TRIAL MASTER FILE
https://search.headlines-world.com/search.html?q=TRIAL%20MASTER%20FILEGo
Filing (law)In law, filing is the delivery of a document to the clerk of a court and the acceptance of the document by the clerk for placement into the official record. If a document is delivered to the clerk and is temporarily placed or deposited with the court (but is not accepted for filing), it is said to have been lodged with or received by the court (but not filed). Courts will not consider motions unless an appropriate memorandum or brief is filed before the appropriate deadline. Usually a filing fee is paid which is part of court costs.
In connection with: Filing (law)
Title combos: law Filing
Description combos: law will the document official filed with said acceptance
Good Clinical Practice DirectiveThe Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. The directive deals with the following items: Good clinical practice for the design, conduct, recording and reporting of clinical trials: Good Clinical Practice (GCP) The Ethics Committee The sponsors Investigator's Brochure Manufacturing or import authorisation Exemption for Hospital & Health Centres and Reconstitution Conditions of Holding a Manufacturing Licence The Trial master file and archiving Format of Trial Master File Retention of Essential and Medical Records Inspectors Inspection procedures Final provisions
In connection with: Good Clinical Practice Directive
Title combos: Directive Practice Practice Clinical Good Good Clinical Practice Directive
Description combos: Investigator Exemption 2005 design reporting design as and the
Mystery Case FilesMystery Case Files is a video game series originally developed by the internal studios of Big Fish Games. Sequels were then developed by Elephant Games between 2013 and 2014 and Eipix Entertainment between 2015 and 2019. The newest installments have been developed by GrandMA Studios since 2020. The Mystery Case Files series is known for its hidden object puzzles where, in order to progress through a game, the player plays the role of a Master Detective and must find a certain number of items hidden somewhere on a painted scene. In 2007, Big Fish Games estimated that "100 million people have at least sampled trial versions" of the Mystery Case Files games since the initial launch of Mystery Case Files: Huntsville. The latest installment in the series, Mystery Case Files: The Riddle of Mrs. Bishop, was released on November 26, 2024, and is the 27th game in the series.
In connection with: Mystery Case Files
Title combos: Mystery Case Files Case Mystery
Description combos: November by have series number Files find at of
EPharmaSolutionsePharmaSolutions (ePS), as a contract research organization, is an American clinical research provider. The solutions include proprietary software applications and global clinical services that focus on the major areas of clinical study delays. ePS was founded in 2001 by Lance Converse and is headquartered in Plymouth Meeting, Pennsylvania, employing 60+ clinical researchers and technologists. ePharmaSolutions' Clinical Trial Portal technology won the 2009 and 2013 Bio-IT World for “Best in Class Clinical Trial Technology” and the 2013 Microsoft Lifesciences Innovation Award making it the most widely used Clinical Trial Portal and Electronic Trial Master File solution in the pharmaceutical industry with over 350,000 users in 130 countries. 1Bio-IT World - July 2009 [1]
In connection with: EPharmaSolutions
Description combos: of Bio services is Clinical that widely ePharmaSolutions Trial
Trial master fileIn order to comply with government regulatory requirements pertinent to clinical trials, every organization involved in clinical trials must maintain and store certain documents, images and content related to the clinical trial. Depending on the regulatory jurisdiction, this information may be stored in the trial master file or TMF, which today takes the form of an electronic trial master file (eTMF). The International Conference on Harmonization (ICH) published a consolidated guidance for industry on Good Clinical Practice in 1996 with the objective of providing a unified standard for the European Union, Japan, and the United States of America to facilitate mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. This guidance document established the requirement across all ICH regions to establish trial master files containing essential documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.[2] In some jurisdictions, for example the USA, there is no specific requirement for a trial master file. However, if the regulatory authority requires ICH GCP to be followed, then there is consequently a requirement to create and maintain a trial master file.[2]
In connection with: Trial master file
Title combos: Trial master Trial master file
Description combos: acceptance followed form providing every or jurisdictions that GCP
Electronic trial master fileAn 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. The term eTMF encompasses strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content. An eTMF system consists of software and hardware that facilitates the management of regulated clinical trial content. Regulatory agencies have outlined the required components of eTMF systems that use electronic means to store the content of a clinical trial, requiring that they include: Digital content archiving, security and access control, change controls, audit trails, and system validation.
In connection with: Electronic trial master file
Title combos: Electronic trial file master trial Electronic master file trial
Description combos: of and the clinical electronic other of means trial
Trial of Alex MurdaughState of South Carolina v. Richard Alexander Murdaugh was the trial of American former lawyer Alex Murdaugh for the murder of his wife, Maggie, and their 22-year-old son, Paul, on June 7, 2021. The trial in the fourteenth circuit of the South Carolina Circuit Court began on January 25, 2023, and ended on March 2 with a guilty verdict on all four counts. Murdaugh, who had pleaded not guilty, was sentenced to two life sentences to run consecutively without the possibility of parole. He soon filed a motion for new trial, alleging that the court clerk tampered with the jury; a new trial court judge denied the motion in January 2024. Local media called the trial South Carolina's "trial of the century" and "one of the most high-profile and sensational cases in South Carolina legal history." On May 14, 2025, former trial clerk Becky Hill was arrested and charged with felony misconduct; this was seen as reviving if not increasing Murdaugh's efforts to obtain a new trial.
In connection with: Trial of Alex Murdaugh
Title combos: Alex of of Murdaugh Trial Trial Alex Murdaugh of
Description combos: efforts seen all fourteenth son tampered the Alexander South
Quick Access
Tag Explorer
Discover Fresh Ideas in the Universe of aéPiot
MultiSearch | Search | Tag Explorer
SHEET MUSIC | DIGITAL DOWNLOADS