How to Apply the Golden Rule of Research to Your Trial Master File

Good Documentation Practice (GDP) is the  cornerstone to ensuring a quality, inspection ready Trial Master File (TMF). TMF experts, LMK Clinical Research strongly believe that GDP is the responsibility of everyone that contributes (i.e. via submission or creation) clinical trial documentation to the TMF.

In this whitepaper, LMK evaluates the following:

  • Regulations that support GDP

  • Best practices on how document contributors can apply the golden rule of research to their TMF

  • How to avoid writing too many and unnecessary Note-to-Files (NTFs)

  • Tips on becoming inspection ready and staying that way


    WHITEPAPER Contributors:

    Company team

    Sholeh Ehdaivand, Principal Consultant and President

    LMK Clinical Research

    Sholeh is an internationally known TMF Subject Matter Expert with over 15 successful years of experience in the Clinical Research Industry. Her expertise and knowledge in all areas of study management and operational aspects of the clinical trial and document management processes has made her a leader and trusted expert.

    Her experience includes the TMF Reference Model Subject Matter Expert, eTMF management, domestic and international pharmaceutical and biological clinical trials, clinical trial management, site selection, vendor relations, electronic document management, regulatory submissions, quality control processes and implementation and regulatory inspection preparation and participation. Read More

    Company team

    Jackie Morrill, Director of Clinical Operations

    LMK Clinical Research

    Jackie Morrill is a Lean Six Sigma Green Belt certified clinical research professional with nearly a decade of experience in clinical trial coordination and process improvement within the healthcare, biotech, and pharmaceutical industries.

    In recent years, her dedicated focus has been on all things Trial Master File (TMF). Her experience includes oversight of electronic TMF (eTMF) implementation, coordination of a large migration project to move 20+ studies from a paper and/or hybrid TMF to an eTMF, development of a robust metrics and training program, a complete overhaul of TMF QC processes, and extensive inspection readiness preparation for FDA, MHRA, and PDMA inspections. Read More

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