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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.
Director of Cost Assessment & Program Evaluation: Christine H. Fox: October 28, 2009 – June 2013 Robert M. Gates Leon Panetta Chuck Hagel. Barack Obama Jamie M. Morin: June 30, 2014 – January 20, 2017 Chuck Hagel Ashton Carter. Barack Obama Scott Comes (Acting) January 20, 2017 - August 7, 2017 James Mattis: Donald Trump: Robert Daigle
A cost estimate is the approximation of the cost of a program, project, or operation. The cost estimate is the product of the cost estimating process. The cost estimate has a single total value and may have identifiable component values. A problem with a cost overrun can be avoided with a credible, reliable, and accurate cost estimate. A cost ...
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 pivot table in BOEMax, a Basis of Estimate software package. To create a BOE companies, throughout the past few decades, have used spreadsheet programs and skilled cost analysts to enter thousands of lines of data and create complex algorithms to calculate the costs. These positions require a high level of skill to ensure accuracy and ...
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]