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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".
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, clinical research investigators, clinical trial sponsors, and monitors.
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 ...
The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
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; Submission for Institutional Review Board or Independent Ethics Committee (IRB/IEC) approval. In Europe, submission to Ethics Committee is often done by sponsor or by CRO, i.e. not by SMO
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]
One change was that the government named a list of responsibilities and divided among the ethics committee, the investigator, and the sponsor. [53] This way, each of those agents in a clinical trial take responsibility for their parts. [53] From this point the researchers must register all clinical trials into the Clinical Trials Registry ...