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The scope of metadata within the model was also extended in v2.0 to include the trial process with which each TMF artifact is associated. In June 2015 v3.0 [3] of the TMF Reference Model was published. v3.0 includes provision for sub-classification of artifacts; identified as sub-artifacts. Section 01.03 (Trial Committees) was revised to ...
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.
Regulatory regimes vary by country and industry. In the most light-touch forms of regulation, regulatory agencies are typically charged with overseeing a defined industry. Usually they will have two general tasks: [3] [4] [5] creating, reviewing and amending standards expected of individuals and organisations within the industry.
Regulatory risk differentiation is also referred to as the Compliance Model in some regulatory agencies. [1] See for example the Australian Prudential Regulatory Authority risk differentiation approach known as: PAIRS [2] / SOARS. [3] PAIRS is the Probability And Impact Rating System, while SOARS is the Supervisory Oversight And Response System.
In process improvement, SIPOC or suppliers, inputs, process, outputs and customers (sometimes in the reversed order: COPIS) is a tool that summarizes the inputs and outputs of one or more business processes in table form, with each of the words forming a column in the table used in the analysis.
Once-in-a-lifetime memories can be made at these amazing aquariums across the US
This potentially fatal condition gets its name from the molecule galactose-α-1,3-galactose (a.k.a. alpha-gal), which is found in most mammals. People with AGS can develop symptoms after they eat ...
On a global level, researchers found that 2.2 million new cases of type 2 diabetes and 1.2 million new cases of heart disease in 2020 were attributable to SSBs—representing about 1 in 10 new ...