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GCP guidelines [1] include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards ...
The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the department, mostly through the National Institutes of Health (NIH).
The TMF contains the trial sponsor’s and participating investigators’ set of content which individually and collectively permit the evaluation of the conduct of a clinical trial and the quality of the data produced. These documents serve to demonstrate compliance with the standards of GCP and with all applicable regulatory requirements. [1]
The National Safety and Quality Health Service Standards (NSQHS Standards) are Australia's principal health care standards, and apply to all health services including inpatient, outpatient, and community care. [5] There are 8 standards: Clinical governance; Partnering with consumers; Preventing and controlling infections; Medication safety
The site is usually a hospital or a similar health care institution that has adequate infrastructure and staff to meet the requirements of the clinical trial protocol. The scope of an SMO's responsibility is limited to the site and hence the eponymous title. Some (but not all) of the responsibilities include: Contract
AQSIQ directly administers provincial Entry-Exit Inspection and Quarantine Bureaus and Bureaus of Quality and Technical Supervision. [1] For example, the Beijing Entry-Exit Inspection and Quarantine Bureau is responsible for collecting health declaration forms, and used thermal imaging to spot passengers with fever due to the 2009 flu pandemic ...
The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. [1]
Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial.Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) [1] and the World Health Organization (WHO), [2] require data and safety monitoring protocols for Phase I and II clinical trials ...