General Referee Training

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General Referee Training

• Mary W. Trucksess, Ph.D.
• AOACI General Referee for Mycotoxins
• Food and Drug Administration
• College Park, Maryland

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What is A General Referee?

• General Referee Bridges the gap between Study
  Directors of methods and the AOAC Methods
  Committee
• General Referee serves as key Technical Expert
  for the first round of Peer Review.

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General Referees Qualification

• Knowledge specialized area and topics
• Skill technical and team work experience
• Ability problem analysis, problem solving and
  effective communication

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General Referees Qualification

• You need to be passionate about your science and
  your field of interest. 
• You must passionately want to advance the
  knowledge base of your science and promote the
  analytical capabilities relevant to your
  science. 

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General Referees Qualification

• You understand that being a GR is important
  because
• You realize how vitally important validated
  methods are for promoting human health, safety,
  and comfort.
• You realize validated methods are important as
  instruments for sound regulation
• You realize the validated methods serve as
  instruments of fair trade.

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What are GRs responsibilities?

• Keep abreast of current methods
• Recommend Topic Advisors
• Prepare GR annual report
• Present Poster of GR report

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What are GRs responsibilities?

• Attend annual meeting and present report to
  appropriate Methods Committee
• Up-date Official MethodSM in OMA
• Can be OMA Chapter Editor
• Participate in phone conferences

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What are GRs responsibilities?

• Identify methods needed
• Search for Study Director
• Provide guidance to Study Director
• Review Protocol
• Review Study Report (manuscript) and make
  recommendation to Appropriate Area Committee

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AOAC Method Validation Programs

• Single Laboratory Validation Methods
• Multi Laboratory Validation Methods
• Research Institute Approved Methods
• Official MethodsSM

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Common Elements of All Methods

• In-house methods comparison study
• In-house validation data
• Proprietary or non-proprietary
• Quantitative or Qualitative

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AOAC Method Approval Process

• 1. Study director prepares protocol of study
• 2. GR reviews, comments, and approve protocol
• 3. Study director conducts study and prepares
  study report (or manuscript)
• 4. GR reviews report (manuscript, comments

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AOAC Method Approval Process

• GR recommends for approval or rejection of the
  method
• GR prepares method applicability statement
  (analyte, level of determination, commodity)

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AOAC Method Approval Process

• Official method
• GR recommends First Action Official Method,
  Method Committee concurs with GR and approves
  method as First Action Official Method.
• GR evaluates and recommends First Action
  Official Method after two years for Final Action
  status.
• GR may also be asked to review RI and PVM methods

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Study Protocol Review

• Make sure study protocol follows AOAC guidelines
• Identify method type method modification, new
  method, or matrix extension
• Evaluate in-house data and expected statistical
  results

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Study Protocol Review

• Examine test sample preparation, practice
  samples, method of spiking, calibrators or
  standards, procedure clarity, critical control
  points, and instruction to collaborators
• Consult AOAC statistician and safety officer if
  necessary
• Evaluate study time line

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Study Manuscript or Report Review

• Parameter OM RI SLV MLV
• Ruggedness X X X X
• RSDr X X X X
• RSDR X X X
• Specificity X X X X
• Sensitivity X X X X
• LOD X X X X
• LOQ X X X X
• HORRAT X X X

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Manuscript or Report Review

• Parameter OM RI SLV MLV
• Manufacturer QA X
• Product stability X
• Lot-to-lot consistency X
• Package insert review X

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Preparation of Annual GR Report

• Contact Topic Advisors periodically
• Notify Topic Advisors deadline for annual report
• Set deadline for Topic Reports
• Request progress reports from Study Directors

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Content of Annual GR Report

• Method Status
• International Activities Codex activities
• Literature Review
• Incidence and Occurrence of the Analyte or
  Analytes

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Content of Annual GR Report

• Decontamination and Processing
• Recommendation Research focus, method needs,
  new topics or topic advisors, topic continuation
  or topic termination

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Where can GRs find information?

• Communicate with AOAC Method Committee
• Communicate with Area Method Committee Chair and
  members
• Communicate with Topic Advisors
• Contact research scientists nationwide and
  internationally
• Literature search

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Reward for Being a General Referee

• Gain prestige and pride
• Network with other scientists, manufacturers, and
  government agencies
• Maintain contact with special interest groups
• Obtain up-to-date information

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Reward for Being a General Referee

• Improve knowledge, skill, ability and job
  performance