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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:
An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial. An IB may introduce key aspects and safety measures of a clinical trial protocol, such as: Dose (of the study drug) Frequency of dosing interval; Methods of administration; Safety monitoring ...
The conduct and on-going review is designed to be proportional to the risk of the trial. Typically this role is filled by a Data and Safety Committee, an externally appointed Medical Safety Monitor, [91] an Independent Safety Officer, or for small or low-risk studies the principal investigator. [92]
The May 2020 exam cost each applicant $2,980 ($2,780 exam fee with an additional $200 account fee). [10] According to publicly available financial information on the MCC website, the organization was audited by Deloitte in 2019.
The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. (ICH E6) An individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject.
A research assistant (RA) is a researcher employed, often on a temporary contract, [1] by a university, research institute, or privately held organization to provide assistance in academic or private research endeavors.