The laboratory is the fundamental source of the key scientific basis for clinical diagnosis and patient care clinical research and decision-making. High-quality laboratory results obtained from the analysis of samples collected by clinical trial participants are a key part of the clinical trial process. They provide critical data for evidence-based decision-making, research on the safety, effectiveness, and mechanism of action of drugs, and improve standard care. These data also need to protect the health and safety of clinical trial participants. Therefore, the laboratory must meet the quality and management standards so that the results of its production are unbiased, accurate, and complete.
Good Clinical Laboratory Practice (GCLP) is a set of standards that provides guidance for the implementation of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) principles for the analysis of clinical trial samples. GLP is a quality system (OECD 1998) that covers organizational processes and conditions for planning, execution, monitoring, recording, archiving, and reporting of non-clinical laboratory research. The purpose is to facilitate the generation of effective, high-quality test data. On the other hand, GCP is an international ethical and scientific quality standard involving the design, execution, execution, monitoring, audit, recording, analysis, and reporting of clinical trials involving human subjects. Compliance with this standard ensures that the results of data and reports are reliable and accurate, and the rights, safety, and confidentiality of subjects are protected (ICH 1996 GCP Guidelines).
By combining GLP and GCP guidelines, GCLP ensures the quality and reliability of clinical trial data generated by the laboratory. Therefore, GCLP is essential to the operation of clinical trial laboratories. It is expected that compliance with the GCLP standards monitored annually through external audits will help laboratories maintain the integrity of clinical trial data, provide safety for research participants, and produce consistent effectiveness. The results are auditable and repeatable.
GCLP provides a bridge between GCP and GLP. It is also a framework in which organizations can ensure that laboratory work and results meet the expectations of GLP and GCP based on the development of facilities, systems, and procedures.
GCLP covers all aspects of clinical trial laboratory operations, namely: organization and personnel; equipment; equipment, materials, and reagents; standard operating procedures; work planning; subcontracting; trial materials; results of work report; quality control and quality audit; storage And keep study records and reports, and keep confidential.
Alzheimer's disease (AD) and vascular disease are the most common causes of Alzheimer's disease. It is estimated that more than 35 million people worldwide suffer from dementia, mainly Alzheimer's disease. [1] In the past 30 years, there has been a proliferation of imaging techniques to examine structural and functional brain changes associated with dementia and to identify biomarkers indicative of molecular pathology and neuronal damage in neurological diseases.
Magnetic resonance imaging (MRI; namely diffusion tensor imaging, fractional anisotropy, anatomical volume effect map) and nuclear medicine [ie F-18 fluorodeoxyglucose (FDG)-positron emission tomography, single-photon emission computed tomography ( SPECT), a β-amyloid-labeled tracer Pittsburgh Compound B (PIB)] provides researchers with tools to scaffold their existing clinical and pathological knowledge as a sign of dementia. The goals of imaging technology include tracking and staging of disease progression, differential diagnosis, identification of pre-neurodegenerative stages, and detection of comorbid conditions in the elderly, such as idiopathic normal pressure hydrocephalus (INPH). Biomarker testing can identify individuals at risk for dementia, help differential diagnosis, and provide confirmation of molecular pathology and neuronal damage. However, at present, advanced imaging tools and biomarker analysis are mainly used in research, with limited clinical applications.
The pathology of AD, amyloid plaques, and neurofibrillary tangles has an initial affinity for the marginal areas of cognitive processes involved in episodic memory. As the disease progresses, the pathology progresses to other cortical areas, leading to additional recognition Awareness, behavior, and mental symptoms. The latest advances in clinical diagnostic procedures, imaging, and biomarker identification have led to the revision of AD research and clinical diagnostic criteria [14] The revision includes the obvious clinical symptoms of AD and the spectrum of the intermediate stages of the disease, such as asymptomatic individuals and mildly recognized individuals. Identification of positive biomarkers in patients with cognitive impairment (MCI; functional capacity of the disease without significant interruption of focal cognitive changes).
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