{"id":32608,"date":"2023-08-28T11:37:56","date_gmt":"2023-08-28T08:37:56","guid":{"rendered":"https:\/\/crg.global\/?p=32608"},"modified":"2023-09-28T11:42:18","modified_gmt":"2023-09-28T08:42:18","slug":"management-of-trial-master-file","status":"publish","type":"post","link":"https:\/\/crg.global\/uk\/management-of-trial-master-file\/","title":{"rendered":"Management of Trial Master File"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"32608\" class=\"elementor elementor-32608\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4bd248d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4bd248d\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7472c24\" data-id=\"7472c24\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-eb36dbc elementor-widget elementor-widget-image\" data-id=\"eb36dbc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"640\" height=\"427\" src=\"https:\/\/crg.global\/wp-content\/uploads\/2023\/09\/InfoCRG_article_8.jpeg\" class=\"attachment-large size-large wp-image-32610\" alt=\"\" srcset=\"https:\/\/crg.global\/wp-content\/uploads\/2023\/09\/InfoCRG_article_8.jpeg 640w, https:\/\/crg.global\/wp-content\/uploads\/2023\/09\/InfoCRG_article_8-300x200.jpeg 300w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4ab54a8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4ab54a8\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5801500\" data-id=\"5801500\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c2fcb65 elementor-widget elementor-widget-text-editor\" data-id=\"c2fcb65\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h3 id=\"ember35\" class=\"ember-view reader-content-blocks__paragraph\"><strong>Overview<\/strong><\/h3><p id=\"ember36\" class=\"ember-view reader-content-blocks__paragraph\">The vital part of each Clinical Trial conduct is management of Essential Documents.<\/p><p id=\"ember37\" class=\"ember-view reader-content-blocks__paragraph\">According to established Good Clinical Practice (GCP) guidelines \u201cEssential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the Investigator, Sponsor and Monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.\u201d.<\/p><p id=\"ember38\" class=\"ember-view reader-content-blocks__paragraph\">The various Essential Documents are grouped in three sections according to the stage of the Clinical Trial during which they will normally be generated:<\/p><ol><li>before the clinical phase of the trial commences,<\/li><li>during the clinical conduct of the trial, and<\/li><li>after completion or termination of the trial.<\/li><\/ol><p id=\"ember40\" class=\"ember-view reader-content-blocks__paragraph\">GCP provides descriptions of the purpose of each Essential Document, and whether it should be filed in either the Investigator\/Institution or Sponsor files, or both.<\/p><p id=\"ember41\" class=\"ember-view reader-content-blocks__paragraph\">Trial Master Files (either paper or electronic, hereinafter referred to as \u201c(e)TMF\u201d) should be established at the beginning of the trial, both at the Investigator\/Institution\u2019s Site (usually referred to as \u201cInvestigator Site File\u201d) and at the Sponsor&#8217;s office. A final close-out of a trial can only be done when both Investigator\/Institution and Sponsor files are reviewed and it is confirmed that all necessary documents are filed appropriately.<\/p><h3 id=\"ember42\" class=\"ember-view reader-content-blocks__paragraph\"><strong>Aim<\/strong><\/h3><p id=\"ember43\" class=\"ember-view reader-content-blocks__paragraph\">This article aims to briefly describe the management of Trial Master File in Clinical Trials.<\/p><h3 id=\"ember44\" class=\"ember-view reader-content-blocks__paragraph\"><strong>Process<\/strong><\/h3><p id=\"ember45\" class=\"ember-view reader-content-blocks__paragraph\">Essential Documents should be collected and filed in the (e)TMF according to:<\/p><ul><li>GCP<\/li><li>Drug Information Association (DIA) TMF Reference Model<\/li><li>Sponsor\u2019s requirements<\/li><li>Approved TMF Management Plan<\/li><li>Regulatory requirements.