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It concluded disclosure requirements fell short of what is required and proposed more comprehensive data collections. [ 11 ] In The Netherlands the Transparantieregister Zorg was founded in 2013, that requires full disclosure of payments above 500 euro from pharmaceutical companies and manufacturers of medical devices to healthcare workers ...
50 Protection of human subjects in clinical trials; 54 Financial disclosure by clinical investigators [2] 56 Institutional review boards that oversee clinical trials; 58 Good laboratory practices (GLP) for nonclinical studies; The 100 series are regulations pertaining to food: 101, especially 101.9 — Nutrition facts label related
In a clinical trial involving human subjects, a set of content known as a trial master file (TMF) must be produced in accordance with applicable international and local regulations. TMFs are a collection of documents and other artifacts which "individually and collectively permit evaluation of the conduct of a trial and the quality of the data ...
Florida Department of Financial Services (FLDFS) is a state agency of Florida. Its headquarters are in Tallahassee . [ 1 ] In 2002 the Florida Legislature merged the Department of Insurance, Treasury and State Fire Marshal and the Department of Banking and Finance into one department, the Florida Department of Financial Services.
The disclosure statement is called an offering circular, which contains a balance sheet from at most 90 days before the file date, two years of income statements, cash flow information, and shareholder equity reports. Regulation A does not specify purchaser number, sophistication, or resale requirements.
IFRS 7, titled Financial Instruments: Disclosures, is an International Financial Reporting Standard (IFRS) published by the International Accounting Standards Board (IASB). It requires entities to provide certain disclosures regarding financial instruments in their financial statements. [ 1 ]
The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to clinical trials services as: [8]: 10 "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or ...
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.