{"id":68213,"date":"2021-03-08T12:28:32","date_gmt":"2021-03-08T17:28:32","guid":{"rendered":"https:\/\/www.imperialcrs.com\/blog\/?p=68213"},"modified":"2023-12-09T05:03:28","modified_gmt":"2023-12-09T05:03:28","slug":"how-to-take-the-pain-out-of-study-archiving","status":"publish","type":"post","link":"https:\/\/www.imperialcrs.com\/blog\/imperial-graphics\/how-to-take-the-pain-out-of-study-archiving\/","title":{"rendered":"How to Take the Pain Out of Study Archiving"},"content":{"rendered":"\r\n<p>Research record retention requirements, including the length of time files must be retained, are mandated by FDA regulations, ICH guidelines, non-U.S. regulatory agencies, and the sponsoring company\u2019s SOPs. After a study closes, retention requirements are minimally two years but often exceed 15-30 years. The common requirements for the storage of research patient case histories and essential documents (TMF) include:\u00a0<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>Continual secure protection\u00a0with limited access to\u00a0patient\u00a0and trial\u00a0data\u00a0<\/li>\r\n<li>Complete, readily available files that are\u00a0accessible for inspection\u00a0<\/li>\r\n<li>Assurances of safety\u00a0from\u00a0issues such as\u00a0fires, water damage, pests, etc.\u00a0<\/li>\r\n<li>Ongoing documentation of archive\u00a0locations; sites\u00a0to notify the sponsor\/CRO if the location changes\u00a0<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>For bulky\u00a0paper records,\u00a0it can be difficult\u00a0to find\u00a0enough,\u00a0safe, secure\u00a0space\u00a0for archiving\u00a0within a site\u2019s\u00a0facility. Alternatively,\u00a0the study files can be moved to an outside storage facility. However,\u00a0it can be expensive and inconvenient to purchase\u00a0secure storage\u00a0and move the study files to\u00a0an outside facility with the capacity needed to\u00a0compliantly\u00a0accommodate the documents.\u00a0If an audit is needed, the documents have to be brought back to the research site, incurring additional fees and transportation costs. The documents then need to be organized in readiness for the audit.\u00a0<\/p>\r\n\r\n\r\n\r\n<p>With the increased\u00a0use of\u00a0secure portals and\u00a0electronic data capture, the need for\u00a0paper\u00a0records\u00a0has decreased\u00a0and may eventually disappear. However,\u00a0many studies still use paper CRFs and regulatory documents or a mix of paper and\u00a0electronic data,\u00a0necessitating\u00a0costly, inconvenient archiving.\u00a0<\/p>\r\n\r\n\r\n\r\n<p>In time,\u00a0clinical study files\u00a0may\u00a0become fully\u00a0digital. Until this\u00a0occurs,\u00a0solutions exist to\u00a0provide complete, compliant\u00a0digital study archives, saving\u00a0space and long-term\u00a0costs. There\u2019s also a\u00a0greater chance\u00a0that a\u00a0digitally archived study could be more conveniently\u00a0stored at\u00a0the site. If\u00a0an\u00a0audit\u00a0is required, digital records are already organized, complete,\u00a0and ready for review\u00a0at any time.\u00a0<\/p>\r\n\r\n\r\n\r\n<p>Imperial offers a dedicated, secure,\u00a0and highly efficient\u00a0solution for\u00a0study document archiving.\u00a0\u00a0<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>Study\u00a0data and associated documents\u00a0are\u00a0directly\u00a0obtained\u00a0from various EDC vendors or customer-supplied media.\u00a0\u00a0<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>When the data is ready for archiving,\u00a0a\u00a0permanent\u00a0electronic\u00a0record of the subject files, completion guidelines, associated documents, as well as a composite trial master file\u00a0are created and delivered.\u00a0\u00a0<\/li>\r\n<li>The\u00a0permanent archives\u00a0are\u00a0promptly\u00a0delivered\u00a0to trial sites or study managers located anywhere in the world.\u00a0\u00a0<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>Complete, secure, safe,\u00a0archival of study documents is required and a study\u00a0must remain\u00a0fully available for regulatory review,\u00a0upon request. Find\u00a0a painless, compliant\u00a0digital archive\u00a0solution for your study.\u00a0<\/p>\r\n\r\n\r\n\r\n<p>Contact Imperial to hear more about our solution by emailing <a href=\"mailto:connect@imperialcrs.com\">connect@imperialcrs.com<\/a> or calling\u00a0800.777.2591.\u00a0<\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>Research record retention requirements, including the length of time files must be retained, are mandated by FDA regulations, ICH guidelines, non-U.S. regulatory agencies, and the sponsoring company\u2019s SOPs. After a study closes, retention requirements are minimally two years but often exceed 15-30 years. The common&hellip;<\/p>\n","protected":false},"author":11,"featured_media":69524,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[41],"tags":[1158,1163,1164,1160,551,1161,455,1157,1159,1162],"class_list":["post-68213","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-imperial-graphics","tag-archiving-best-practices","tag-archiving-clinical-trial-data","tag-archiving-study-documents","tag-clinical-research-archiving","tag-clinical-trial-documentation","tag-document-archiving-process","tag-regulatory-compliance","tag-study-archiving","tag-study-archiving-solutions","tag-study-closeout"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>How to Take the Pain Out of Study Archiving - Imperial Clinical Research Services Blog<\/title>\n<meta name=\"description\" content=\"With the increased\u00a0use of\u00a0secure portals and\u00a0electronic data capture, the need for\u00a0paper\u00a0records\u00a0has decreased\u00a0and may eventually disappear. 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