<\/li><\/ul><p id=\"ember47\" class=\"ember-view reader-content-blocks__paragraph\">Essential Documents must be provided to the Sponsor and\/or Regulatory Authorities representatives at first request. These documents must be always audit ready and available for review during the Clinical Trial conduct and within the defined by Sponsor\/local Regulatory timelines archiving period.<\/p><p id=\"ember48\" class=\"ember-view reader-content-blocks__paragraph\">The essential role in (e)TMF management of Clinical Trials lies within \u201cTMF Coordinator\u201d job role (at CRG it is a separate role, but in different companies it could be embedded into other clinical trial roles).<\/p><p id=\"ember49\" class=\"ember-view reader-content-blocks__paragraph\">Typical responsibilities of TMF Coordinator are:<\/p><ul><li>Collection of Essential Documents for (e)TMF from Project Team members<\/li><li>Renaming of Essential Documents according to TMF Naming Conventions specified in corresponding TMF Management Plan<\/li><li>Timely submission of collected Essential Documents to (e)TMF:<\/li><\/ul><ol><li>by directly uploading them to electronic TMF or filing them to paper TMF<\/li><li>by separately sending them to the Sponsor\/TPV\u2019s TMF Specialist via previously approved TMF distribution list of e-mails\/mailing addresses along with the corresponding completed transmittal forms.<\/li><\/ol><p id=\"ember52\" class=\"ember-view reader-content-blocks__paragraph\">In execution of the above responsibilities TMF Coordinator (blinded or unblinded, if applicable) closely cooperates with the rest of CRG Project Team.<\/p><p>\u00a0<\/p><p id=\"ember54\" class=\"ember-view reader-content-blocks__paragraph\"><span style=\"text-decoration: underline;\"><span class=\"tvm__text--legacy-publishing-emphasis\">(e)TMF Structure<\/span><\/span><\/p><p id=\"ember55\" class=\"ember-view reader-content-blocks__paragraph\">Usually, the (e)TMF consists of the Trial File, Country File and Site Files:<\/p><ul><li>Trial File \u2013 documentation applicable to the trial level<\/li><li>Country File \u2013 documentation applicable to the country level (in case more than one country participate in the Clinical Trial)<\/li><li>Site File \u2013 documentation applicable to the site level, including Pharmacy File, if applicable.<\/li><\/ul><p id=\"ember57\" class=\"ember-view reader-content-blocks__paragraph\">The TMF Index is usually based on the DIA TMF Reference Model (version is agreed on a project-by-project basis). It is used to transmit final documents to their appropriate filing location and contains relevant information about TMF expectations for the Clinical Trial.<\/p><p id=\"ember58\" class=\"ember-view reader-content-blocks__paragraph\">TMF Index according to the DIA TMF Reference Model is broken into several sections: Trial Management, Central Trial Documents, Regulatory, Investigational Review Board\/Independent Ethics Committee and other Approvals, Site Management, Investigational Medicinal Product and Trial Supplies, Safety Reporting, Centralized Testing, Third Parties, Data Management, Statistics.<\/p><p id=\"ember59\" class=\"ember-view reader-content-blocks__paragraph\">Depending on the activities being carried out, many Clinical Trials require additional documents not specifically mentioned, therefore the additional sections as part of the TMF Index might be included that will facilitate reconstructing and evaluating of the clinical trial conduct.<\/p><p id=\"ember61\" class=\"ember-view reader-content-blocks__paragraph\"><span style=\"text-decoration: underline;\"><span class=\"tvm__text--legacy-publishing-emphasis\">Filing of documents into (e)TMF<\/span><\/span><\/p><p id=\"ember62\" class=\"ember-view reader-content-blocks__paragraph\">All responsible Clinical Trial Project Team members are required to ensure that the Essential Documents are submitted\/uploaded to (e)TMF in a timely manner.<\/p><p id=\"ember63\" class=\"ember-view reader-content-blocks__paragraph\">Essential Documents filed into (e)TMF should be checked prior to submission\/uploading by applicable Project Team members, so they satisfy Good Documentation Practices.