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EP39: Surrogate Sample Framework

CLSI requests nominations for volunteers to serve as members and contributors on a document development committee for a new document.

Description

CLSI document EP39 will provide information on the use of surrogate samples in in vitro diagnostic (IVD) test development and in studies used for regulatory submission. Topics covered in the guideline will include:

  • Creating a uniform definition of surrogate samples, with a diverse array of examples
  • Outlining general principles and considerations when designing and selecting surrogate samples
  • Presenting a hierarchy of surrogate sample selection and design
  • Establishing study-specific principles accompanied by a hierarchy for each study type

This group is looking for volunteers with:

  • Experience or expertise in surrogate sample development
  • Experience in the use of surrogate samples
  • IVD test manufacturing or laboratory-developed test experience
  • Knowledge of regulatory and accreditation requirements related to surrogate samples

Additional information on essential job duties and skills and abilities for CLSI committee participants can be viewed here.

Timeline for this project

September 26 and 27, 2018: First face-to-face meeting (NOTE: This will be a 2-day meeting scheduled during the September Committees Week in San Antonio, Texas.)
October 2018 to July 2019: Drafting of document (higher-intensity volunteer time period)
October 2019 to December 2019: Voting period for draft document
January 2020 to February 2020: Revision of draft based on comments received during voting
October 2020: Expected publication date

Due date for submission of required documentation

Please submit nominations and required documentation (see Requirements for Nomination Consideration) on or before May 7, 2018 to volunteer@clsi.org.