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Standardization and Best Practices for Sample Methodologies in Clinical Research

This document outlines the essential standardization methods for sample handling, including the development of synthetic standards, SOPs for instrument standardization, and intra/inter-batch normalization. Additionally, it discusses calibration of local pool samples to NIST standards and the production SOP for local pools. Key contributors, including Jean-Charles Martin and Richard Beger, emphasize the importance of empirical feedback and performance indicators for quantitative improvements. Various sample types, including urine, tissue, and faecal samples, are discussed, with a focus on best practices and inventory management strategies.

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Standardization and Best Practices for Sample Methodologies in Clinical Research

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  1. Standardization of methods • Sample standards • Synthetic standard • SOP’s • Instrument standardisation • Normalisation (intra- and interbatch) • Pre-processing of data

  2. Sample standards • NIST + local pool sample (plasma) • Calibrate the local pool to the NIST • Local pool production SOP (method dev. /QC/etc) • Jean-Charles Martin, Richard Beger, Anne-Marie Bayle, Ronald Aardema • Urine • Anybody making a representative sample? Lars • Tissue • White adipose tissue (human), Muscle & Liver (animal/cow/pig) • Anybody hospital contacts? • Faecal samples?

  3. Synthetic standard • Feedback required A.S.A.P. • Performance indicators • Coverage, Improve quantitation?, System performance indicator, use as intra/inter-batch corrector? • Send SOP out to volunteers/new version will be uploaded soon • Send a mail to ThaerBarri

  4. SOP’s • Version control • Blog, automatic mail/reminders (new version/alert for update • Sample shipment SOP • Thaer, Ivana Bobeldijk, John Newman(?), Rob Vreeken • Batch build-up • Ronald, Daniela

  5. Instrument Standardisation • Best practices/routines/SST(synthetic standard) • Jean-Charles Martin, Rob, Thaer, John Newman(?)

  6. Pre-processing of data • Inventory of used strategies • Jildau • Collection of R-procedures to go into Excel • John Newman, Bruce Kristal, Manfred, Adrie Dane

  7. Working committee • Rob Vreeken • Lars OveDragsted • Jildau Bauman • Jean Charles Martin • Ronald Aardema • Richard Beger • Estelle Pujos • Mark Philo • Sonja Peters • Maria Vinaixa • MetteSkouHedermann • Marie-Laure Bayle • Thaer Bari • Miguel Rodriguez • John Newman • Ivana Bobeldijk-Pastorova

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