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The National Health and Medical Research Council (NHMRC) is the main statutory authority of the Australian Government responsible for medical research. It was the eighth largest research funding body in the world in 2016, [ 1 ] and NHMRC-funded research is globally recognised for its high quality. [ 2 ]
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
Some grants are specified for "new investigators", which is defined as someone who has not received a prior NIH grant other than a career award or specific small grants (R15, R21, R56, etc.). An "early stage investigator" is someone who has received their PhD or MD or has finished residency within the past 10 years. [5]
United States: Although ICH GCP guidelines are recommended by the Food and Drug Administration (FDA), [4] they are not statutory in the United States. The National Institutes of Health requires NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be ...
Grant management software is a program or application that helps non-profits administer the grant process. Some software is designed to help foundations (known as "grantmakers") to organize, prioritize, and process the grant applications they receive from charities (known as "grantseekers"), as well as simplify oversight of the grants they make.
These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements." [1] Historically, TMFs have been paper-based content sets stored in physical file cabinets, central file rooms, or shelved in binders. The size and complexity ...
Challenge grants are funds disbursed by one party (the grant maker), usually a government agency, corporation, foundation or trust (sometimes anonymously), typically to a non-profit entity or educational institution (the grantee) upon completion of the challenge requirement(s).
The main product of the CONSORT Group is the CONSORT Statement, [1] which is an evidence-based, minimum set of recommendations for reporting randomized trials.It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, reducing the influence of bias on their results, and aiding their critical appraisal and interpretation.