Blog Posts
Avoiding the Naughty List: Inspection Readiness at the 8th TMF Summit
With lights in the trees, wreaths on the doors, and Mariah Carey’s ‘All I Want for Christmas’ playing on every other radio station, it must be that time of year again… time to prepare for the annual Trial Master File Summit in Orlando! This year, LMK Clinical Research Consulting (LMK) is feeling extra festive,…
Read MoreLMK Remembers the 100th Anniversary of World War I
LMK Clinical Research Consulting recognizes our debt to all veterans, past and present. We acknowledge their sacrifice that ensures all Americans may share in our most important principles of freedom, justice, and liberty. These fundamental principles are the foundation of all worthwhile scientific and medical advancement. November 11th, 2018 marks the 100th year anniversary of…
Read MoreHow To: How to Decide When to Write a Note to File
About LMK’s How-To Series LMK’s commitment to education inspires our most popular and most important service offering: TMF University. TMF University is LMK’s industry-first TMF training program, offering a wide range of courses to suit all needs; from beginners just learning to identify common regulatory documents to professionals seeking to hone their expertise. Celebrating…
Read MoreHow To: Make Sense of an Unfamiliar TMF
About LMK’s How-To Series LMK’s commitment to education inspires our most popular and most important service offering: TMF University. TMF University is LMK’s industry-first TMF training program, offering a wide range of courses to suit all needs; from beginners just learning to identify common regulatory documents to professionals seeking to hone their expertise. Celebrating…
Read MoreHow To: Determine on What TMF Level a Document Should Be Filed
About LMK’s How-To Series LMK’s commitment to education inspires our most popular and most important service offering: TMF University. TMF University is LMK’s industry-first TMF training program, offering a wide range of courses to suit all needs; from beginners just learning to identify common regulatory documents to professionals seeking to hone their expertise. Celebrating…
Read MoreHow To: Use the TMF Reference Model
About LMK’s How-To Series What makes someone an expert? Does it take a title, authority, or skill? At LMK we believe an expert, above all, is someone with the heart of a teacher—someone who doesn’t just possess advanced knowledge but is also willing to share that knowledge for the benefit of all. LMK’s commitment…
Read MoreNontransferable Obligations: Why Sponsors Fail Inspections Part Two: Inadequate Procedures
In part one of our two-part series on FDA inspection of sponsors, we confirmed that no matter the extent of the responsibility delegated away to a CRO or other service provider, “the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor” (ICH GCP 5.2.1). We also discussed…
Read MoreSurviving Protocol Amendments: Preparation is Key
Of all the challenging aspects of managing a Trial Master File (TMF), grappling with a high number of protocol amendments nears the top of the list. With every new amendment comes the need to produce, track, and file all the documents that have changed in tandem with the amendment. The number of documents that may…
Read MoreDiagnosing Double Vision
One of the golden rules of Trial Master File (TMF) management is to avoid duplicate filing of documents. We all know that the primary objectives of the TMF is to provide step-by-step documentation of the clinical trial and to protect the rights of patients. It is also vitally important for the TMF to facilitate, and…
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