International Congress on Harmonization Term Paper

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International Congress on Harmonization

Clinical research guidelines

There are various bodies that are concerned with the stipulation of guidelines and rules that need to be followed within the medical field and in specific the clinical research areas. The guidelines have been summarized by the International Conference on Harmonization (ICH) into five major areas: those dealing with quality, safety, efficacy and multidisciplinary topics. Within the patient care discipline, guidelines are designed predominantly to support decision making process and the content of these guidelines are based on data from the evidence based approach that has been gathered over time hence has a wide application and reach. Evidence-based care has been gaining ground in the recent years, propagated by the clinicians, managers and even politicians who are concerned about the quality standards. This has further heightened the need and requirement of standards among the practitioners in the healthcare sector (Open Clinical, 2013).

There are various purposes that the guidelines serve hence the need to have the clinical research practices put in line with the prescribed guidelines. The guidelines are meant to describe the appropriate care that patients should be given based on the scientific evidence that is available to the clinicians and the broad consensus. This means that even as the individual carries out the clinical research, he should ensure that it adheres to the consensus and the scientific evidence that guides that particular area of medical practice in order to ensure that safety of all involved in the research.

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Clinical researches, in as a much as may be in different fields, the variations should not be so wide that it digresses from the set out standards. The role of the guidelines that are stipulated by the various bodies in the medical practice is to ensure that there are no inappropriate variations in the clinical practices when conducting research. If the researcher goes to the field without a set of guidelines on how a clinical research ought to be conducted, it will mean that the each researcher may come in with their own approaches and results which will inevitably be quite varied hence distorting the approach towards clinical research. This is where the guidelines are deemed significant to ensure all the successive researches conducted have a uniform direction hence keeping the integrity of the clinical research practice.

The guidelines that are set within the clinical research field are made up of previously observed trends and proven practices. This means that the clinical researches that are to be carried out will have a rational basis upon which their referrals will be drawn. The researchers will need a constant point where they can be making references from and the point of reference needs to be a reliable one that is backed up with factual details and guides. This can only achieved through the use of the stipulated guidelines and standards set out by the relevant bodies in the field of….....

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