the subjects will not be safe, then the clinical trials should stop. It is required for those conducting the research to be qualified by education in their specialty in the role they play during the trials and proper guidelines should be set up and defined to ensure that this takes place. If the drug is being administered through injection, it is important that only those who know how to use syringes will conduct the exercise. Ethical principles are supposed to be used during the entire clinical process to ensure that the safety of the trial subjects is maintained. The quality of the clinical trials aspects procedures should also be followed. Proposals for clinical trials are supposed to be accompanied by non-clinical and clinical information on concerning the investigational medicinal product. This information is supposed to be adequate. Declaration of Helsinki on Ethical Principles for Medicinal Research Involving Human Subjects should be followed for good clinical practices. Article four of this directive refers to article 2 point h in directive 2001/20/EC which provides a definition on who can be included or omitted from participating in clinical trials, monitoring of the trials and public policy. Guidance on commencing and conducting clinical trail is supposed to be followed by the investigator and sponsor. Article five puts emphasis on the recording of all data collected during the clinical trial. The recording, handling and storage should be done in a manner that it can be reported accurately, properly interpreted and verified while maintaining the confidentiality of trial subjects. To ensure that unnecessary clinical trails do not take place, it is important for the member state to come up with clear guidelines stipulating when a clinical trail can be accepted, (European Medicines Agency,

2002).

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