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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.
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice [1] (GCP) under the auspices of a Principal Investigator (PI). Good clinical practices principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health Science Center at Houston [2] as:
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 ...
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 Department of Defense Inspector General was established in 1982. The mission of DoD IG; as established by the Inspector General Act of 1978, as amended, (5 U.S.C. Appendix); and implemented by DoD Directive 5106.01, "Inspector General of the Department of Defense", is to serve as an independent and objective office in DoD to:
The United States Government Accountability Office (GAO) is an independent, nonpartisan government agency within the legislative branch that provides auditing, evaluative, and investigative services for the United States Congress. [2] It is the supreme audit institution of the federal government of the United States.
Office of Evaluation and Inspections (OEI). OEI conducts national evaluations to provide HHS, Congress, and the public with timely and reliable information on significant issues. In FY 2020, OIG produced 44 evaluations. Office of Investigations (OI). OI conducts criminal, civil, and administrative investigations of fraud and misconduct related ...