The Importance Of Good Clinical Practice

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2. Sufficiency and compassion: Principle of sufficiency elicits compassion and forces us to not only take into account others who are affected by our decisions, it also coaxes us into displaying empathy for the situations of others. Without sufficiency and compassion, justice remains precariously elusive.
3. Solidarity: Solidarity does not stop with humans; it also urges us to consider our relationships with the environment and everything around us. Solidarity also demands active participation in ethical reasoning without solidarity, the principles of justice and sufficiency and compassion are merely choices rather than the foundation of ethical reasoning.
Approaches to ethics decision making includes
- Teleological: Actions are judged as …show more content…

This concept is of great significance because it helps to harmonize the regulations and guidelines for drug development. It provides a United standard to facilitate the mutual acceptance of clinical data by the regulatory authorities, and removes redundancy or duplication in development and review process. One of the great challenges in applying good clinical practices is defining the roles and responsibilities of those involves and ensuring a dynamic process in which contributions are complementary. Evidence-based medicine is the standard of care for treatment of disease. Through clinical research, we expand on that knowledge to improve evidence-based standards. In the United states, clinical trials have been a standard approach to the care of children with cancer since 1960s. because childhood cancer is rare, advances in therapy depends on collaborative clinical trials conducted by cooperative groups and consortia (Devine et al …show more content…

Mary countries have adopted good clinical practices as laws and/or regulations. Good clinical practices are suitable for research teams involved in clinical trials of dings, biologics, and devices Good clinical practices (GCP) for clinical trials with investigations drugs and medical devices is suitable for individuals proposing to conduct clinical trials of drugs and devices primarily in the U.S and/or who would prefer a more U.S FDA centric curriculum.

GCLP for clinical trials with investigational drugs and bio logics is suitable for individuals involved in clinical trials of drugs and biologics when the research may be international or where the individuals would prefer a more ICH focused curriculum. GCP for clinical investigations of devices is most appropriate for organization or individuals who desire a more international focused GCP curriculum or a more device focused program.

10.5 Current

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