{"id":350388,"date":"2023-11-21T11:15:02","date_gmt":"2023-11-21T16:15:02","guid":{"rendered":"https:\/\/platohealth.ai\/from-feasts-to-files-thanksgiving-traditions-and-tmf-standards-lmk-clinical-research-llc\/"},"modified":"2023-11-21T17:49:01","modified_gmt":"2023-11-21T22:49:01","slug":"from-feasts-to-files-thanksgiving-traditions-and-tmf-standards-lmk-clinical-research-llc","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/from-feasts-to-files-thanksgiving-traditions-and-tmf-standards-lmk-clinical-research-llc\/","title":{"rendered":"From Feasts to Files: Thanksgiving Traditions and TMF Standards – LMK Clinical Research, LLC","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
As the crisp, frost-kissed mornings of autumn embrace us, the passage of time seems to accelerate. In the blink of an eye, we transition from fall\u2019s embrace to the glittering threshold of New Year\u2019s Eve. This swift journey through the holidays prompts a moment of reflection on the fluid nature of life. It\u2019s not just the shifting of seasons, the evolving array of dishes adorning our Thanksgiving tables, or even the dynamic regulations shaping your Trial Master File (TMF) \u2013 it\u2019s the very essence of change itself. This change, ever-present and inevitable, also brings into focus the constants in our lives, those precious elements for which we hold deep gratitude.\u201d<\/p>\n
The traditional Thanksgiving menu has been far from static. Like most traditions, the \u2018Thanksgiving Story\u2019 and the meal contained within are more legend than historical reality\u2014Americans did not fully embrace Thanksgiving nationally until the 1860s. As far as the existing historical accounts go, there are quite a few myths to be busted:<\/p>\n
Like the dishes on the Thanksgiving table, the regulation of clinical trials and the TMF is far from set in stone; the recent emphasis on the ICH GCP, EMA Clinical Trial Regulation and Guidance, the MHRA Gray Guide, and FDA 21 CFR Part 11 is a testament to this constant change. These regulations form the foundation of every TMF and therefore every clinical trial. They emphasize the growing importance and complexity of TMF, indicating a heightened focus on regulatory compliance in clinical trials. Here are some of the basic principles of good document practices as outlined in these regulations:<\/p>\n
Change can be uncomfortable, but oftentimes it\u2019s for the best (aren\u2019t we all glad that corn mush is no longer on the Thanksgiving table?). The advancement of new technology and the regulations to support it, specifically surrounding the TMF, can seem relentless, but with this relentless pace comes the promise of accelerated clinical development. At LMK, we\u2019re happy to see this progress, but firmly believe that technology alone is never the best solution. We\u2019re truly thankful it\u2019s our job to be the ambassadors of change in our industry; empowering the best people with the right tools\u2014and ultimately uniting patients with life-changing treatments.<\/p>\n
As the crisp, frost-kissed mornings of autumn embrace us, the passage of time seems to accelerate. In the blink of an eye, we transition from fall\u2019s embrace to the glittering threshold of New Year\u2019s Eve. This swift journey through the holidays prompts a moment of reflection on the fluid nature of life. It\u2019s not just […]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":350391,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[49],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/350388"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=350388"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/350388\/revisions"}],"predecessor-version":[{"id":350390,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/350388\/revisions\/350390"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/350391"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=350388"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=350388"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=350388"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}