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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.
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.
Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. [1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and ...
The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s). (ICH E6) Multicenter study. A clinical trial that is carried out at more than one medical institution. (NCI)
The Clinical Trials Facilitation Group (CTFG) of the Heads of Medicines Agency issued a Q&A document in 2017 addressing Good Laboratory Practice (GLP) requirements within the context of clinical trials for human medicines. This document aims to provide clarification and guidance on GLP principles applicable to non-clinical safety studies ...
A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. [1] SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.
A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by research staff to monitor their health and to determine the safety and effectiveness of their treatment.
By law CPRIT was established to: "(1) create and expedite innovation in the area of cancer research and in enhancing the potential for a medical or scientific breakthrough in the prevention of cancer and cures for cancer;(2) attract, create, or expand research capabilities of public or private institutions of higher education and other public ...