<\/p><p id=\"ember64\" class=\"ember-view reader-content-blocks__paragraph\">Essential Documents should be checked against the next parameters (non-exhaustive list):<\/p><ul><li>Documents titled in compliance with the requirements of approved TMF Naming Conventions<\/li><li>Version of document in line with the related SOPs\/Work Instructions\/Clinical Study Project Plans\/applicable templates<\/li><li>Document format \u2013 PDF is preferred document format for electronic TMF upload<\/li><li>Document included in the correct section in a Transmittal Form for electronic TMF upload (if applicable)<\/li><li>Originals or Certified Copies<\/li><li>Translations if required and availability of corresponding Certificate of Translation Accuracy.<\/li><\/ul><p id=\"ember66\" class=\"ember-view reader-content-blocks__paragraph\">When a certain document is missing or is incomplete a \u201cNote to File\u201d Form should be completed, dated, and signed by the responsible Project Team member.\u00a0Its purpose is to explain clearly and explicitly the reason of why the document is missing or is incomplete. It should be filed in (e)TMF replacing the missing document or clarifying any document-related issue(s).<\/p><p id=\"ember67\" class=\"ember-view reader-content-blocks__paragraph\">\u00a0<\/p><p id=\"ember68\" class=\"ember-view reader-content-blocks__paragraph\"><span style=\"text-decoration: underline;\"><span class=\"tvm__text--legacy-publishing-emphasis\">Unblinded (e)TMF management<\/span><\/span><\/p><p id=\"ember69\" class=\"ember-view reader-content-blocks__paragraph\">In case the Clinical Trial consists of blinded and unblinded components, at the beginning of the Clinical Trial unblinded Project Team is assigned. Unblinded Project Team is responsible to manage unblinded Essential Documents (these are usually related to Investigational Medicinal Products) and their filing to unblinded (e)TMF. Unblinded Essential Documents are located in corresponding Pharmacy File at Clinical Trial Sites.\u00a0<\/p><p id=\"ember70\" class=\"ember-view reader-content-blocks__paragraph\">Unblinded Essential Documents are managed only by unblinded Project and Site Teams similarly to blinded Essential Documents and this should be clearly reflected in TMF Management Plan.<\/p><p id=\"ember71\" class=\"ember-view reader-content-blocks__paragraph\">\u00a0<\/p><p id=\"ember72\" class=\"ember-view reader-content-blocks__paragraph\"><span style=\"text-decoration: underline;\"><span class=\"tvm__text--legacy-publishing-emphasis\">(e)TMF retention and archiving<\/span><\/span><\/p><p id=\"ember73\" class=\"ember-view reader-content-blocks__paragraph\">The retention and\/or destruction procedures will be agreed with the Sponsor or applicable Third Party Vendor and described in corresponding TMF Management Plan. The retention period is to be adhered to and in accordance with the current country laws and regulations.<\/p><p id=\"ember74\" class=\"ember-view reader-content-blocks__paragraph\">\u00a0<\/p><h3 id=\"ember75\" class=\"ember-view reader-content-blocks__paragraph\"><strong>Carpathian Research Group capabilities<\/strong><\/h3><p id=\"ember76\" class=\"ember-view reader-content-blocks__paragraph\">CRG as a CRO has extensive experience in management of (e)TMF and with our expertise Sponsors could be confident on (e)TMF inspection\/audit readiness at any moment of Clinical Trial lifecycle.