Study Director Training

1
Study Director Training

• OMB Workshop

2
Review/Select Methodology

• Is method technically sound?
• Is SLV data available, and does data meet AOAC
  requirements?
• Can method be run in other labs?

3
Method Write Up

• Follow AOAC guidelines for method write up.
• Templates being developed
• http//www.aoac.org/vmeth/Manual_Part_8.pdf
• Methods should be written for clarity and with
  sufficient detail so that other analysts can
  follow the method without confusion

4
In-House Validation

• If SLV data does not already exist, the data must
  first be generated
• SLV data must cover the intended scope and
  applicability of the method
• Samples must be chosen accordingly
• SLV Protocol is first written
• Follow AOAC SLV guidelines
• Template being generated

5
Write SLV Manuscript

• Appropriate committee and general referee will
  review manuscript for technical soundness and
  suitability of validation data.
• Study Director must respond to questions/concerns
  from committee chair and general referee.
• Assuming there are no major issues, method can
  then be recommended for a collaborative study.

6
Design Collaborative Study

• Major goal of collaborative study is to determine
  method reproducibility.
• Follow AOAC guidelines (OMA Program Manual) for a
  collaborative study.
• Templates being created
• http//www.aoac.org/vmeth/Manual_Part_6.pdf

7
Design Collaborative Study

• Select samples
• Must cover the intended scope and applicability
  of the method.
• Must be blinded as to content for the
  collaborating labs.
• May be sent as blind duplicates or Youden pairs.
• A minimum of 5 test materials must be selected.
• Consult with GR for sample selection.
• Include practice samples.

8
Design Collaborative Study

• Select Laboratories
• AOAC Staff, GR, methods committee can aid in
  finding willing laboratories
• Send formal Letter of Invitation to laboratories

9
Write Collaborative Study Protocol

• Follow AOAC Template
• Study Title
• Study Director/Contact Information
• Introduction
• Background on the method
• Goals/purpose of the study
• Description of approach (i.e. why is this method
  better than others)
• Scope and applicability of the method
• Principle of the method

10
Write Collaborative Study Protocol

• Collaborators
• Any organizations/affiliations that will take
  part in the study
• Number of planned collaborators
• Contact information of collaborators
• Can be attached to protocol as an appendix

11
Write Collaborative Study Protocol

• Study design
• Indicate number of materials
• Blind duplicates/Youden Pairs
• Blanks
• Indicate what are used for blanks
• Postive/Negative controls if used
• Number of levels, if applicable

12
Write Collaborative Study Protocol

• Test Sample Preparation
• Describe the preparation of individual test
  samples
• How will samples be shipped and stored?
• What is the stability of the samples?

13
Write Collaborative Study Protocol

• Include the method in the protocol
• List any apparatus/reagents
• Include suppliers contact information if needed
• Include calculations with units.
• Include any special precautions, controls,
  alerts, etc. that should be heeded.

14
Write Collaborative Study Protocol

• Provide instructions and forms for reporting raw
  data.
• Units
• Number of significant figures
• Describe how data will be analyzed, and what
  performance characteristics will be determined
• Reproducibility
• Repeatability
• Recovery

15
Write Collaborative Study Protocol

• Appendices, Figures, Tables
• Supporting Data
• SLV Manuscript
• Respond to GR and committee chair comments, and
  revise protocol if needed.

16
Conduct Collaborative Study

• Send out samples and protocols to laboratories
• Review data from practice samples
• Give go-ahead to laboratories that have
  successfully completed practice samples
• Follow up with questions/problems for
  laboratories
• Do not provide any information regarding sample
  content identity
• Labs must follow protocol exactly

17
Conduct Collaborative Study

• Receive and organize data from laboratories
• Analyze data and perform statistical analyses
• AOACI Interlaboratory Statistical Program from
  Joanna Lynch

18
Data Analyses

• Reproducibility
• SR and RSDR
• HORRAT
• Repeatability (if applicable)
• Sr and RSDr
• Recovery (if applicable)
• Outliers

19
Write Collaborative Study Manuscript

• Follow AOAC Guidelines
• Make recommendation regarding method
• Is it suitable for Official First Action?
• Is the method suitable for all intended analytes
  and matrices?
• Respond to comments from GR and committee chair.

20
Communication

• Report method status regularly (via reports) to
  GR
• These reports are included in annual GR report
• Respond to any comments from GR and committee
  chair
• Address comments from end-users of method
• Report any problems/issues encountered with
  method to GR