Matches in DBpedia 2016-04 for { <http://dbpedia.org/resource/Trial_master_file> ?p ?o }
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- Trial_master_file abstract "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. 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]".
- Trial_master_file wikiPageExternalLink www.ich.org.
- Trial_master_file wikiPageExternalLink carelex-builds-support-for-interoperability-standard-for-clinical-trial-data-exchange.
- Trial_master_file wikiPageExternalLink etmf-standards.
- Trial_master_file wikiPageExternalLink 3cc1aen_en.pdf.
- Trial_master_file wikiPageExternalLink resources.
- Trial_master_file wikiPageExternalLink LexUriServ.do?uri=OJ:L:2005:091:0013:0019:en:PDF.
- Trial_master_file wikiPageExternalLink ?uri=uriserv:OJ.L_.2014.158.01.0001.01.ENG.
- Trial_master_file wikiPageExternalLink etmf.
- Trial_master_file wikiPageExternalLink www.etmf.org.
- Trial_master_file wikiPageExternalLink EDM-Corner.aspx.
- Trial_master_file wikiPageExternalLink WC500138893.pdf.
- Trial_master_file wikiPageExternalLink www.etmf.org.
- Trial_master_file wikiPageExternalLink UCM336889.pdf.
- Trial_master_file wikiPageID "32783457".
- Trial_master_file wikiPageLength "17829".
- Trial_master_file wikiPageOutDegree "13".
- Trial_master_file wikiPageRevisionID "676067375".
- Trial_master_file wikiPageWikiLink Category:Clinical_trials.
- Trial_master_file wikiPageWikiLink Controlled_vocabulary.
- Trial_master_file wikiPageWikiLink Database.
- Trial_master_file wikiPageWikiLink File_system.
- Trial_master_file wikiPageWikiLink Good_clinical_practice.
- Trial_master_file wikiPageWikiLink Metadata.
- Trial_master_file wikiPageWikiLink World_Wide_Web_Consortium.
- Trial_master_file wikiPageWikiLinkText "Trial master file".
- Trial_master_file wikiPageWikiLinkText "trial master file and archiving".
- Trial_master_file wikiPageUsesTemplate Template:Citation_needed.
- Trial_master_file wikiPageUsesTemplate Template:Orphan.
- Trial_master_file wikiPageUsesTemplate Template:Reflist.
- Trial_master_file subject Category:Clinical_trials.
- Trial_master_file type Trial.
- Trial_master_file comment "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.".
- Trial_master_file label "Trial master file".
- Trial_master_file sameAs Q7839969.
- Trial_master_file sameAs Trial_Master_File.
- Trial_master_file sameAs m.0h3t_4h.
- Trial_master_file sameAs Q7839969.
- Trial_master_file wasDerivedFrom Trial_master_file?oldid=676067375.
- Trial_master_file isPrimaryTopicOf Trial_master_file.