<\/p><p id=\"ember77\" class=\"ember-view reader-content-blocks__paragraph\">Information on all other Clinical Trial services that we provide could be found at\u00a0<a href=\"https:\/\/crg.global\/uk\/\">www.crg.global<\/a><\/p><p id=\"ember78\" class=\"ember-view reader-content-blocks__paragraph\">You can contact us at\u00a0<a href=\"http:\/\/mailto:info@crg.global\/uk\/\">info@crg.global<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Overview The vital part of each Clinical Trial conduct is management of Essential Documents. According to established Good Clinical Practice (GCP) guidelines \u201cEssential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"ocean_post_layout":"","ocean_both_sidebars_style":"","ocean_both_sidebars_content_width":0,"ocean_both_sidebars_sidebars_width":0,"ocean_sidebar":"0","ocean_second_sidebar":"0","ocean_disable_margins":"enable","ocean_add_body_class":"","ocean_shortcode_before_top_bar":"","ocean_shortcode_after_top_bar":"","ocean_shortcode_before_header":"","ocean_shortcode_after_header":"","ocean_has_shortcode":"","ocean_shortcode_after_title":"","ocean_shortcode_before_footer_widgets":"","ocean_shortcode_after_footer_widgets":"","ocean_shortcode_before_footer_bottom":"","ocean_shortcode_after_footer_bottom":"","ocean_display_top_bar":"default","ocean_display_header":"default","ocean_header_style":"","ocean_center_header_left_menu":"0","ocean_custom_header_template":"0","ocean_custom_logo":0,"ocean_custom_retina_logo":0,"ocean_custom_logo_max_width":0,"ocean_custom_logo_tablet_max_width":0,"ocean_custom_logo_mobile_max_width":0,"ocean_custom_logo_max_height":0,"ocean_custom_logo_tablet_max_height":0,"ocean_custom_logo_mobile_max_height":0,"ocean_header_custom_menu":"0","ocean_menu_typo_font_family":"0","ocean_menu_typo_font_subset":"","ocean_menu_typo_font_size":0,"ocean_menu_typo_font_size_tablet":0,"ocean_menu_typo_font_size_mobile":0,"ocean_menu_typo_font_size_unit":"px","ocean_menu_typo_font_weight":"","ocean_menu_typo_font_weight_tablet":"","ocean_menu_typo_font_weight_mobile":"","ocean_menu_typo_transform":"","ocean_menu_typo_transform_tablet":"","ocean_menu_typo_transform_mobile":"","ocean_menu_typo_line_height":0,"ocean_menu_typo_line_height_tablet":0,"ocean_menu_typo_line_height_mobile":0,"ocean_menu_typo_line_height_unit":"","ocean_menu_typo_spacing":0,"ocean_menu_typo_spacing_tablet":0,"ocean_menu_typo_spacing_mobile":0,"ocean_menu_typo_spacing_unit":"","ocean_menu_link_color":"","ocean_menu_link_color_hover":"","ocean_menu_link_color_active":"","ocean_menu_link_background":"","ocean_menu_link_hover_background":"","ocean_menu_link_active_background":"","ocean_menu_social_links_bg":"","ocean_menu_social_hover_links_bg":"","ocean_menu_social_links_color":"","ocean_menu_social_hover_links_color":"","ocean_disable_title":"default","ocean_disable_heading":"default","ocean_post_title":"","ocean_post_subheading":"","ocean_post_title_style":"","ocean_post_title_background_color":"","ocean_post_title_background":0,"ocean_post_title_bg_image_position":"","ocean_post_title_bg_image_attachment":"","ocean_post_title_bg_image_repeat":"","ocean_post_title_bg_image_size":"","ocean_post_title_height":0,"ocean_post_title_bg_overlay":0.5,"ocean_post_title_bg_overlay_color":"","ocean_disable_breadcrumbs":"default","ocean_breadcrumbs_color":"","ocean_breadcrumbs_separator_color":"","ocean_breadcrumbs_links_color":"","ocean_breadcrumbs_links_hover_color":"","ocean_display_footer_widgets":"default","ocean_display_footer_bottom":"default","ocean_custom_footer_template":"0","ocean_post_oembed":"","ocean_post_self_hosted_media":"","ocean_post_video_embed":"","ocean_link_format":"","ocean_link_format_target":"self","ocean_quote_format":"","ocean_quote_format_link":"post","ocean_gallery_link_images":"off","ocean_gallery_id":[],"footnotes":""},"categories":[1],"tags":[],"class_list":["post-32608","post","type-post","status-publish","format-standard","hentry","category-infocrg","entry"],"_links":{"self":[{"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/posts\/32608","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/comments?post=32608"}],"version-history":[{"count":4,"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/posts\/32608\/revisions"}],"predecessor-version":[{"id":32613,"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/posts\/32608\/revisions\/32613"}],"wp:attachment":[{"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/media?parent=32608"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/categories?post=32608"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/crg.global\/uk\/wp-json\/wp\/v2\/tags?post=32608"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}