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In 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 ...
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.
Data for the submission must include those from one or more rigorous clinical trials. [5] Due to the plural "adequate and well-controlled investigations" in the statute, FDA has interpreted the substantial evidence requirement as requiring at least two adequate and well-controlled clinical trials, each convincing on its own.
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
CPMP/EWP/1776/99: Missing data in confirmatory clinical trials [21] (EMA) explains how the presence of missing data in confirmatory clinical trials should be addressed and reported in a dossier submitted for regulatory review. It provides an insight into the regulatory standards that will be used to assess confirmatory clinical trials with ...
Clinical – efficacy and safety (clinical trials) Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements.
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
Most of the Chapter I regulations are based on the Federal Food, Drug, and Cosmetic Act. Notable sections: 11 — electronic records and electronic signature related; 50 Protection of human subjects in clinical trials; 54 Financial disclosure by clinical investigators [2] 56 Institutional review boards that oversee clinical trials