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Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. GCP guidelines [1] include protection of human rights for the subjects and volunteers in a clinical trial. It also ...
A Site Management Organization (SMO) is an organization that provides clinical trial-related services to a contract research organization (CRO), a pharmaceutical company, a biotechnology company, a medical device company, or a clinical site.
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).
DCSA Industrial Security Representatives, Counterintelligence Agents, Background Investigators, and Information System Security Professionals are credentialed Special Agents. DCSA also uses a number of contract investigators and staff to help support DCSA's various missions.
The Office of Administration and Policy (OAP) recommends national policy on issues pertaining to enforcement and compliance. OAP provides a range of administrative support services which includes: human resources, labor relations, budget, finances, contracts, grants, records management and management of the compliance and enforcement information on the Agency's website.
In many countries, the term principal investigator (PI) refers to the holder of an independent grant and the lead researcher for the grant project, usually in the sciences, such as a laboratory study or a clinical trial. The phrase is also often used as a synonym for "head of the laboratory" or "research group leader".
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]
In July 2013, Serco Inc. (the North American division of Serco Group) was awarded a US$1.25 billion contract from the Centers for Medicare and Medicaid Services (a division of the Department of Health and Human Services (HHS) to provide Eligibility Support Services (i.e., the “CMS-ESS” contract), in support of the Patient Protection and ...