{"id":12931,"date":"2021-02-24T02:35:00","date_gmt":"2021-02-24T07:35:00","guid":{"rendered":"https:\/\/en.ennov.com\/?p=12931"},"modified":"2022-05-23T02:30:58","modified_gmt":"2022-05-23T07:30:58","slug":"mhra-trial-master-file-tmf-gcp-inspection","status":"publish","type":"post","link":"https:\/\/dqdev.co\/ennov\/blog\/clinical-blog\/mhra-trial-master-file-tmf-gcp-inspection\/","title":{"rendered":"MHRA Trial Master File (TMF) GCP Inspection Findings: Trends and Takeaways"},"content":{"rendered":"\n<p>On February 12, 2021, The UK Medicines &amp; Healthcare Products Regulatory Agency (MHRA) published their annual <a href=\"https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/961531\/GCP_INSPECTIONS_METRICS_2018-2019_final_12-02-21.pdf\"><strong>GCP Inspections Metrics Report<\/strong><\/a><strong>. <\/strong>This report covered the period from 1 April 2018 to 31 March 2019.<\/p>\n\n\n\n<p>For an in-depth review on this topic, check out the industry brief: <strong><a href=\"https:\/\/en.ennov.com\/insider\/clinical\/industry-brief-mhra-tmf-checklist\/\">MHRA TMF Inspection Finding Review Checklist<\/a> <\/strong>available for free on <a href=\"https:\/\/en.ennov.com\/insider\/\"><strong>Ennov Insider<\/strong><\/a>. <\/p>\n\n\n\n<p>The report provides excellent insight into MHRA\u2019s compliance concerns.&nbsp; In this edition, there were a number of detailed findings related to the Trial Master File.<\/p>\n\n\n\n<p>The report includes findings in 3 categories:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Sponsor: 8 inspections, 4 with at least one critical finding, and 7 total critical findings<strong>.&nbsp; 2 of these were directly related to the Trial Master File. <\/strong>For one sponsor, this was a major finding at the previous inspection of this organisation and was therefore escalated to a critical finding<\/li><li>CRO: 11 inspections, 4 with at least one critical finding, and 6 total critical findings.&nbsp; 1 <strong>of these was directly related to the Trial Master File.<\/strong><\/li><li>Non-Commercial Entity: 11 inspections, 2 with at least one critical finding, and 3 total critical findings. <strong>1 of these was indirectly related to the Trial Master File.<\/strong><\/li><\/ul>\n\n\n\n<p>TMF-related observations were also common beyond critical findings.&nbsp; Although MHRA does not provide details, Record Keeping\/Essential Documents was actually the most common area of findings, accounting for about 18% of all total findings for sponsor inspections.<\/p>\n\n\n\n<p>The report contained a total of 33 individual observations related to eTMF.&nbsp; When the observations were categorized, a number of trends emerged, which are summarized below (showing only observations that occurred more than once).<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"600\" height=\"224\" src=\"https:\/\/en.ennov.com\/wp-content\/uploads\/2021\/03\/MHRA-TMF-Finding-Trends.png\" alt=\"\" class=\"wp-image-12995\"\/><\/figure>\n\n\n\n<p>Some important trends include:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>TMF Completeness<\/strong>.&nbsp; Numerous observations related to the completeness of the TMF.&nbsp; In some cases, completeness was lacking because the scope of the TMF did not include all essential documents, especially if not stored in the core eTMF.&nbsp; Other observations could be traced to failure to file required documents and lack of oversight in including completeness.&nbsp; TMF completeness issues are not new or suppressing, but show that some organizations are not taking action based on previous years\u2019 observations.<\/li><li><strong>Ancillary Systems<\/strong>.&nbsp; This area showed increased focus by MHRA.&nbsp; Observations included failure to define ancillary systems as containing TMF content, lack of control and oversight, and failure to define the system of record in TMF SOPs and indices.&nbsp; As a result, this area is tightly coupled with completeness issues.<\/li><li><strong>Naming Conventions<\/strong>.&nbsp; Inspectors should be able to rely on consistent naming conventions to identify documents and understand their contents without having to open documents.<\/li><\/ul>\n\n\n\n<p>For a complete analysis and a set of recommended review actions, see Ennov\u2019s industry brief: <strong><a href=\"https:\/\/en.ennov.com\/insider\/clinical\/industry-brief-mhra-tmf-checklist\/\">MHRA TMF Inspection Finding Review Checklist<\/a> <\/strong>available on <a href=\"https:\/\/en.ennov.com\/insider\/\"><strong>Ennov Insider<\/strong><\/a>. If you\u2019re not already a member, join today for free access to a useful set of white papers, videos and other resources.<\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On February 12, 2021, The UK Medicines &amp; Healthcare Products Regulatory Agency (MHRA) published their annual GCP Inspections Metrics Report. This report covered the period from 1 April 2018 to 31 March 2019. For an in-depth review on this topic, check out the industry brief: MHRA TMF Inspection Finding Review Checklist available for free on [&hellip;]<\/p>\n","protected":false},"author":232,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"categories":[150],"tags":[],"type_content":[],"job":[],"employees_type":[],"class_list":["post-12931","post","type-post","status-publish","format-standard","hentry","category-clinical-blog","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v19.2.1 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>MHRA Trial Master File (TMF) GCP Inspection Findings and Trends<\/title>\n<meta name=\"description\" content=\"The report provides excellent insight into MHRA\u2019s compliance concerns; a number of detailed findings related to the Trial Master File.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MHRA Trial Master File (TMF) GCP Inspection Findings: Trends and Takeaways\" \/>\n<meta property=\"og:description\" content=\"The report provides excellent insight into MHRA\u2019s compliance concerns; 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