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The Clinical and Laboratory Standards Institute (CLSI) is a volunteer-driven, membership-supported, not-for-profit, standards development organization. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.
WHO Good Clinical Laboratory Practice (GCLP) ISBN 978-92-4-159785-2; Stevens W. (2003) Good Clinical Laboratory Practice (GCLP): The need for a hybrid of Good Laboratory Practice and Good Clinical Practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. Quality Assurance, 10: 83–89.
Clinical laboratories in the US that perform high complexity testing require a high complexity laboratory director (HCLD) that has earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS.
The Declaration of Helsinki (DoH, Finnish: Helsingin julistus) is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). [1] It is widely regarded as the cornerstone document on human research ethics. [1] [2] [3] [4]
CDRH intends to enroll more innovators and their devices across a broader range of clinical disciplines, with a goal of enrolling up to 325 by 2027. The use of peer-reviewed Regulatory Science Tools (RSTs) [26] allows innovators to efficiently navigate the design and redesign loop and expedite medical device innovation. The tools include ...
Other general rules, such as the regulations for clinical trials involving human subjects in 21CFR50, may also apply. [citation needed] In addition to these laws and guidelines, CBER also publishes guidance documents. These are not requirements, but are generally followed by industry.
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
Clinical pathology is a medical specialty that is concerned with the diagnosis of disease based on the laboratory analysis of bodily fluids, such as blood, urine, and tissue homogenates or extracts using the tools of chemistry, microbiology, hematology, molecular pathology, and Immunohaematology.